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1. The Burden of Self-Reported Rhinitis and Associated Risk for Exacerbations with Moderate-Severe Asthma in Primary Care Patients

Author: Kritikos, Vicky, Price, David, Papi, Alberto, Infantino, Antonio, Ställberg, Björn, Ryan, Dermot, Lavorini, Federico, Chrystyn, Henry, Haughney, John, Lisspers, Karin, Gruffydd-Jones, Kevin, Román Rodríguez, Miguel, Høegh Henrichsen, Svein, van der Molen, Thys, Carter, Victoria, and Bosnic-Anticevich, Sinthia
Subjects: lcsh:Immunologic diseases. Allergy, preventer, Respiratory Medicine and Allergy, Socio-culturale, oral steroids, comorbidities, side effects, asthma symptom control, reliever, side-effects, asthma symptom control, comorbidities, oral steroids, preventer, reliever, side effects, Journal of Asthma and Allergy, lcsh:RC581-607, Lungmedicin och allergi, Original Research
Abstract: Purpose: There is a dearth of research regarding the prevalence and nature of patient-reported rhinitis and its relationship with risk of asthma exacerbations. The aim of this study was to (i) determine the prevalence, severity and treatment of self-reported rhinitis symptoms among adults aged >= 18 years with asthma treated at Global Initiative for Asthma (GINA) Step 3 and above and (ii) compare the demographics, clinical characteristics, medication use, side-effects and healthcare practitioner review between patients who report rhinitis symptoms and those who do not and (iii) determine whether patient-reported rhinitis is associated with risk of asthma exacerbations in the total patient sample. Patients and Methods: This analysis used data from the iHARP (Initiative Helping Asthma in Real-life Patients) asthma review service - a cross-sectional observational study (2011 and 2014) in seven countries that captured data on patient demographics, rhinitis symptoms, asthma symptoms, indicators of exacerbations, medication use, oropharyngeal effects and side-effects, using practitioner- and patient-reported questionnaires. Comparisons between patients with and without rhinitis were tested. Univariate logistic regression was used to identify variables associated with risk of exacerbations for entry into multivariable logistic regression. Results: This report contains data from 4274 patients: 67.4% (2881/4274) reported rhinitis symptoms and of which 65.7% (1894/2881) had not received a doctor diagnosis; 36.5% (1052/2881) had moderate-severe rhinitis, 12.4% (358/2881) had used intranasal corticosteroids and 19.8% (569/2881) oral antihistamines. Patients with coexisting moderate-severe rhinitis were more likely to have GINA-defined uncontrolled asthma than those with mild rhinitis or no rhinitis. Moderate-severe rhinitis was associated with 40% increased risk of asthma exacerbations (OR=1.40, 95% CI: 1.02-1.90). Conclusion: This study identified a major gap in the diagnosis and management of rhinitis in a cohort of people with asthma treated at GINA Step 3 and above who are managed in general practice. It highlights the need for practitioners to identify, evaluate and optimally treat rhinitis in adults with asthma, which is a significant factor associated with exacerbation risk., The iHARP database was funded by unrestricted grants from Mundipharma International Limited and Optimum Patient Care Global Ltd, which is a social enterprise that focuses on quality improvement in clinical practice. The sponsor was not involved in data analysis or the interpretation of the results.
Published: 2020

2. 2. Research databases in Catalonia

Author: Ryan, Dermot, Miravitlles, Marc, Chrystyn, Henry, Gruffydd-Jones, Kevin, Haughney, John, Roche, Nicolas, Lavorini, Federico, Papi, Alberto, Infantino, Antonio, Román-Rodríguez, Miguel, Bosnic-Anticevich, Sinthia, Lisspers, Karin, Ställberg, Björn, Henrichsen, Svein H, van der Molen, Thys, Carter, Victoria, Ashton, Valerie L, Price, David, van Ganse, Eric, Belhassen, Manon, Kaplan, Alan, Sullaiman, I, MacHale, E, Holmes, M, Jackson, M, Reilly, RB, Costello, RW, Roman Rodriguez, Miguel, Henrichsen, Svein, Lim, Daina, Steel, Jo, Kritikos, Vicky, Kreuzaler, Sandra, Nikolaou, Vasilis, Bjermer, Leif, Dekhuijzen, PN Richard, Rand, Cynthia, Smith, Lorraine, Pont, Lisa, Shah, Smita, Zwar, Nicholas, Gopalan, Gokul, Shu, Youyi, Virchow, J Christian, Davis, Emily, Molimard, Mathieu, Shan, Dawn, Sims, Erika, Burden, Anne, Efthimiou, John, Ferkl, Marek, Kemppinen, Anu, Pironti, Valentino, Thomas, Vicky, Brady, Adam, Steele, Jo, McLoughlin, Andrew, Juniper, Elizabeth F, Barnes, Peter, Usmani, Omar, McIvor, R Andrew, Freeman, Daryl, Gerrard, Val, Turton, Jan, Løkke, Anders, Hilberg, Ole, Tønnesen, Philip, Kjellberg, Jakob, Ibsen, Rikke, Jennum, Poul, Herings, Ron MC, Overbeek, Jetty, Miglio, Cristiana, Dekhuijzen, Richard, Martin, Richard, Postma, Dirkje, van Aalderen, Wim, Tan, Ngiap Chuan, Campbell, Jonathan D, Barrecheguren, Miriam, Monteagudo, Mónica, Esquinas, Cristina, Ferrer, Jaume, Borrell, Eulalia, Llor, Carl, Simonet, Pere, Rodríguez, Esther, Small, Iain, Wolfe, Stephanie, Hamil, John, Daly, Cathal, Lim, D, Miravitlles, M, Haughney, J, Usmani, O, Roman-Rodriguez, M, Russell, R, Singh, D, von Ziegenweidt, J, Price, D, Souverein, Patrick C, Koster, Ellen S, Dima, Alex L, Colice, Gene, Schermer, Tjard, and Wong, Gary
Subjects: Abstracts
Abstract: Current guidelines typically adopt a mechanistic approach to therapeutic management rather than a more individualized approach, guided by analysis of a patient’s problems. The result is that many patients end up on high levels of medications, possibly over-treated, yet uncontrolled. Guidelines currently recommend solutions based on the mean outcomes from registration trials. As such, they are probably applicable to only around 5% of the respiratory population that lies either side of that mean and not the majority of patients, eg, those with comorbidities and lifestyle complications. While the guidelines’ approach puts evidence at the center of their decision making, an evidence-based approach that will benefit the patient must put the patient at the center and adapt the available evidence to their specific needs. Examination of databases goes some way to seeing what happens in real-life and (to some degree) reflects this more patient-centric approach to evaluation of the evidence. By considering the interaction between elements of real-life management (eg, inhaler handling, patient preference, adherence, comorbidities, smoking status) and treatment outcomes, real-life research can help to achieve more tailored, individualized patient management. Inhalers are the most important tools for administration of medication for respiratory disease: a critical success factor of therapy lies in successful administration. By examining different databases from different parts of the world, separately, comparatively or in aggregate, it may also be possible to: identify health care systems that achieve better outcomes (identify the reasons for that differentiation) and to demonstrate real differences in disease prevalence between regions and countries, and possible differences in etiology, which may identify opportunities for developing different approaches to primary prevention (eg, Finnish Allergy Program). If the benefits of treatment to the individual patient are maximized, the aggregate of individual patient optimizations should generate more cost-efficient employment of resources with benefits for the individual and the health care system as a whole. For relatively rare diseases, combining databases from expert centers may well provide clues concerning management optimization (eg, cystic fibrosis and idiopathic lung disease). Such knowledge may also enable us to construct more integrated and streamlined pathways of care, concentrating scarce resources in the centers of excellence and operating (for example) on a hub-and-spoke system – our knowledge of flu depends on such database interactions. Looking to the future, comparative or aggregative database work can save time by constructing databases and introducing common coding and data fields to facilitate information exchange that is valid and reliable, thus avoiding the need to replicate costly work as encountered by the International Primary Care Respiratory Group (IPCRG’s) UNLOCK (Uncovering and Noting Long-term Outcomes in COPD and asthma to enhance Knowledge) database group., In recent years we have developed different epidemiological studies with data obtained from the Information System for Development in Research in Primary Care, a population database that contains information of 5.8 million inhabitants (80% of Catalonia’s population). In one of them newly diagnosed COPD patients in the years 2007–2012 were identified through a diagnostic algorithm, and patients with a diagnostic spirometry were included and classified based on GOLD severity stages. Information about the initial treatment patterns was collected. No information regarding Modified Medical Research Council Dyspnea Scale (mMRC) or the COPD assessment test (CAT) was available but previous diagnosis of asthma and exacerbations during the previous year were collected. We identified 15,312 patients with newly diagnosed COPD. The frequency of patients with a previous diagnosis of asthma or frequent exacerbations was similar between groups (up to 6.6% of patients with previous asthma and 24.5% of frequent exacerbations). Regarding treatment, milder patients were more likely to receive short-acting bronchodilators in monotherapy (21% of patients in GOLD 1 versus 14.8% in GOLD 4) or no treatment after diagnosis (38.7% GOLD 1 versus 13.6% GOLD 4) while patients in GOLD 4 received triple therapy more frequently compared to GOLD 1 (36.6% versus 5.7%). Few patients were treated with double therapy (from 1.6% patients in GOLD 1 to 4% in GOLD 3). The percentage of patients treated with inhaled corticosteroid was higher in the severe groups (28.3%, 37.3%, 51.3%, 59.3% for GOLD 1 to 4 respectively). Other studies are ongoing on the prevalence of AAT determinations in primary care and the compliance with once daily and twice daily long-acting muscarinic antagonists in COPD in primary care., Background The large-scale international implementing Helping Asthma in Real People (iHARP) project, which arose from the pilot project in Ireland in 2009, aims to improve the management of patients with moderate-to-severe asthma using validated assessment tools. The database that emanated from the iHARP project is described here. Methods Five thousand adult patients with asthma (≥16 years old) were recruited from the UK (60%), the Netherlands (14%), Spain (11%), Italy (8%), Australia (4%), Sweden (1%), Norway (1%), and France (0.5%) from June 2011 to December 2014. The patients had ≥2 prescriptions for fixed-dose combination inhaled corticosteroid/long-acting β- agonist therapy delivered via a dry powder inhaler or metered dose inhaler (with or without spacers) in the year before their respiratory consultation. The iHARP data were collected during respiratory consultations with trained health care practitioners, from patient-completed asthma questionnaires and when available from linked electronic medical records. Results Variables and examples from the iHARP database are shown (Table 1). Conclusion The international iHARP database is a rich repository of clinical data, including inhaler technique assessment measures, and details about rhinitis diagnosis, symptoms, and severity, from patients with moderate-to-severe asthma. The data will be a valuable asset for performing robust, real-life, observational research in asthma., Background The need to identify and develop validated tools to assess asthma control and understand the reasons for poor control in individual patients, triggered the development of the international implementing Helping Asthma in Real People (iHARP) project (Figure 1). Since then the role of fractional exhaled nitric oxide (FeNO) as a diagnostic and decision-support is well documented and can be explored further using the iHARP database. Methods Seven hundred and nine patients from the UK performed FeNO assessments as part of standard asthma reviews with trained health care practitioners. The patients had ≥2 prescriptions for fixed-dose combination inhaled corticosteroid/long-acting β-agonist therapy delivered via a dry powder inhaler or metered dose inhaler (with or without spacers) in the year before their respiratory consultation. The iHARP data were collected during respiratory consultations from patient-completed asthma questionnaires and when with linked electronic medical records. Results Table 1 describes the patient population and further explores the potential reasons for poor asthma control with FeNO readings. Conclusion The international iHARP database is a rich repository of clinical data, including blood eosinophil readings and inhaler technique assessment measures, from patients with asthma. FeNO readings collected during iHARP asthma reviews will be a valuable asset for performing robust, real-life, observational research. It is planned for 1 year follow-up data to be collected, which will facilitate the assessment of FeNO as a predictive tool in the management and risk assessment of patients with asthma., Background France has a publicly funded health insurance system, covering the whole population. The Système national d’information inter-régimes de l’Assurance maladie (SNIIRAM) records all claims of medical resource utilization from the national population, including the PMSI (Programme Médicalisé des Systèmes d’Information or Medicalized Program of Information System, ie, hospital activity and expenditure data). The EGB (échantillon général des bénéficiaires), a 1% random sample of the SNIIRAM, is also available for research projects. Aim To describe claims data available in France for observational research, ie, SNIIRAM and EGB, and to provide examples of studies conducted with these resources. Methods SNIIRAM and EGB will be described, with advantages and limitations. Access to these resources and organization of data management and analysis will be discussed. Finally, three projects will be briefly presented to illustrate the interest of using French claims data, more specifically in respiratory medicine/allergy: – the “RATIO project”, conducted on EGB data to identify asthma patients at risk of adverse outcomes;– the “APSI project”, conducted on EGB data to identify the effectiveness of oral immunotherapy in allergic rhinitis patients;– the “SINGULAIR project”, a comparative effectiveness study of montelukast and inhaled corticosteroids in infants treated for asthma. Results SNIIRAM/EGB contain exhaustive data on medical resource utilization, with individual linkages between primary (eg, medical contacts and pharmacy refills) and secondary care. EGB (N>500,000, data available since 2006) is an “improved dataset” (data cleaning, and facilitated use) accessible online after regulatory approval, while SNIIRAM (N>50 million, data available since 2009) data are extracted by the Social Security following approval of well-argued requests. In both datasets, diagnoses are missing, unless patients were hospitalized or suffer from severe conditions; results from investigations (eg, blood sampling, radiology) are also missing. Hospital stays are recorded, with details of diagnoses (International Classification of Diseases-10 codes), procedures, diagnosis related group (DRG) codes, and admission/discharge dates. Dates of death are recorded. SNIIRAM can be linked to external medical records, eg, using a trusted third party procedure. RATIO identified a group of patients at higher risk of asthma exacerbations; APSI suggested an effect of immunotherapy in children; SINGULAIR concluded to the non-inferiority of montelukast compared to inhaled corticosteroids in infants. Conclusion French reimbursement data provide high quality data on exposure to therapy, and occurrence of major outcomes in a large, longitudinal, population. Despite their limitations, they may be used to assess exhaustive individual Health Care Utilization, and to study drug use (including adherence), and positive or adverse effects of interventions in real-life setting., The Canadian Primary Care Sentinel Surveillance Network or CPCSSN is a primary care research initiative – it is the first pan-Canadian multi-disease electronic medical record surveillance system using health information from electronic medical records in the offices of participating primary care family physicians across the country. This database is still in its relative infancy. Inconsistent data entry necessitates data cleaning. For respiratory disease, COPD is currently the only one with work having been accomplished. Multiple codes have been amalgamated into COPD including chronic bronchitis, emphysema, chronic airflow obstruction not otherwise defined and the use of tiotropium, ipratropium and salbutamol as long as a diagnosis of asthma was not made. Smoking status has also been a particularly trying process, with multiple potential codes causing confusion including non-smoker, ex-smoker, smoker trying to quit, smoking, nicotine addiction etc. We will discuss opportunities for its use both in Canada and hopefully within a future Respiratory Effectiveness Group initiative., This abstract reports an interim analysis of a prospective observational cohort study designed to assess the rate, the patterns, and the drivers of adherence by COPD patients. We assessed adherence using medication belief questionnaires, pharmacy refill records, visual assessment of technique, and via an acoustic recording device attached to the inhaler (INCA™). To date we have enrolled 161 patients with COPD who have used the INCA™ adapted salmeterol/fluticasone inhaler for up to 3 months after discharge from hospital. The purpose of this study is to follow 400 patients for 90 days after an exacerbation to identify the relationship between adherence and the patient’s clinical course. The clinical characteristics of this cohort are noteworthy for the number of comorbidities (Charlson co-morbidity 5.8), the number of concurrent medications (mean 16), the presence of extreme hyperinflation, (cough peak expiratory flow rate 170), the level of health literacy (33), and the extremely high prevalence of mild cognitive impairment in this group (78%). These latter points suggest that a strategy to address adherence needs to be based on a framework used for patients with mild cognitive impairment. The calculated rate of adherence was 0.6±0.3, and the calculated rate of inhaler errors was 0.35±0.3 with combined actual rate of adherence 0.28±0.3. In the first month after discharge, the rate of use was higher in those who did not have an exacerbation 32±32 compared to those who did 19±30. Hence, it is important to evaluate adherence as part of evaluating the clinical course of a patient with COPD. Four distinct patterns of adherence were evident. Four distinct patterns of adherence were evident: (i) good adherence and good technique, which included the most cognitively intact patients and those with the best CAT scores; (ii) poor inhaler technique, but good time of use, which included patients with the lowest spirometry (suggesting technique errors that may be related to poor airflow); (iii) irregular inhaler users who had good technique, these patients had the worst Hospital Anxiety and Depression Scale (HADS) score and highest number of hospitalisations (suggesting poor motivation), (iv) poor technique and poor adherence, these patients had the lowest Montreal Cognitive Assessment (MoCA) and lowest cough peak expiratory flow rate. Hence, a comprehensive strategy to address adherence in COPD will need to adapt a framework that incorporates strategies used in the treatment of mild cognitive impairment., Background Poor inhaler technique has been identified as an important reason for sub-optimal asthma control.1 To date, inhaler technique has only been studied in a small number of studies and only in patients receiving inhaled corticosteroid monotherapy.2 Aim We aim to evaluate the prognostic role of inhaler technique and other patient- and treatment-related factors in asthma control in patients receiving fixed dose combination therapy (FDC) ± short-acting β2-agonist therapy. Methods This was an international cross-sectional observational study using data collected from the international implementing Helping Asthma in Real Patients (iHARP) review service between June 2011 and December 2014, as well as the Optimum Patient Care Research Database. It included patients with asthma, older than 16 years, who received ≥2 prescriptions for FDC inhaled corticosteroid (ICS)/long-acting β-agonist in the year prior to review via dry powder inhaler or metered dose inhalers (MDI) with or without spacer devices. Patients with a COPD diagnosis, prescribed ICS separately in addition to FDC ICS/long-acting β-agonist therapy and receiving oral corticosteroids and/or antibiotics with a lower respiratory consultation in the 2 weeks preceding their asthma review were excluded. The primary outcome was asthma control assessed by the Global Initiative for Asthma (GINA) evaluation/classification. Inhaler technique was assessed subjectively through a number of errors evaluated as “serious” (based on literature and expert group consensus) for each of the following inhaler devices: Diskus® dry powder inhaler, MDI with spacer, MDI without spacer and Turbuhaler®. Bivariate associations between the primary outcome (GINA) and the inhaler technique (as assessed by device-specific “serious” errors) were examined to assess the individual significance of each predictor. Logistic regression was used to assess the association between each error and two classifications of GINA asthma control: a) uncontrolled versus controlled/partly controlled and b) uncontrolled/partly controlled versus controlled. All analysis were stratified by type of inhaler device. Results Data from 5,010 patients were analyzed. Of these, 3,075 (61%) were from the UK, 653 (13%) were from Holland, 530 (11%) were from Spain, 420 (8%) were from Italy, 200 (4%) were from Australia, 63 (1%) were from Sweden, 48 (1%) were from Norway, and 21 (1%) were from France. A total of 1,947 patients (39%) were male, with average age of 51 (standard deviation =14) years. The most common errors identified are detailed, by device type, in Table 1. Conclusion Performing inhaler technique errors is important in real life and further emphasis needs to be placed on those device errors which significantly predict poor asthma control in clinical practice. This preliminary analyses list the initial errors identified to be associated with poor control. Further analyses are ongoing to investigate which errors have a clinical impact., Background Errors in inhaler device handling are associated with having poor asthma control. Therefore, health care practitioners (HCP) are advised to assess and train patients in the use of their inhalers at every visit. It has been shown that demonstrating correct inhaler technique to patients helps them achieve and maintain correct inhaler technique. However, few HCP demonstrate correct inhaler technique as most are often not trained in the use of inhalers. Aim This study aimed to examine the ease of device mastery for Turbuhaler® (TH) versus Spiromax (SP) by trainee HCP, based on the hypothesis that SP is more intuitive. Methods This randomized, cross-over group study comprises three visits over 2 months (Figure 1). Results of visit one are reported here. The study examined device mastery of inhaler technique in trainee HCP without asthma using empty inhaler devices. The training was structured into six levels as follows: 1 – intuitive use; 2 – patient information leaflet; 3 – instructional video; 4 – expert tuition; 5–6 repeats of expert tuition. Device errors (errors impairing drug delivery were defined by steering committee) were assessed by expert inhaler assessors. Participants were required to go through the levels in order until they had attained device mastery (ie, no observed device errors). Demographic characteristics, total number of errors, comparative device mastery at each training level, and the proportion of participants making ≥1 device errors for all levels were evaluated. Participant device preference was recorded. A sub-analysis assessed how the order of device randomization influenced device mastery. Variables were compared using chi-squared test (P, Background Improved patient adherence to treatment regimens contributes to better management of asthma. Tailored therapy according to a patient’s preference, including selection of the preferred inhalation device, has the potential to improve adherence to the device and eventual medication, which could possibly improve clinical outcomes. Aim This study evaluated the efficacy and safety of budesonide-formoterol (BF) Spiromax® compared with BF Turbuhaler® among adults and adolescents with persistent asthma. Here we present data for the secondary endpoint of patient satisfaction and preference for each device. Methods This was a Phase 3b, 12-week, multicenter (17 countries; 120 centers), randomized, double-blind, double-dummy, active-controlled, parallel-group study. The study included a screening and run-in period, followed by a 12-week, double-blind treatment period. Eligible patients (≥12 years) had persistent asthma (Asthma Control Questionnaire ≥1.0), forced expiratory volume in one second (FEV1) 40%−85% (stable for ≥30 days before the screening visit) and had used short-acting β2-agonists and inhaled corticosteroids for ≥8 weeks before screening. Patient preference to each of the devices was assessed using the Patient Satisfaction and Preference Questionnaire for Inhalation Devices (PASAPQ©; copyright by Boehringer Ingelheim International GmbH 2004). The PASAPQ includes two subscale scores (part one: performance domain and convenience domain scores) and a satisfaction score (part two: device preference and willingness to continue [using the device in the future] score). The changes from baseline (Day 1 of the double blind treatment period) to Week 12 for each of the scores were calculated for both devices. Results A total of 605 patients were randomized onto the study (mean baseline FEV1, 2.2 L), 31 patients discontinued (most frequent reason for withdrawal was protocol violation, n=8). For this analysis, 276 patients randomized to the BF Spiromax arm and 266 patients randomized to the BF Turbuhaler arm completed the PASAPQ questionnaire. The least squares (LS) mean changes for the PASAPQ performance domain scores from baseline to Week 12 were 0.212 for BF Spiromax versus 0.012 for BF Turbuhaler (P=0.0038). The LS mean changes in the PASAPQ convenience domain scores from baseline to Week 12 were 0.042 for BF Spiromax versus 0.118 for BF Turbuhaler (P=0.2206). Results from part two of the PASAPQ indicated that at baseline and at Week 12, a higher proportion of patients in both study arms expressed a device preference for Spiromax versus Turbuhaler. At baseline, 256 patients preferred Spiromax, 126 patients preferred Turbuhaler, and 155 patients had no device preference. At Week 12, 304 patients preferred Spiromax, 118 patients preferred Turbuhaler, and 115 patients had no device preference (Table 1). The device preference for Spiromax over Turbuhaler was also maintained when the population was classified by age group (Figure 1). Consistent with greater preference for the Spiromax device (albeit numerical), the change in PASAPQ “willingness to continue use” score from baseline to Week 12 was statistically significantly higher for BF Spiromax than for BF Turbuhaler (3.65 versus −3.951; P=0.0005). Conclusion This analysis has shown that more adult and adolescent asthmatics prefer the Spiromax device over the Turbuhaler device for its performance and are willing to continue therapy with BF Spiromax beyond the 12-week study period., Background The Helping Asthma in Real People (HARP) initiative was established following a call by the International Primary Care Respiratory Group (IPCRG) to identify reasons for poor asthma control in patients with asthma. HARP was a practical implementation project piloted in Ireland in 2009 using validated clinical assessment tools in real-life clinical practice. Results highlighted both sub-optimal asthma control in a high percentage of patients and the importance of capturing standardized data in managing chronic disease in primary care. After the success of HARP, a follow-on study was rolled out on a global scale: the international implementing HARP (iHARP) initiative. Here we describe this initiative, set up to improve asthma patient care through face-to-face respiratory reviews carried out by trained health care practitioners. Aim iHARP aims to provide health care professionals across the world with a support program for reviewing patients with moderate-severe asthma receiving fixed-dose combination therapy. This program includes enhanced asthma reviews, a structured inhaler technique assessment, and improved patient engagement. Methodology An international steering committee of respiratory disease experts was established from Australia, France, Italy, the Netherlands, Norway, the UK, Spain, and Sweden. An enhanced asthma review service was drawn up and implemented by trained health care practitioners in participating centers in each country. The face-to-face review includes questionnaires collecting patient-reported and medical professional-reported outcomes; assessments on current asthma control (including factors that may impact on asthma control as outlined in Global Initiative for Asthma [GINA], British Thoracic Society/Scottish Intercollegiate Guidelines Network, and other relevant guidelines); and a structured inhaler technique assessment. Results Between June 2011 and December 2014, more than 5,000 patients have undergone respiratory consultations by trained health care practitioners in the eight participating countries. Improvements to patient care in the form of management and therapy recommendations in-line with GINA and IPCRG asthma control recommendations are returned to the clinician for consideration (example shown in Table 1). Patients also receive appropriate inhaler training and lifestyle advice following the review. The questionnaire and inhaler assessment data are recorded, anonymized and fed into a central database to enable analyses of outcomes at both a national and international scale. Conclusion iHARP is a global initiative that has been set up to improve asthma patient care, in particular by enhancing patient engagement through face-to-face respiratory reviews carried out by trained health care practitioners. In the future this service will be improved upon by i) extending this service to not only include patients with moderate-severe asthma; ii) simplifying data capture by reducing the information collected and doing so exclusively via a web enabled tool; and iii) refining risk prediction tools following results obtained from recent Respiratory Effectiveness Group studies. Further work will look at implementation of the recommendations and their impact on outcomes, starting in the UK. Patient and health care practitioner reported outcomes may also be further analyzed to improve our understanding of reasons for poor control in patients with asthma., Background Serious inhaler use errors can impair drug delivery to the lungs and have a negative impact on asthma and COPD outcomes. Few real-life studies have evaluated the prevalence of serious errors and the ease with which patients learn correct inhaler technique with different dry powder inhalers. Aim The HI-TEC study aimed to determine the ease of effective use of different inhalers by assessing the proportion of patients who made serious inhaler use errors with PulmoJet® as compared with two other dry powder inhalers (Diskus and Turbuhaler®) at their first device training session in a real-life primary care setting. Methods This was a one visit, real-life, prospective, randomized, crossover study. Patients aged ≥18 years with asthma and/or COPD, currently using metered dose inhalers (MDI), Turbuhaler®, or Diskus, were identified from UK primary care practices. Turbuhaler®/MDI patients who had used Diskus, and Diskus patients who had used Turbuhaler® in the past year before enrollment were excluded. Device handling errors (identified from literature and expert group consensus) and patient characteristics data were collected. MDI/Turbuhaler® users were randomized to training on Diskus followed by PulmoJet or vice versa; Diskus users were randomized to training on Turbuhaler® followed by PulmoJet or vice versa. Experienced trained nurse observers evaluated inhaler technique and recorded serious errors, defined as errors that could potentially affect adequate dose delivery to the lungs. Patients’ inhaler technique was evaluated after reading the device patient information leaflet, and for those with errors, again after watching a demonstration video of correct device use. Baseline patient characteristics were compared according to first randomized device for PulmoJet versus Diskus patients, and PulmoJet versus Turbuhaler® patients, using a Student’s t-test, Mann–Whitney U test, Pearson’s χ2 test, or Fisher’s exact test. Non-inferiority based on pre-specified margins, and if shown, superiority of PulmoJet versus the comparator device (Diskus for MDI/Turbuhaler® users, or Turbuhaler® for Diskus users) was assessed. The difference in the proportion of patients making no serious errors on each device was calculated using a conditional logistic regression model to test for non-inferiority (proportion of patients with no errors using PulmoJet should be no more than 10% lower than the proportion of patients with no errors for the comparator device [ie, lower bound of the confidence interval for the difference in proportions >−0.10]). A conditional logistic regression model stratified by patient ID was used to test for superiority (P, Background Global Initiative for Asthma (GINA) guidelines recommend the use of combination inhalers when medium dose of inhaled steroid alone fails to achieve good control of asthma. Combination inhalers currently licensed for asthma include the metered dose inhalers Seretide® Evohaler® and Flutiform®, which can be prescribed over a range of doses. Once asthma has been controlled for 3 months, step-down of therapy is recommended. Unmet research need A study in 202 patients with asthma showed that fluticasone/formoterol combination was as effective as fluticasone/salmeterol, and had a more rapid bronchodilatory effect. However, this study only included patients at low and medium doses, and further studies comparing these combinations at high doses are needed. There are no studies assessing safety of step-down once asthma control has been achieved on high dose fluticasone/formoterol. Research objective To compare the real-life effectiveness of high dose Seretide® 250 Evohaler® (250 mcg fluticasone/25 mcg salmeterol) and Flutiform® 250 (250 mcg fluticasone/10 mcg formoterol) inhalers in managing asthma, and to assess the safety of step-down in patients with controlled asthma. Research approach This is a two-phase, pragmatic, open-label, randomized controlled trial with a planned enrollment of 224 patients from the UK and Ireland (Figure 1). Eligible patients are 18–75 years old, have a diagnosis of asthma, and have been prescribed Seretide® 250 Evohaler® (two puffs twice daily) for at least 6 months. Key exclusion criteria are any chronic respiratory disease other than asthma, uncontrolled asthma according to the GINA criteria, ≥1 asthma exacerbations in the last 3 months or >2 asthma exacerbations in the last year. In Phase 1, patients are randomized 1:2 to Seretide® 250 Evohaler® or Flutiform® 250. The primary outcome is asthma control, which will be assessed using the Asthma Control Questionnaire during the baseline visit and at the 12-week outcome visit. Secondary outcomes include asthma control assessed according to GINA criteria, Mini-Asthma Quality of Life Questionnaire score, Visual Analog Scale test score, spirometry measurements, and number of adverse events. Patients who are randomized to Flutiform® 250 and have 0 exacerbations in Phase 1 will be eligible for Phase 2, where patients will be randomized 1:1 to continue on Flutiform® 250 or to step-down to Flutiform® 125. Identical assessments conducted in Phase 1 will be conducted during the Phase 2 baseline visit, week 4, and week 12. Fractional Exhaled Nitric Oxide (FeNO), a marker of lung inflammation, will be measured at all Phase 2 visits. The aim is to assess whether FeNO could be used as a marker to predict which patients’ dose could be safely stepped down, and to monitor response after step-down. As an additional marker of inflammation, a blood sample will be collected at the baseline visit to assess blood eosinophil counts. Patient recruitment in the UK is ongoing and results from the study are expected by end of 2015., eHealth using Smartphones has the potential to bring a new dimension to education, research, and clinic practice. Never before has an individual been able to carry in their pocket so much information on patients as well as the process and outcomes of care. I wish to update the group on Smartphone COPD eHealth projects including patient carried summaries (patient passports), standing orders and pathways for emergency room/accident and emergency and hospitalization as well as Guideline tools. Data capture for quality management can be greatly simplified bye Tools and cloud databases in real time. We report one use of the GOLD COPD Guideline tools in a real-life office setting to easily characterize a convenience sample of 500 patients with COPD as to their GOLD COPD stages and current use of non-pharmacological and pharmacological treatment. Social media using Facebook and Twitter are under utilized for both health care and patient education. Recently I have hosted two worldwide Twitter #COPDChat sessions. These have had wide reach with around 2.3 million interactions. Sessions can be developed a head of time using services such as Hootsuite, a social media management dashboard., Background COPD exacerbations and admissions continue to rise in certain parts of the UK, despite improved management in primary care and many initiatives in primary and secondary care to reduce them. North Norfolk Clinical Commissioning Group (CCG) which comprises of 19 general practice surgeries has seen an increase in COPD admissions of 30% between the years 2012–2013 and 2013–2014 (figures from the Dr Foster database). The area is largely rural, with elderly residents, and covers approximate 168,000 patients. Methods A previous Respiratory Effectiveness Group1 study has identified patients with COPD who are at risk of one or more exacerbations using a dataset identifiable from routine general practitioner (GP) clinical data. Factors that predicted COPD exacerbations and admissions included, female sex, asthma, eosinophilia (>0.5×10−9/L) in non-smokers, nasal polyps, and CAT score. The CCG has identified a need to focus resources on patients at risk of COPD exacerbations, in order to reduce admissions and as a second priority reduce unnecessary inhaled corticosteroid (ICS) prescribing in patients with COPD who are not at risk of COPD exacerbations. Two lists of patients will be identified from routine GP clinical computer systems, those at risk of two or more COPD exacerbations using the algorithm above (List A) and patients on high dose ICS who are not at risk of two or more COPD exacerbations (List B). Optimum Patient Care will use their interrogation software to identify the patients in the 17 (out of 19) practices who have agreed to take part. Once the lists are identified in the GP practices, mentored clinics using either D Freeman or V Gerrard will take place with three patients from each list. A self-management plan and ideal management pathway have been designed for the at risk patients, and a triple therapy step down protocol for the patients who have been identified as not at risk of two or more exacerbations. Outcome measures COPD admissions from the Dr Foster database, changes in ICS prescribing in the participating practices, patient satisfaction, and a post hoc data extraction via Optimum Patient Care (OPC) will look at COPD exacerbation rates, changes in prescribing, and where possible CAT and MRC scores. Discussion This is very much a pilot study to assess the feasibility of using the OPC risk assessment tool in a real-life setting in rural North Norfolk. There are of course limitations in terms of the a typical nature of the population and the standard of primary care (which is generally felt to be high in this region). If the project is successful it is hoped to extend it to other parts of Norfolk, and to interested counties and CCGs elsewhere in the UK. Abstract presented at Respiratory Effectiveness Group summit June 2014., Background COPD is a very common disease worldwide and causes substantially impaired quality of life and increased risk of premature death. COPD represents a significant burden for the health care systems as well as for the individual patient and their relatives. However the objective direct and indirect costs of patients with COPD and their spouses and the treatment are incompletely described. Aim We conducted this study to evaluate the socioeconomic burden and consequences of COPD in Denmark in the time period from 1998–2010 – both years before and years after COPD-diagnosis has taken place. Methods Using data from the Danish National Patient Registry (1998–2010), 171,557 patients (83,338 men and 88,219 women) were identified with a diagnosis of COPD. We used the International Classification of Diseases-10 diagnosis classification and included patients with the following diagnoses: COPD (J44.0–44.9). Of these 50.3% (86,260) were married or co-lived with a spouse. For every patient (664,821 control citizens in total – 322,233 men and 342,588 women) and for every spouse (346,524 control citizens in total), four age-, sex-, and socioeconomic-matched citizens were randomly selected from the Danish Civil Registration System. Statistics Direct costs were extracted from the Danish Ministry of Health, Danish Medicines Agency and National Health Security and indirect costs were based on data derived from the Coherent Social Statistics. Results After 12 years only 33.1% of the COPD patients were still alive compared to 61.4% of the control citizens. COPD patients and their spouses had significantly higher rates of health-related contact, medication use, unemployment, and increased socioeconomic costs (especially indirect costs). These effects increased with the severity of COPD. The income level of patients with COPD who were employed was lower than that of employed control citizens. The annual excess total direct and indirect costs for patients with COPD were €6,119 before diagnosis and €8,407 after diagnosis compared to control citizens. Patients with COPD received an annual mean excess social transfer income of €1,886 before diagnosis and €652 after diagnosis compared to control citizens. The annual income level of employed spouses of patients with COPD was €2,925 lower than that of employed control citizens before the COPD diagnosis and €1,454 after the COPD diagnosis. The annual mean excess health-related cost for each spouse of a patient with COPD was €3,182 before the COPD diagnosis and €1,820 after the COPD diagnosis compared to control citizens. Spouses of patients with COPD received an annual mean excess social transfer income (including public funded sick-pay) of €1,045 before diagnosis and €745 after diagnosis compared to control citizens. These socioeconomic consequences of the patients and the spouses were present even 11 years prior to the first diagnosis in the patients with COPD, and up to 11 years after the diagnosis. Conclusion COPD has major socioeconomic consequences for the individual patient and for society. Mortality and morbidity from COPD is very high and earlier disease detection could have a greater impact on disease complications. For the first time ever the major socioeconomic consequences for the spouses of COPD patients have been demonstrated and need to be addressed in the future., Background Clinical trials have so far failed to identify significant differences in asthma outcomes among the available inhaled corticosteroids (ICS), however extra-fine (EF) particles seem to have a better distribution in the distal lung than standard particles (SP) thereby possibly improving asthma control. Aim The aim of this historic cohort, database study was to compare the effectiveness (in terms of asthma control) of initiating ICS therapy as either EF (beclomethasone di-propionate and ciclesonide) or SP-ICS (fluticasone propionate and non-EF- beclomethasone di-propionate) for patients receiving treatment for asthma in the Netherlands. Methods Data were obtained from the PHARMO Database Network, comprising pharmacy and hospital discharge records for approximately 20% of the Dutch population. All the records between January 1998 and December 2012 were considered. The study population included patients aged 12–60 years with a history of ≥2 prescriptions for asthma therapy and receiving first prescription of ICS treatment as either EF or SP-ICS. The study period was 1 year before (baseline) and 1 year after (outcome) treatment initiation. Patients with potential chronic obstructive pulmonary disease (ie, those over 60 years old) were excluded. However those prescribed long-acting muscarinic antagonists were not excluded and comprised 1.8% of the total population. Patients were matched (1:1) on key baseline characteristics (t-test/chi-square test, P, Singapore has a largely walk-in, fee-for service, dual public and private primary health care system to manage the health and diseases of its 5.47 million population. As a Joint Commission International (JCI) accredited primary health care institution and an Accreditation Council for Graduate Medical Education (ACGME) certified Family Medicine training center, SingHealth Polyclinics (SHP) comprise of nine public polyclinics in Singapore and managed 1.73 million patient visits in 2013. To cater to this massive patient load, SHP adopts the Chronic Care Model to optimize its service delivery. Clinical information system, delivery system re-design, self-management, and decision support are key pillars in its framework of care provision. As one of the health care institutions within the SingHealth Regional Health System, SHP adopts its common Outpatient Administrative System for patient billing and other business transactions, as well as the Allscript electronic medical record system. Patients’ visit information is captured at all service points in each polyclinic, from the queue system on their arrival to other service information such as appointment for continuity of care, referral to secondary or tertiary care, and itemized billing before departure. Clinical data, including laboratory and radiological investigations, in-house prescriptions are recorded in the Polyclinic Patient Information System (PPIS). Delivery system re-design at SHP in the past 5 years has facilitated data collection, such as the establishment of health monitoring stations in every polyclinic which are operated by paramedical workers to monitor patients’ clinical parameters such as weight, body mass index, blood pressure, and clinical assessment using Asthma Control Test. Decision support for its health care staff is incorporated into selected chronic disease management modules in the PPIS, such as cardiovascular risk assessment and reminders for its staff to offer smoking cessation advice and recommend preventive measures such as influenza vaccination for at risk patients. SHP doctors and nurses also routinely advocate self-care for patients with chronic diseases and leverage on PPIS to print out patient education material to reinforce self-management, including copies of personalized asthma and COPD action plans for patients with these diseases. The clinical, service, socioeconomic databases in SHP, linked by unique patients’ identification numbers, offer vast opportunities for real time population based research. Within the context of a developed island state populated by multi-ethnic Asian communities, the data provide potential answers to important clinical questions relating to epidemiology; disease burden and prevention; health care service access, quality, utilization and expenditure; trend in drug prescriptions and issues at the primary and secondary health care interface. Database research is expected to escalate with the proposed integration of the Outpatient Administrative System, PPIS, and Allscript databases to form the SHP data warehouse. The SHP Department of Research intends to leverage the establishment of this combined database to spearhead its signature research program, especially in the field of chronic disease management and to use it to test innovations in primary care. The research department will also tap on the expanding pool of well-trained family physicians, nurse educators, advanced practice nurses, and pharmacists within SHP to use the data warehouse to advance the frontier of family medicine via research, which is a key mission of the institution. The institution governance policy dictates that database access is restricted to SHP employees, and current manpower to extricate the data is limited within the research department. Training the research support team to navigate the new data warehouse system will also be a prerequisite. Budget has to be allocated to engage the system developer to provide the relevant staff training. A system of data quality audit and analysis of the data mining processes and pathways need to be established to ensure data accuracy and efficient use of the databases., Objective To present United States observational databases and their use in asthma applications. Approach I will discuss US databases that my colleagues and I have used to address asthma outcomes research questions. Examples will include: large-scale administrative claims databases (such as PharMetrics® or MarketScan®); a registry of severe or difficult-to-treat asthma (The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens); and The Medical Expenditures Panel Survey. The applications, findings, and pros and cons of various databases will be discussed. Discussion Large-scale claims databases are able to address various clinical and health economic questions using large number of records, but comparative questions can be confounded by unmeasured indication or severity. Registries are often built for research purposes and therefore are fit for purpose. Self-reported outcomes, registry ownership, and loss of follow-up can be limitations of registries. US panel survey databases are representative, include detailed socioeconomic information, and contain survey weights to make inferences about the population, but are limited based on the self- or physician-reported data that are surveyed (ie, difficult to do comparative-effectiveness studies). Merging the positive attributes of different data sources like administrative claims and an electronic health record can support many unanswered and impactful research questions., Background Treatment for COPD is tailored based on severity and clinical characteristics. Prescription treatment patterns in COPD patients in primary care may differ from guidelines’ recommendations. Aim To describe the adequacy of treatment prescribed in the newly diagnosed COPD patients according to severity. Methods Epidemiological study with data obtained from the Information System for Development in Research in Primary Care, a population database that contains information of 5.8 million inhabitants (80% of Catalonia’s population). Newly diagnosed COPD patients in the years 2007–2012 were identified through a diagnostic algorithm, and patients with a diagnostic spirometry were included and classified based on GOLD severity stages. Information about the initial treatment patterns was collected. No information regarding mMRC or CAT was available but previous diagnosis of asthma and exacerbations during the previous year were collected. Results Data from 15,312 patients were analyzed. At the time of diagnosis patients were classified as GOLD 1 (13.9%), GOLD 2 (55.2%), GOLD 3 (26%) or GOLD 4 (4.8%). The frequency of patients with a previous diagnosis of asthma or frequent exacerbations was similar between groups (up to 6.6% of patients with previous asthma and 24.5% of frequent exacerbations). Regarding treatment, milder patients were more likely to receive short-acting bronchodilators in monotherapy (21% of patients in GOLD 1 versus 14.8% in GOLD 4) or no treatment after diagnosis (38.7% GOLD 1 versus 13.6% GOLD 4) while patients in GOLD 4 received triple therapy more frequently compared to GOLD 1 (36.6% versus 5.7%). Few patients were treated with double therapy consisting of long-acting β-agonist + long-acting muscarinic antagonists (from 1.6% patients in GOLD 1 to 4% in GOLD 3). The percentage of patients treated with inhaled corticosteroid was higher in the severe groups (28.3%, 37.3%, 51.3%, 59.3% for GOLD 1 to 4 respectively). Conclusion Despite guidelines’ recommendations some GOLD 4 patients are still receiving only short-acting bronchodilator treatment, or no treatment at all after diagnosis. Inhaled corticosteroids are frequently prescribed, especially for severe patients irrespective of their previous history of asthma or number of exacerbations. Study funded by Novartis Spain., Background AAT deficiency (AATD) remains an underdiagnosed condition despite the initiatives developed to increase the awareness in Spain. Underdiagnosis is a challenge particularly for primary care physicians who attend most COPD patients. Aim The objective of this study was to describe the current situation of the diagnosis of AATD in primary care in Catalonia, Spain, an area with 7.5 million inhabitants. Methods This was a population-based, epidemiological study with data obtained from the Information System for Development in Research in Primary Care, a database that contains information of 5.8 million people (80% of Catalonia’s population). We evaluated the number of AAT determinations performed in Primary Care in two periods (2007–2008; 2011–2012) and characterized tested individuals in terms of their demographic and clinical characteristics and their medical visits in the following 6 months, stratified by AAT level. Results During these two periods, 12,409 determinations of serum AAT were performed (1,335 [10.8%] in children), with no significant differences in the number of determinations performed per year. Mean age was 52.6 (16.3) years and 4.6 (standard deviation =4.1) years in children. Among adults, 37.1% were smokers of former smokers. As a plausible indication for AAT determination, 3,195 (28.9%) of adults and 393 (29.4%) of children had a previous diagnosis of a disease related to AATD (in adults: COPD 13.7%, liver disease 8.4%, and in children: asthma 22.3% and liver disease 0.5%). In total, 663 (5.3%) individuals had an intermediate AATD (50 to 100 mg/dL), while 24 (0.2%) had a severe deficiency (, Background Randomized controlled trials suggested that efficacy of fluticasone-propionate/salmeterol (FP/SAL) is not significantly different from fluticasone-propionate/formoterol (FP/FOR). FP/FOR had a lower plume velocity and longer plume duration than FP/SAL, which may be helpful in overcoming poor inhaler technique. In addition, it contains a fast-acting long-acting β-agonist, formoterol, which might encourage better real-life patient adherence. Aim To evaluate non-inferiority in effectiveness (in terms of no severe exacerbations [asthma-related inpatient or emergency room attendance, or acute courses of oral corticosteroids]) in patients with asthma changing from FP/SAL to FP/FOR at the same inhaled corticosteroid (ICS) dose. Methods A historic, observational study using Optimum Patient Care Research Database comprising of 1 year before (baseline) and 1 year after (outcome) first prescription for FP/FOR. Patients (aged 12–80 years), with diagnostic code and/or ≥2 prescriptions for asthma therapy, ≥1 FP/SAL prescription during baseline period and ≥2 FP/FOR prescriptions (including first prescription) during outcome period were included. Patients with other chronic respiratory disease, maintenance oral steroid therapy during baseline, or multiple ICS/long-acting β-agonist combination therapies were excluded. Summary statistics of demographics and disease characteristics were evaluated. Primary outcome was to evaluate non-inferiority in effectiveness (no severe exacerbations) of FP/FOR versus (vs) FP/SAL using conditional logistic regression. The secondary outcomes included comparison of baseline vs outcome composite asthma proxy control (defined as absence of severe exacerbations and/or lower respiratory tract infection consultations leading to prescription for antibiotics), ICS and short-acting β-agonist daily dose (average number of prescriptions over outcome year), adherence to ICS and consultations. ICS doses: beclomethasone-equivalent (BDP-eqv). Comparative statistics were carried out using either Wilcoxon signed rank test, marginal homogeneity test or McNemar’s test as appropriate. Statistically significant results were defined as P, Background Tiotropium was the first approved long-acting muscarinic antagonist (LAMA) as maintenance treatment for COPD. Aclidinium bromide is another LAMA approved in the UK in October 2012. Aim To characterize UK patients with COPD changing therapy from tiotropium to aclidinium bromide and assess the success of the change (defined as at least 70% of these patients having a repeat prescription for aclidinium bromide 6 months following the change). Methods Observational historical cohort study of UK primary care patients from the Optimum Patient Care Research Database changing their LAMA therapy from tiotropium to aclidinium bromide. Eligible patients had a COPD diagnosis and >2 prescriptions for COPD therapy (≥ for tiotropium) in the baseline year before their first aclidinium bromide prescription (defined as the index date). All patients were aged at least 40 years on the index date and had a prescription for any LAMA therapy during the 6-month outcome period following the index date. The primary outcome was “change success” defined as ≥70% of patients with ≥1 prescription for aclidinium bromide during the 6 months following the index date (not including first prescription). Patient characteristics during the baseline year before the first aclidinium bromide prescription were analyzed; comorbid asthma was defined as having a diagnostic asthma code for unresolved asthma. Exacerbations were defined as COPD-related hospital admission/attendance or use of acute oral steroids or any antibiotic prescription for lower respiratory tract infections. Results Change success has been achieved as 87.7% of the patients had at least one further aclidinium bromide prescription 6 months following therapy change. Of all patients prescribed aclidinium bromide, 28.3% also had a prescription for tiotropium during the outcome period. Aclidium bromide, only, was prescribed in 79.2% of patients. See Table 1 for a summary of patients’ demographic and clinical characteristics. Conclusion The switch from tiotropium to aclidinium bromide had a success rate of 87.7%, exceeding the predefined rate of 70%., Background Long-term adherence to inhaled corticosteroids (ICS) in asthma treatment is often low. Observational studies are best suited to assess adherence patterns in daily clinical practice, unlike data from clinical trials in which high adherence is systematically encouraged. Many methods for computing adherence from medical records do not reflect variation in adherence patterns specific to long-term ICS use. Most methods extract a single medication possession ratio irrespective of whether patients discontinued treatment or not. Other methods assess persistence/discontinuation from gaps in drug supply. Theoretical consensus on adherence recommends assessing implementation and persistence separately and considering temporal variations. Moreover, various analytical choices may influence estimates. Aim To assess longitudinal variation in ICS adherence in asthma, using primary care prescription records in the UK. Methods A retrospective observational study was conducted using prescription records in the Optimum Patient Care Research Database between 1987 and 2012. All patients with at least one ICS prescription and 3 years of continuous data were identified. The date of the first ICS prescription was the index date (ID), 1 year prior to ID as baseline period, and 2 years after ID as follow-up. Additional inclusion criteria were: physician-diagnosed asthma at least 1 year prior to ID, age ≥6 years at ID, receiving first ICS prescription at ID and ≥2 prescriptions for ICS and/or short-acting β-agonist at different dates in each follow-up year. Adherence was calculated from prescription records. First, treatment episodes of ICS were computed under three permissible gap conditions (30, 90, and 182 days). Subsequently, medication possession ratios were calculated within treatment episodes for four time interval conditions (6-month, 8-month, 1-year and 2-year intervals), using two different methods (continuous multiple-interval measures of medication availability [CMA]4 and CMA7). The difference between both methods involves handling of drug use data prior to the relevant observation window: in CMA4 this information is ignored, whereas in CMA7 the carry-over is incorporated in the calculation. Differences between methods and between time windows were assessed. Results From 27,185 patients starting ICS identified, 13,263 were excluded (data errors, no asthma diagnosis, missing dosage instructions), leaving 13,922 patients for analysis. Included patients had similar socio-demographic and clinical data to those excluded. Mean age was 39 years (standard deviation 20.2) and 51.3% were women. The prevalence of short-acting β-agonist use during the baseline period was 54.8%, while use of oral glucocorticoids and antibiotics was 8.9%, and 31.8%, respectively. Within treatment episodes (allowing a 90-day permissible gap), ICS adherence ranged from 14.4%–100% for the 2-year follow-up period (mean 88.9%, standard deviation 12.9). Adherence varied slightly under different conditions for permissible gaps, time intervals, and CMA method (Table 1). Conclusion ICS-adherence was higher compared to previous studies, which possibly can be explained by the inclusion criteria applied. Varying the permissible gap when constructing treatment episodes impacted adherence, as expected, with a smaller gap resulting in a higher adherence. When comparing the different CMA methods, differences in mean adherence were relatively small, although dichotomizing adherence at 80% showed some more impact. The findings highlight the importance of conceptually-sound assessments of adherence and careful and transparent analysis choices., In order to facilitate high-quality primary care for several chronic conditions (COPD, diabetes, cardiovascular disease, mental disease), regional “chronic care groups” of general practices have been initiated in the Netherlands in the past ∼10 years. The general practices that participate in these chronic care groups have agreed on the use of standardized procedures and formats to record relevant disease-specific information (including spirometry test results and short questionnaires like the Clinical COPD Questionnaire and Medical Research Council scale) that is used to direct (primary) care and to provide accountability towards health insurance companies for reimbursement. Primary care diagnostic centers and pharmacies support general practitioners in their chronic care for COPD and asthma patients. In addition to the “routine” data sources, practice-based networks that are organized by several academic general practice departments in the country have proved to be very valuable when it comes to prospectively collecting specific additional disease-related data (eg, details of exacerbations, co-morbidity, health status), on top of routinely recorded information. I will present some examples of primary care databases that have or can be used to address clinical questions about COPD and/or asthma, either on their own or by linkage to data from other sources., The New England Journal of Medicine (NEJM) is arguably the most influential journal in the field of clinical medicine. With a current impact factor of 54.42, clinical researchers from around the world would hope to get their papers published in this journal for a variety of reasons. With more than 15,000 submissions every year, only about 200 papers get published. To maintain the leading position among the medical journals, NEJM likes to publish the “first” and the “best”. Studies that provide new directions for treating diseases or better understanding of a condition have a good chance of success. More than one third of the submitted papers belong to the category of clinical trials. Like all other top journals, the review process at NEJM is a very serious business. Reviewers are there to evaluate the papers but the decision is up to the editors. It is not uncommon that papers are rejected after a couple of rounds of revisions. Unlike randomized controlled trials, one of the most important factors that affect acceptability of real world papers is that many reviewers are not familiar with real world pragmatic trials. This factor very often led to poor reviews of the papers. For papers published in NEJM, a reasonable proportion was rated as below average but still get published. If your paper answers a very important clinical question, and your data are informative in providing a novel angle in the management of a respiratory condition, the NEJM will certainly be interested. With all your hard work, we hope to see more real world studies published in NEJM to inform doctors all over the world.
Published: 2015

3. Healthcare Resource Utilization Associated with Intermittent Oral Corticosteroid Prescribing Patterns in Asthma.

Author: Tran TN, Heatley H, Bourdin A, Menzies-Gow A, Jackson DJ, Maslova E, Chapaneri J, Henley W, Carter V, Chan JSK, Ariti C, Haughney J, and Price D
Abstract: Purpose: Oral corticosteroid (OCS) use for asthma is associated with considerable healthcare resource utilization (HCRU) and costs. However, no study has investigated this in relation to patterns of intermittent OCS prescription., Methods: This historical UK cohort study used primary care medical records, linked to Hospital Episode Statistics, from 2008 to 2019, of patients (≥4 years old) with asthma prescribed intermittent OCS. Patients were categorized by OCS prescribing pattern (one-off [single], less frequent [≥90-day gap] and frequent [<90-day gap]) and matched 1:1 (by sex, age and index date) with people never prescribed OCS with/without asthma. HCRU (reported as episodes, except for length of hospital stay [days] and any prescription [records]) and associated costs were compared between intermittent OCS and non-OCS cohorts, and among intermittent OCS prescribing patterns., Results: Of 149,191 eligible patients, 50.3% had one-off, 27.4% less frequent, and 22.3% frequent intermittent OCS prescribing patterns. Annualized non-respiratory HCRU rates were greater in the intermittent OCS versus non-OCS cohorts for GP visits (5.93 vs 4.70 episodes, p < 0.0001), hospital admissions (0.24 vs 0.16 episodes, p < 0.0001), and length of stay (1.87 vs 1.58 days, p < 0.0001). In the intermittent OCS cohort, rates were highest in the frequent prescribing group for GP visits (7.49 episodes; p < 0.0001 vs one-off), length of stay (2.15 days; p < 0.0001) and any prescription including OCS (25.22 prescriptions; p < 0.0001). Mean per-patient non-respiratory related and all-cause HCRU-related costs were higher with intermittent OCS than no OCS (£3902 vs £2722 and £8623 vs £4929, respectively), as were mean annualized costs (£565 vs £313 and £1526 vs £634, respectively). A dose-response relationship existed; HCRU-related costs were highest in the frequent prescribing cohort (p < 0.0001)., Conclusion: Intermittent OCS use and more frequent intermittent OCS prescription patterns were associated with increased HCRU and associated costs. Improved asthma management is needed to reduce reliance on intermittent OCS in primary care., Competing Interests: CA, HH, JSKC, VC and WH are employees of Observational and Pragmatic Research Institute, Singapore, who conducted this study, funded by AstraZeneca. WH reports grants from AstraZeneca, during the conduct of the study; grants from Chiesi Pharmaceuticals, outside the submitted work. VC works for The Optimum Patient Care Global who received funding/grant for the study. DP has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi Pharmaceuticals, Mylan, Novartis, Regeneron, Sanofi. Thermofisher Scientific and Viatris; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi Pharmaceuticals, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Medscape, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Teva Pharmaceuticals, Theravance Biopharma, Viatris and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi, Theravance, UK National Health Service and Viatris; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Inside Practice, Kyorin, Medscape, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi, Teva Pharmaceuticals and Viatris; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Teva Pharmaceuticals and Thermofisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. JC, EM, AMG, and TNT are employees of, and own stock in, AstraZeneca. JH reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Circassia and Teva unrelated to the conduct of the study. AB has received consultancy fees and speakers’ fees from of AstraZeneca, Amgen, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi and Regeneron, and research grants from AstraZeneca, Boehringer Ingelheim and GlaxoSmithKline. AMG is an employee of, and owns stock in, AstraZeneca and has received grants, advisory board fees, lecture fees and consulting fees from AstraZeneca; advisory board fees from GlaxoSmithKline; advisory board fees and lecture fees from Novartis; advisory board fees, lecture fees and travel expenses from Teva; advisory board fees from Regeneron; and advisory board fees, lecture fees and consulting fees from Sanofi. DJJ has received consultancy fees and speakers’ fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Sanofi and Regeneron, and research grants from AstraZeneca., (© 2024 Tran et al.)
Published: 2024
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4. Budesonide/Glycopyrrolate/Formoterol for the Management of COPD in a UK Primary Care Population: Real-World Use and Early Medication Success.

Author: Müllerová H, Chan JSK, Heatley H, Carter V, Townend J, Skinner D, Franzén S, Marshall J, and Price D
Subjects: Humans, Male, Female, Aged, Treatment Outcome, Middle Aged, Time Factors, United Kingdom, Budesonide, Formoterol Fumarate Drug Combination administration & dosage, Budesonide, Formoterol Fumarate Drug Combination adverse effects, Budesonide, Formoterol Fumarate Drug Combination therapeutic use, Lung physiopathology, Lung drug effects, Muscarinic Antagonists administration & dosage, Muscarinic Antagonists adverse effects, Drug Combinations, Retrospective Studies, Glucocorticoids administration & dosage, Glucocorticoids adverse effects, Aged, 80 and over, Pulmonary Disease, Chronic Obstructive drug therapy, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive physiopathology, Primary Health Care, Bronchodilator Agents administration & dosage, Bronchodilator Agents adverse effects, Adrenergic beta-2 Receptor Agonists administration & dosage, Adrenergic beta-2 Receptor Agonists adverse effects, Glycopyrrolate administration & dosage, Glycopyrrolate adverse effects, Databases, Factual
Abstract: Purpose: Real-life research is needed to evaluate the effectiveness of budesonide/glycopyrrolate/formoterol (BGF) in routine COPD primary care management. We assessed the frequency of medication success among patients with COPD who initiated BGF using real-world data., Patients and Methods: Patients with a recorded diagnostic COPD code who started BGF with ≥2 prescriptions within 90-days were identified in the UK Optimum Patient Care Research Database and followed from first prescription until censoring at the end of follow-up (180-days), death, leaving database or end of data at 24/10/2022. The primary outcome was medication success at 90-days post-BGF initiation, defined as no major cardiac or respiratory event (ie no complicated COPD exacerbation, hospitalization for any respiratory event, myocardial infarction, new/hospitalized heart failure, and death) and no incidence of pneumonia. Medication success was also assessed at 180-days post-BGF initiation. Overall real-life medication success was claimed if the lower 95% confidence interval (CI) for the proportion of patients meeting the primary outcome was ≥70% (defined a priori)., Results: Two hundred eighty-five patients were included. Prior to BGF initiation, these patients often had severe airflow obstruction (mean ppFEV 1 : 54.5%), were highly symptomatic (mMRC ≥2: 77.9% (n = 205/263); mean CAT score: 21.7 (SD 7.8)), with evidence of short-acting β 2 -agonist (SABA) over-use (≥3 inhalers/year: 62.1%, n=179/285), repeat OCS prescriptions (≥2 courses/year: 33.0%, n = 95/285) and multiple primary care consultations (≥2 visits/year: 61.1%, n = 174/285). Overall, 39.6% of patients (n = 113/285) switched from previous triple therapies. Real-life medication success was achieved by 96.5% of patients (n = 275/285 [95% CI: 93.6, 98.3]) during 90-days treatment with BGF and by 91.8% (n = 169/184 [95% CI: 86.9, 95.4]) of patients at 180-days. The prescribed daily dose of SABA remained stable over the study period., Conclusion: The majority of patients initiating BGF experienced real-life medication success reflecting the absence of severe cardiopulmonary events. These benefits were apparent after 90-days of treatment and sustained over 180-days., Competing Interests: Hana Müllerová, Stefan Franzén, Johann Castaneda, and Jonathan Marshall are employees of, and own stock in, AstraZeneca. Jeffrey Shi Kai Chan, Heath Heatley, Victoria Carter, John Townend, and Derek Skinner are employees of Observational and Pragmatic Research Institute. David Price has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Viatris, Teva Pharmaceuticals; consultancy agreements with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Viatris, Teva Pharmaceuticals; consultancy and lecture fees from Medscape, Inside Practice paid to Observational and Pragmatic Research Institute; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Chiesi, Viatris, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Viatris, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme, Teva Pharmaceuticals; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Novartis, Teva Pharmaceuticals; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. The authors report no other conflicts of interest in this work., (© 2024 Müllerová et al.)
Published: 2024
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5. Risk of Pneumonia in Patients with COPD Initiating Fixed Dose Inhaled Corticosteroid (ICS) / Long-Acting Bronchodilator (LABD) Formulations Containing Extrafine Beclometasone Dipropionate versus Patients Initiating LABD Without ICS.

Author: Price D, Henley W, Cançado JED, Fabbri LM, Kerstjens HAM, Papi A, Roche N, Şen E, Singh D, Vogelmeier CF, Nudo E, Carter V, Skinner D, Vella R, Soriano JB, Kots M, and Georges G
Abstract: Background: Combined ICS and long-acting bronchodilators (LABD) more effectively reduce COPD exacerbations than LABD therapy alone. Corticosteroid-related adverse effects, including pneumonia, limit ICS use. Previous data suggest this risk is lower for extrafine beclometasone (ef-BDP). We compared pneumonia risk among new users of fixed dose ICS/LABD formulations containing ef-BDP, versus patients initiating LABD without any ICS., Methods: A propensity-matched historical cohort study design used data from OPCRD. COPD patients with ≥1 year of continuous data who initiated LABD or ICS/LABD formulations containing ef-BDP were matched. Primary outcome was time to pneumonia event, as treated, using either sensitive (physician diagnosed) or specific (physician diagnosed and x-ray or hospital admission confirmed) definitions, with non-inferiority boundary of 15%., Results: 23,898 COPD patients were matched, who were 68±11 years, 54.3% male and 56% current-smokers, while 43% were former-smokers. Initiation of ef-BDP/LABD was not associated with an increased risk of pneumonia versus LABD, for either a sensitive 0.89 (0.78-1.02), P = 0.08 or a specific 0.91 (0.78-1.05), P = 0.18 definition of pneumonia. The probability of remaining pneumonia free 1-year after ef-BDP/LABD was 98.4%, which was comparable to LABD at 97.7%, and was sustained up to 6 years of observation; non-inferiority criterion was met for both definitions. Initiation of ef-BDP/LABD was also associated with a reduced risk of developing LRTIs in the propensity matched cohort., Conclusion: Risk of pneumonia when using ICS for the management of COPD reported in several randomised controlled trials may not be relevant with ef-BDP in a diverse real-world clinical population., Competing Interests: Leonardo M. Fabbri reports lecture fees and/or consultancies from Alfasigma, AstraZeneca, Chiesi, Boehringer Ingelheim, GlaxoSmithKline, Lusofarmaco, Merck, Novartis, Zambon, and Verona Pharma. Huib AM Kerstjens reports grants and consultancy/advisory board participation from/for AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, and Novartis, all outside the submitted work. All were paid to his institution. Alberto Papi is on the boards for and has received research and travel support and consultancy and lecture fees from Chiesi Farmaceutici, AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Merck Sharp & Dohme, Takeda, Mundipharma Research Limited, and Teva; reports grants from Chiesi, AstraZeneca, GlaxoSmithKline and Sanofi; personal fees from Iqvia, Avillion, Elpen Pharmaceuticals, Moderna, Edmond Pharm; has received lecture fees and travel support from Menarini, Novartis, and Zambon; is on the boards for and has received lecture fees and travel support from Pfizer and has received research support from Sanofi. Nicolas Roche reports research grants and fees from Boehringer Ingelheim, Novartis, Pfizer, GSK and fees for advisory boards, consultation, education, presentations from Austral, Biosency, MSD, AstraZeneca, Chiesi, Menarini, MSD, Nuvaira, Sanofi, and Zambon. Dave Singh has received personal fees from Aerogen, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, CSL Behring, Epiendo, Genentech, GlaxoSmithKline, Glenmark, Gossamerbio, Kinaset, Menarini, Novartis, Orion, Pulmatrix, Sanofi, Teva, Theravance and Verona. Claus F Vogelmeier gave presentations at symposia and/or served on scientific advisory boards sponsored by Aerogen, AstraZeneca, Boehringer Ingelheim, CSL Behring, Chiesi, GlaxoSmithKline, Grifols, Insmed, Menarini, Novartis, Nuvaira, MedUpdate, Roche, and Sanofi. Elif Şen reports is a full-time employee of Chiesi Farmaceutici S.p.A. Joan B Soriano reports grants from Novartis and personal fees for lecturing with AstraZeneca, Chiesi, Grifols, GSK, Novartis, Pfizer, Teva, and Zambon. José Eduardo Delfini Cançado reports grants and personal fees from Aché, AstraZeneca, Boehringer Ingelheim, Chiesi, Eurofarma, GlaxoSmithkline, Glenmarkpharma, Novartis, Sanofi and Zambon. Elena Nudo and George Georges are employees of Chiesi Farmaceutici, S.p.A. Maxim Kots is a full time Chiesi Farmaceutici employee. William Henley, Derek Skinner, Rebecca Vella and Victoria Carter are employees of Observational and Pragmatic Research Institute who conducted this study. David Price has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Viatris, Teva Pharmaceuticals; consultancy agreements with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Viatris, Teva Pharmaceuticals; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Chiesi, Viatris, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, and UK National Health Service; grants from Boehringer Ingelheim; grants, personal fees from Theravance; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Viatris, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme, Teva Pharmaceuticals; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Novartis, Teva Pharmaceuticals; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. The authors report no other conflicts of interest in this work., (© 2024 Price et al.)
Published: 2024
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6. A Long-Term Study of Adverse Outcomes Associated With Oral Corticosteroid Use in COPD.

Author: Tse G, Emmanuel B, Ariti C, Bafadhel M, Papi A, Carter V, Zhou J, Skinner D, Xu X, Müllerová H, and Price D
Subjects: Humans, Cohort Studies, Adrenal Cortex Hormones adverse effects, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive drug therapy, Pulmonary Disease, Chronic Obstructive chemically induced, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 chemically induced, Cerebrovascular Disorders
Abstract: Background: Oral corticosteroids (OCS) are often prescribed for chronic obstructive pulmonary disease (COPD) exacerbations., Methods: This observational, individually matched historical cohort study used electronic medical records (1987-2019) from the UK Clinical Practice Research Datalink linked to English Hospital Episode Statistics (HES) to evaluate adverse outcomes in patients with COPD who used OCS (OCS cohort) and those not exposed to OCS (non-OCS cohort). Risk of 17 adverse outcomes was estimated using proportional hazard regression., Results: Of 323,722 patients, 106,775 (33.0%) had COPD-related OCS prescriptions. Of the 106,775 patients in the overall cohort, 58,955 had HES linkage and were eligible for inclusion in the OCS cohort. The individual matching process identified 53,299 pairs of patients to form the OCS and non-OCS cohorts. Median follow-up post-index was 6.9 years (OCS cohort) and 5.4 years (non-OCS cohort). Adjusted risk of multiple adverse outcomes was higher for the OCS cohort versus the non-OCS cohort, including osteoporosis with/without fractures (adjusted hazard ratio [aHR] 1.80; 95% confidence interval [CI] 1.70-1.92), type 2 diabetes mellitus (aHR 1.44; 95% CI 1.37-1.51), cardiovascular/cerebrovascular disease (aHR 1.26; 95% CI 1.21-1.30), and all-cause mortality (aHR 1.04; 95% CI 1.02-1.07). In the OCS cohort, risk of most adverse outcomes increased with increasing categorized cumulative OCS dose. For example, risk of cardiovascular/cerebrovascular disease was 34% higher in the 1.0-<2.5 g group versus the <0.5 g group (HR 1.34; 95% CI 1.26-1.42)., Conclusion: Any OCS use was associated with higher risk of adverse outcomes in patients with COPD, with risk generally increasing with greater cumulative OCS dose., Competing Interests: GT and CA are former employees of the Observational and Pragmatic Research Institute (OPRI), which was funded by AstraZeneca to conduct this study. VC, JZ, and DS are employees of OPRI, which was funded by AstraZeneca to conduct this study. BE, XX, and HM are employees of AstraZeneca and hold stock and/or stock options in the company. MB has received research grants to her institution from AstraZeneca; honoraria to her institution from AstraZeneca, Chiesi, and GlaxoSmithKline; and is an advisory board member for Albus Health and ProAxsis. AP has received scientific grants to his institution from Agenzia Italiana del Farmaco (AIFA), AstraZeneca, Chiesi, GlaxoSmithKline, and Sanofi; has received consulting fees from AstraZeneca, Avillion, Chiesi, ELPEN Pharmaceuticals, GlaxoSmithKline, Novartis, and Sanofi; has received payment or honoraria for lectures, presentations, speaker bureaus, or educational events from AstraZeneca, Avillion, Chiesi, Edmond Pharma, ELPEN Pharmaceuticals, Moderna, GlaxoSmithKline, IQVIA, Menarini, Mundipharma, Novartis, Sanofi, and Zambon; and is an advisory board member for AstraZeneca, Avillion, Chiesi, ELPEN Pharmaceuticals, GlaxoSmithKline, IQVIA, MSD, Novartis, and Sanofi. DP is an employee of OPRI, which was funded by AstraZeneca to conduct this study; has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, and Thermo Fisher; has consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON, Fieldwork International, GlaxoSmithKline, Mundipharma, Mylan, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance, and WebMD Global LLC; has received grants and unrestricted funding for investigator-initiated studies (conducted through OPRI) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance, and UK National Health Service; has received payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mundipharma, Mylan, Novartis, Regeneron Pharmaceuticals, and Sanofi Genzyme; has received payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, and Thermo Fisher; has stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of OPRI (Singapore); has a 5% shareholding in Timestamp, which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation Programme and Health Technology Assessment; and has been an expert witness for GlaxoSmithKline. The authors report no other conflicts of interest in this work., (© 2023 Tse et al.)
Published: 2023
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7. Data-Resource Profile: United Kingdom Optimum Patient Care Research Database.

Author: Lynam A, Curtis C, Stanley B, Heatley H, Worthington C, Roberts EJ, Price C, Carter V, Dennis J, McGovern A, and Price D
Abstract: Introduction: Electronic medical records (EMRs) maintained in primary care in the UK and collected and stored in EMR databases offer a world-leading resource for observational clinical research. We aimed to profile one such database: the Optimum Patient Care Research Database (OPCRD)., Methods and Participants: The OPCRD, incepted in 2010, is a growing primary care EMR database collecting data from 992 general practices within the UK. It covers over 16.6 million patients across all four countries within the UK, and is broadly representative of the UK population in terms of age, sex, ethnicity and socio-economic status. Patients have a mean duration of 11.7 years' follow-up (SD 17.50), with a majority having key summary data from birth to last data entry. Data for the OPCRD are collected incrementally monthly and extracted from all of the major clinical software systems used within the UK and across all four coding systems (Read version 2, Read CTV3, SNOMED DM+D and SNOMED CT codes). Via quality-improvement programmes provided to GP surgeries, the OPCRD also includes patient-reported outcomes from a range of disease-specific validated questionnaires, with over 66,000 patient responses on asthma, COPD, and COVID-19. Further, bespoke data collection is possible by working with GPs to collect new research via patient-reported questionnaires., Findings to Date: The OPCRD has contributed to over 96 peer-reviewed research publications since its inception encompassing a broad range of medical conditions, including COVID-19., Conclusion: The OPCRD represents a unique resource with great potential to support epidemiological research, from retrospective observational studies through to embedded cluster-randomised trials. Advantages of the OPCRD over other EMR databases are its large size, UK-wide geographical coverage, the availability of up-to-date patient data from all major GP software systems, and the unique collection of patient-reported information on respiratory health., Competing Interests: A. Lynam, C. Curtis, J. Dennis and A. McGovern are employees of Momentum Data who were unpaid consultants to OPCRD in connection with the development of this manuscript. A. McGovern reports grants from Pfizer, Eli Lilly, AstraZeneca; personal fees from Boehringer Ingelheim, outside the submitted work. E.J Roberts, V. Carter, C. Price, C. Worthington are employees of Optimum Patient Care, UK. H. Heatley and B. Stanley are employees of Observational and Pragmatic Research Institute, Singapore. D. Price has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermofisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Merck, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. The authors report no other conflicts of interest in this work., (© 2023 Lynam et al.)
Published: 2023
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8. Characterization of Patients in the International Severe Asthma Registry with High Steroid Exposure Who Did or Did Not Initiate Biologic Therapy.

Author: Chen W, Sadatsafavi M, Tran TN, Murray RB, Wong CBN, Ali N, Ariti C, Garcia Gil E, Newell A, Alacqua M, Al-Ahmad M, Altraja A, Al-Lehebi R, Bhutani M, Bjermer L, Bjerrum AS, Bourdin A, Bulathsinhala L, von Bülow A, Busby J, Canonica GW, Carter V, Christoff GC, Cosio BG, Costello RW, FitzGerald JM, Fonseca JA, Yoo KH, Heaney LG, Heffler E, Hew M, Hilberg O, Hoyte F, Iwanaga T, Jackson DJ, Jones RC, Koh MS, Kuna P, Larenas-Linnemann D, Lehmann S, Lehtimäki LA, Lyu J, Mahboub B, Maspero J, Menzies-Gow AN, Sirena C, Papadopoulos N, Papaioannou AI, Pérez de Llano L, Perng DW, Peters M, Pfeffer PE, Porsbjerg CM, Popov TA, Rhee CK, Salvi S, Taillé C, Taube C, Torres-Duque CA, Ulrik CS, Ra SW, Wang E, Wechsler ME, and Price DB
Abstract: Background: Many severe asthma patients with high oral corticosteroid exposure (HOCS) often do not initiate biologics despite being eligible. This study aimed to compare the characteristics of severe asthma patients with HOCS who did and did not initiate biologics., Methods: Baseline characteristics of patients with HOCS (long-term maintenance OCS therapy for at least 1 year, or ≥4 courses of steroid bursts in a year) from the International Severe Asthma Registry (ISAR; https://isaregistries.org/), who initiated or did not initiate biologics (anti-lgE, anti-IL5/5R or anti-IL4R), were described at the time of biologic initiation or registry enrolment. Statistical relationships were tested using Pearson's chi-squared tests for categorical variables, and t-tests for continuous variables, adjusting for potential errors in multiple comparisons., Results: Between January 2015 and February 2021, we identified 1412 adult patients with severe asthma from 19 countries that met our inclusion criteria of HOCS, of whom 996 (70.5%) initiated a biologic and 416 (29.5%) did not. The frequency of biologic initiation varied across geographical regions. Those who initiated a biologic were more likely to have higher blood eosinophil count (483 vs 399 cells/µL, p=0.003), serious infections (49.0% vs 13.3%, p<0.001), nasal polyps (35.2% vs 23.6%, p<0.001), airflow limitation (56.8% vs 51.8%, p=0.013), and uncontrolled asthma (80.8% vs 73.2%, p=0.004) despite greater conventional treatment adherence than those who did not start a biologic. Both groups had similar annual asthma exacerbation rates in the previous 12 months (5.7 vs 5.3, p=0.147)., Conclusion: Around one third of severe HOCS asthma patients did not receive biologics despite a similar high burden of asthma exacerbations as those who initiated a biologic therapy. Other disease characteristics such as eosinophilic phenotype, serious infectious events, nasal polyps, airflow limitation and lack of asthma control appear to dictate biologic use., Competing Interests: Mohsen Sadatsafavi has received honoraria from AZ, BI, and GSK for purposes unrelated to the content of this manuscript and has received research funding from AZ and BI directly into his research account from AZ for unrelated projects. Trung N. Tran is an employee of AstraZeneca. AstraZeneca is a co-funder of the International Severe Asthma Registry. Nigel Chong Boon Wong reports grants from Optimum Patient Care Global, grants from AstraZeneca Ltd, during the conduct of the study. Nasloon Ali was an employee of Observational and Pragmatic Research Institute (OPRI) at the time this research was conducted. OPRI conducted this study in collaboration with Optimum Patient Care and AstraZeneca. Con Ariti is an employee of the Observational and Pragmatic Research Institute (OPRI). OPRI conducted this study in collaboration with Optimum Patient Care and AstraZeneca. Esther Garcia Gil was an employee of AstraZeneca at the time this research was conducted. AstraZeneca is a co-funder of the International Severe Asthma Registry. Anthony Newell was an employee of Optimum Patient Care (OPC) at the time this research was conducted. OPC is a co-funder of the International Severe Asthma Registry. Marianna Alacqua was an employee of AstraZeneca at the time this research was conducted. AstraZeneca is a co-funder of the International Severe Asthma Registry. Mona Al-Ahmad has received advisory board and speaker fees from AstraZeneca, Sanofi, Novartis, and GlaxoSmithKline. Alan Altraja has received lecture fees from AstraZeneca, Berlin-Chemie Menarini, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Norameda, Novartis, Orion, Sanofi, and Zentiva; personal fees from Teva, Shire Pharmaceuticals and CSL Behring, sponsorships from AstraZeneca, Berlin-Chemie Menarini, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Norameda, Sanofi, and Novartis; and has been a member of advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi, and Teva. Riyad Al-Lehebi has given lectures at meetings supported by AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Sanofi, reports personal fees from Novartis and participated in advisory board fees from GlaxoSmithKline. Mohit Bhutani: has received advisory board and speaker fees from AstraZeneca, GlaxoSmithKline, Pfizer, Sanofi Genzyme, Covis pharmaceuticals; has been an investigator on clinical trials sponsored by AstraZeneca, GlaxoSmithKline, Sanofi Genzyme, Boehringer Ingelheim Leif Bjermer has (in the last three years) received lecture or advisory board fees from Alk-Abello, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, Sanofi, Genzyme/Regeneron, and Teva. Anne-Sofie Bjerrum has received lecture fees from Astra Zeneca, GlaxoSmithKline, Novartis. Arnaud Bourdin has received industry-sponsored grants from AstraZeneca-MedImmune, Boehringer-Ingelheim, Cephalon/Teva, GlaxoSmithKline, Novartis, Sanofi-Regeneron and consultancies with AstraZeneca-MedImmune, Boehringer-Ingelheim, GlaxoSmithKline, Novartis, Regeneron-Sanofi, Med-in-Cell, Actelion, Merck, Roche, and Chiesi. Lakmini Bulathsinhala is an employee of the Observational and Pragmatic Research Institute (OPRI). OPRI conducted this study in collaboration with Optimum Patient Care and AstraZeneca. Anna von Bülow reports speakers fees and consultancy fees from AstraZeneca, GSK and Novartis, outside the submitted work. She has also attended advisory board for Novartis and AstraZeneca. John Busby reports personal fees from NuvoAir, outside the submitted work. Giorgio Walter Canonica has received research grants, as well as lecture or advisory board fees from A. Menarini, Alk-Albello, Allergy Therapeutics, Anallergo, AstraZeneca, MedImmune, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia, Danone, Faes, Genentech, Guidotti Malesci, GlaxoSmithKline, Hal Allergy, Merck, MSD, Mundipharma, Novartis, Orion, Sanofi Aventis, Sanofi, Genzyme/Regeneron, Stallergenes, UCB Pharma, Uriach Pharma, Teva, Thermo Fisher, and Valeas. Victoria Carter is an employee of Optimum Patient Care, a co-funder of the International Severe Asthma Registry and reports grants from Optimum Patient Care Global, during the conduct of the study Borja G. Cosio declares grants from Chiesi, AstraZeneca, Menarini, Teva and GSK; personal fees for advisory board activities from Chiesi, GSK, Novartis, Sanofi, Menarini, Teva and AstraZeneca; and payment for lectures/speaking engagements from Chiesi, Novartis, GSK, Menarini, Sanofi, Teva and AstraZeneca, outside the submitted work. Richard W. Costello has received honoraria for lectures from Aerogen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Teva. He is a member of advisory boards for GlaxoSmithKline and Novartis, has received grant support from GlaxoSmithKline and Aerogen, has received personal fees from Respirasense, personal fees from PfizerBioNTech, during the conduct of the study and has patents in the use of acoustics in the diagnosis of lung disease, assessment of adherence and prediction of exacerbations, issued to 212. J. Mark FitzGerald reports grants from AstraZeneca, GSK, Sanofi Regeneron, Novartis paid directly to UBC. Personal fees for lectures and attending advisory boards: AstraZeneca, GSK, Sanofi Regeneron, TEVA. João A Fonseca reports grants from or research agreements with AstraZeneca, Mundipharma, Sanofi Regeneron and Novartis. Personal fees for lectures and attending advisory boards: AstraZeneca, GSK, Mundipharma, Novartis, Sanofi Regeneron and TEVA. Liam G. Heaney declares he has received grant funding, participated in advisory boards and given lectures at meetings supported by Amgen, AstraZeneca, Boehringer Ingelheim, Circassia, Evelo Biosciences, Hoffmann la Roche, GlaxoSmithKline, Novartis, Theravance and Teva; he has taken part in asthma clinical trials sponsored by Boehringer Ingelheim, Hoffmann la Roche, and GlaxoSmithKline for which his institution received remuneration; he is the Academic Lead for the Medical Research Council Stratified Medicine UK Consortium in Severe Asthma which involves industrial partnerships with a number of pharmaceutical companies including Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Hoffmann la Roche, and Janssen. Enrico Heffler participates in speaking activities and industry advisory committees for AstraZeneca, Sanofi-Genzyme, GSK, Novartis, Regeneron, Stallergenes-Greer, TEVA, Circassia and Nestlè Purina, grants from AstraZeneca and GSK Mark Hew declares grants and other advisory board fees (made to his institutional employer) from AstraZeneca, GlaxoSmithKline, Novartis, Sanofi, and Seqirus, for unrelated projects. Flavia Hoyte declares honoraria from AstraZeneca. She has been an investigator on clinical trials sponsored by GlaxoSmithKline, Genentech, Teva, Sanofi and National Institute of Allergy and Infectious Diseases (NIAID), for which her institution has received funding. Takashi Iwanaga declares grants from Astellas, Boehringer Ingelheim, Daiichi-Sankyo, Kyorin, MeijiSeika Pharma, Teijin Pharma, Ono, and Taiho, and lecture fees from Kyorin, GlaxoSmithKline, Sanofi and AstraZeneca. David J. Jackson has received advisory board and speaker fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Teva, Napp, Chiesi, Sanofi Regeneron, Novartis and research grant funding from AstraZeneca. Rupert C. Jones declares grants from Astra Zeneca, Glaxo Smith Kline, Novartis OPRI and Teva and personal fees for consultancy, speakers’ fees or travel support from Astra Zeneca, Boehringer Ingelheim, Glaxo Smith Kline, Novartis and OPRI. Mariko Siyue Koh reports grant support from AstraZeneca, and honoraria for lectures and advisory board meetings paid to her hospital (Singapore General Hospital) from GlaxoSmithKline, AstraZeneca, Sanofi and Boehringer Ingelheim, outside the submitted work. Piotr Kuna reports personal fees from Adamed, personal fees from AstraZeneca, personal fees from Berlin Chemie Manarini, personal fees from Boehringer Ingelheim, personal fees from Lekam, personal fees from Novartis, personal fees from Chiesi, personal fees from Polpharma, personal fees from Sanofi, personal fees from Teva, personal fees from Zentiva, personal fees from FAES, personal fees from Glenmark, outside the submitted work Désirée Larenas Linnemann reports speaker or personal fees from ALK, Alakos, Armstrong, AstraZeneca, Boehringer Ingelheim, Chiesi, DBV Technologies, Gossamer, Grunenthal, GSK, Mylan/Viatris, Menarini, MSD, Novartis, Pfizer, Purina institute, Sanofi, Siegfried, UCB, Carnot, Viatris, and grants from Sanofi, AbbVie, ALK, AstraZeneca, Circassia, Chiesi, GSK, Lilly, Novartis, Pfizer, Purina Institute and UCB, outside the submitted work Sverre Lehmann declares receipt of lecture (personal) and advisory board (to employer) fees from AstraZeneca, Boehringer Ingelheim, and Novartis. Lauri A. Lehtimäki declares personal fees for consultancy, lectures and attending advisory boards from ALK, AstraZeneca, Boehringer Ingelheim, Circassia, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, Orion Pharma, Sanofi, and Teva. Juntao Lyu is an employee of Optimum Patient Care (OPC). OPC is a co-funder of the International Severe Asthma Registry. Jorge Maspero reports grants and personal fees from AstraZeneca, Sanofi, Novartis, and GSK, personal fees from IMMUNOTEK, personal fees from SANOFI, outside the submitted work. Andrew N. Menzies-Gow has attended advisory boards for AstraZeneca, GlaxoSmithKline, Novartis, Regeneron, Sanofi and Teva, andhas received speaker fees from AstraZeneca, Novartis, Teva and Sanofi. He has participated in research with AstraZeneca for which his institution has been remunerated and has attended international conferences with Teva. He has had consultancy agreements with AstraZeneca and Sanofi. Nikolaos G. Papadopoulos declares research support from Gerolymatos, Menarini, Nutricia, and Vian; and consultancy/speaker fees from ASIT, AZ, Boehringer Ingelheim, GSK, HAL Allergy, Medscape, Menarini, MSD, Mylan, Novartis, and Nutricia, OM Pharma, Sanofi, and Takeda, grant from Capricare. Andriana I. Papaioannou has received fees and honoraria from Menarini, GSK, Novartis, Elpen, Boehringer Ingelheim, AstraZeneca, and Chiesi. Luis Perez-de-Llano declares non-financial support, personal fees, and grants from Teva, Sanofi and AstraZeneca, Chesi; non-financial support and personal fees from Boehringer Ingelheim, Esteve, GlaxoSmithKline, Mundipharma, and Novartis; personal fees from MSD, TECHDOW PHARMA, Leo-Pharma, GEBRO and GILEAD; non-financial support from Menairi, grants, non-financial support from FAES during the conduct of the study. Diahn-Warng Perng (Steve) received sponsorship to attend or speak at international meetings, honoraria for lecturing or attending advisory boards, and research grants from the following companies: AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Daiichi Sankyo, Shionogi and Orient Pharma Matthew Peters declares personal fees and non-financial support from AstraZeneca and GlaxoSmithKline. Paul E. Pfeffer has attended advisory boards for AstraZeneca, Sanofi and GSK; has given lectures at meetings supported by AstraZeneca and GlaxoSmithKline; has taken part in clinical trials sponsored by AstraZeneca, GlaxoSmithKline, Sanofi and Novartis, for which his institution received remuneration; non-financial support from Chiesi; and has a current research grant funded by GlaxoSmithKline. Celeste M. Porsbjerg has attended advisory boards for AstraZeneca, Novartis, TEVA, and Sanofi-Genzyme; has given lectures at meetings supported by AstraZeneca, Novartis, TEVA, Sanofi-Genzyme, and GlaxoSmithKline; has taken part in clinical trials sponsored by AstraZeneca, Novartis, MSD, Sanofi-Genzyme, GlaxoSmithKline, and Novartis; and has received educational and research grants from AstraZeneca, Novartis, TEVA, GlaxoSmithKline, ALK, and Sanofi-Genzyme. Todor A. Popov declares relevant research support from Novartis and Chiesi Pharma. Chin Kook Rhee declares consultancy and lecture fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mundipharma, MSD, Novartis, Sandoz, Sanofi, Takeda, and Teva-Handok. Sundeep Salvi declares research support and speaker fees from Cipla, Glenmark, GSK Camille Taillé has received lecture or advisory board fees and grants to her institution from AstraZeneca, Sanofi, GlaxoSmithKline, Chiesi and Novartis, for unrelated projects. Carlos A. Torres-Duque has received fees as advisory board participant and/or speaker from AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Novartis, and Sanofi-Aventis; has taken part in clinical trials from AstraZeneca, Novartis and Sanofi-Aventis; has received unrestricted grants for investigator-initiated studies at Fundacion Neumologica Colombiana from AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Grifols and Novartis. Charlotte S. Ulrik has attended advisory boards for AstraZeneca, ALK-Abello, GSK, Boehringer-Ingelheim, Novartis, Chiesi, TEVA, and Sanofi-Genzyme; has given lectures at meetings supported by AstraZeneca, Sandoz, Mundipharma, Chiesi, Boehringer-Ingelheim, Orion Pharma, Novartis, TEVA, Sanofi-Genzyme, and GlaxoSmithKline; has taken part in clinical trials sponsored by AstraZeneca, Novartis, Merck, InsMed, ALK-Abello, Sanofi-Genzyme, GlaxoSmithKline, Boehringer-Ingelheim, Regeneron, Chiesi and Novartis; and has received educational and research grants from AstraZeneca, MundiPharma, Boehringer-Ingelheim, Novartis, TEVA, GlaxoSmithKline and Sanofi-Genzyme; has received personal fees from Pfizer. Seung Won Ra has received lecture fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, and Novartis. Eileen Wang has received honoraria from AstraZeneca, GlaxoSmithKline, Wefight, and Clinical Care Options. She has been an investigator on clinical trials sponsored by AstraZeneca, GlaxoSmithKline, Genentech, Novartis, Teva, and Sanofi, for which her institution has received funding. She has received personal fees from Wefight. Michael E. Wechsler reports receiving consulting honoraria from AstraZeneca, Boehringer Ingelheim, Genentech, GSK, Novartis, Regeneron, Sanofi and Teva; personal fees from Amgen, Avalo, Cerecor, Cytoreason, Eli Lilly, Equillium, Incyte, Kinaset, Phylaxis, Pulmatrix, Rapt and Sound Biologics. David B. Price has advisory board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Thermofisher; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. The authors report no other conflicts of interest in this work., (© 2022 Chen et al.)
Published: 2022
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9. Patients with Chronic Obstructive Pulmonary Disease and Evidence of Eosinophilic Inflammation Experience Exacerbations Despite Receiving Maximal Inhaled Maintenance Therapy.

Author: Chen S, Miravitlles M, Rhee CK, Pavord ID, Jones R, Carter V, Emmanuel B, Alacqua M, and Price DB
Subjects: Adrenal Cortex Hormones, Disease Progression, Humans, Inflammation chemically induced, Eosinophilia drug therapy, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive drug therapy
Abstract: Background: Some patients with chronic obstructive pulmonary disease (COPD) experience frequent exacerbations despite maximal inhaled therapy ("triple therapy"), possibly leading to high health care resource utilization (HCRU)., Aim: Describe characteristics, future HCRU, and mortality of patients with COPD who experience frequent exacerbations despite triple therapy; characterize individuals who may be candidates for biologic therapies., Methods: This descriptive observational study used primary care data of patients aged ≥40 years in the United Kingdom receiving maintenance therapy for COPD who had ≥1 year of data prior to index date and ≥1 year of follow-up data. We described these patients' clinical and demographic characteristics, including blood eosinophil counts (BEC), pattern of exacerbations, hospitalizations, and corticosteroid exposure, as well as future exacerbations, hospitalizations, and death., Results: Of 43,753 patients with maintenance-treated COPD, 6480 experienced exacerbations despite ≥3 months of triple therapy. Of these, 5669 had available BEC: 1287 (22.7%) had BEC ≥250 cells/µL and ≥3 exacerbations in the year prior to the index date; 471 (36.6%) received ≥4 acute courses of oral corticosteroids. Patients with a pattern of high disease burden continued to have high disease burden: 51.1% experienced ≥3 exacerbations and 2.6% experienced ≥3 hospitalizations. Patients who experienced exacerbations despite triple therapy had a significantly higher risk of COPD-related death than other maintenance-treated patients (5.8% vs 2.1%)., Conclusion: Nearly one-quarter of patients receiving triple therapy for COPD who experienced frequent exacerbations had elevated BEC and ≥3 exacerbations, suggesting a potential mechanism of persistent eosinophilic inflammation that could be a target for eosinophil-depleting biologic therapy., Competing Interests: SC and BE are employees of AstraZeneca. MA was an employee of AstraZeneca at the time of the study. Her current affiliation is CSL Behring, Milan, Italy. DBP has advisory board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Thermofisher, Zentiva (Sanofi Generics); consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service, Zentiva (Sanofi Generics); payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Zentiva (Sanofi Generics); payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; Consultancy agreements - Fees paid to Observational and Pragmatic Research Institute from Airway Vista Secretariat, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L, Talos Health Solutions, WebMD Global LLC; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp, which develops adherence monitoring technology; is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. In the last 5 years, IDP has received speaker’s honoraria for speaking at sponsored meetings from AstraZeneca, Boehringer Ingelheim, Aerocrine, Almirall, Novartis, Teva, Chiesi, Sanofi, Regeneron, Menarini, and GlaxoSmithKline and payments for organizing educational events from AstraZeneca, GlaxoSmithKline, Sanofi/Regeneron, and Teva. He has received honoraria for attending advisory panels with Genentech, Sanofi/Regeneron, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Teva, Merck, Circassia, Chiesi, and Knopp and payments to support Food and Drug Administration approval meetings from GlaxoSmithKline. He has received sponsorship to attend international scientific meetings from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Teva, and Chiesi. He has received a grant from Chiesi to support a Phase 2 clinical trial in Oxford. He is co-patent holder of the rights to the Leicester Cough Questionnaire and has received payments for its use in clinical trials from Merck, Bayer, and Insmed. In 2014-5, he was an expert witness for a patent dispute involving AstraZeneca and Teva. VC is affiliated with the Observational and Pragmatic Research Institute and an employee of Optimum Patient Care Global. CKR received consulting/lecture fees from MSD, AstraZeneca, GlaxoSmithKline, Novartis, Takeda, Mundipharma, Boehringer Ingelheim, Teva, Sanofi, and Bayer. RJ declares grants from AstraZeneca, GlaxoSmithKline, Novartis, and Teva and personal fees for consultancy, speaker’s fees, or travel support from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Nutricia, and the Observational and Pragmatic Research Institute. RJ was an employee of the University of Plymouth at the time of the study. His current affiliation is Plymouth Marjon University, Plymouth, UK. MM has received speaker’s fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Menarini, Rovi, Bial, Sandoz, Takeda, Zambon, CSL Behring, Grifols, and Novartis; consulting fees from AstraZeneca, Atriva Therapeutics, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Bial, Gebro Pharma, Kamada, CSL Behring, Laboratorios Esteve, Ferrer, Inhibrx, Mereo Biopharma, ONO Pharma, Palobiofarma SL, Takeda, Verona Pharma, TEVA, Spin Therapeutics, pH Pharma, Novartis, Sanofi, and Grifols and research grants from Grifols., (© 2022 Chen et al.)
Published: 2022
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10. Characterisation of the Australian Adult Population Living with Asthma: Severe - Exacerbation Frequency, Long-Term OCS Use and Adverse Effects.

Author: Hancock KL, Bosnic-Anticevich S, Blakey JD, Hew M, Chung LP, Cvetkovski B, Claxton S, Del Fante P, Denton E, Doan J, Ranasinghe K, Morgan L, Sharma A, Smith PK, Stewart D, Thompson PJ, Wiseman R, Upham JW, Yan KY, Carter V, Dhillon K, Heraud F, Le T, Vella R, and Price D
Abstract: Introduction: Asthma poses a significant burden for the Australian population. Understanding severe exacerbation rates, and steroid-related burden for adults diagnosed with asthma stands to offer insights into how this could be reduced., Methods: Electronic medical records (EMR) and questionnaires from the Optimum Patient Care Research Database Australia (OPCRDA) were utilised retrospectively. OPCRDA is a real-world database with >800,000 medical records from Australian primary care practices. Outcomes were severe asthma exacerbations in Australian adults, over a 12-month period, stratified by Global Initiative for Asthma (GINA) treatment intensity steps, and steroid associated comorbidities., Results: Of the 7868 adults treated for asthma, 19% experienced at least one severe exacerbation in the last 12-months. Severe exacerbation frequency increased with treatment intensity (≥1 severe exacerbation GINA 1 13%; GINA 4 23%; GINA 5a 33% and GINA 5b 28%). Questionnaire participants reported higher rates of severe exacerbations than suggested from their EMR (32% vs 23%) especially in steps 1, 4 and 5. Patients repeatedly exposed to steroids had an increased risk of osteoporosis (OR 1.95, 95% CI 1.43-2.66) and sleep apnoea (OR 1.78, 95% CI 1.30-2.46)., Conclusion: The Australian population living with GINA 1, 4, 5a and 5b asthma have high severe exacerbation rates and steroid-related burden, especially when compared to other first world countries, with these patients needing alternative strategies or possibly specialist assessment to better manage their condition., Competing Interests: Kerry L. Hancock has received speakers’ fees, consulting honoraria and/or travel grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Menarini Australia, Mylan and Novartis. Sinthia Bosnic-Anticevich has received honorarium for participation in expert advisory boards and given lectures for Teva Pharmaceuticals, AstraZeneca, GSK, Meda, Mundipharma, Sanofi, Mylan and received unrestricted research grants from Mylan, AstraZeneca, Teva and Mundipharma International. John D. Blakey has received speaker fees and/or consulting fees from Chiesi, Sanofi Boehringer Ingelheim and GSK, and his institution has received income from his activity from AstraZeneca and GSK all for unrelated projects. He has received investigator-initiated research funding from Novartis, and research support-in-kind from GSK, Boehringer Ingelheim and Teva. He is a medical advisor for Asthma Australia for which his institution receives income. Li Ping Chung has received speaker and consultancy fees and conference expenses from AstraZeneca, Novartis, GSK, Boehringer Ingelheim and Menarini. Claude Farah has received honoraria from Boehringer Ingelheim, AstraZeneca, GSK, and Sanofi for attending and speaking at educational meetings and advisory boards. Biljana Cvetkovski has received honorarium for participation in expert advisory boards and given presentations for Sanofi and GSK. Mark Hew declares grants and other advisory board fees (made to his institutional employer) from AstraZeneca, GlaxoSmithKline, Novartis, Sanofi, and Seqirus, for unrelated projects. Anita Sharma is a practising Primary Care Physician and Senior Lecturer, School of Clinical Medicine-Primary Care Clinical Unit, University of Queensland. She supervises clinical training of primary care doctors and serves on advisory boards for Diabetes, Heart Failure and Osteoporosis for Novartis, Merck Sharp & Dohme and Boehringer Ingelheim, Eli Lilley and Amgen. Peter K Smith has advisory board membership with Meda, Nestle Nutrition Institute and Sanofi. He has an unrestricted funding for investigator-initiated studies with Meda. He does not have stock options. Philip J Thompson served on advisory boards & provided consultancies for Astra Zeneca, CSL Behring, Boehringer Ingelheim, Grifols, GSK, and Novartis. In the last 12 months, he received honoraria from GSK for presentations. Russell Wiseman has received consulting honoraria and travel grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Menarini Australia, and Novartis. John W. Upham has received speaker fees and consulting fees from Novartis, AstraZeneca, GSK, Sanofi, and Boehringer Ingelheim. Kwok Y Yan has received honoraria for participation in expert advisory boards and presentations for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis and StallergenesGreer. Scott Claxton, Eve Denton, Joe Doan, Peter Del Fante, Lucy Morgan, Kanchanamala Ranasinghe, and Deb Stewart declare no conflict of interest. Victoria Carter is an employee of Optimum Patient Care Global and has 5% shareholding of Optimum Patient Care Australia, who is a part-funder of the ACAER Asthma program initiative and this study. Kiranjeet Dhillon, Florian Heraud, Thao Le and Rebecca Vella are employees of Optimum Patient Care Australia, who is a part-funder of the ACAER Asthma program initiative and this study. David Price has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermofisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L, Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. The authors report no other conflicts of interest in this work., (© 2022 Hancock et al.)
Published: 2022
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11. Variation in Demographic and Clinical Characteristics of Patients with COPD Receiving Care in US Primary Care: Data from the Advancing the Patient EXperience (APEX) in COPD Registry.

Author: Fox C, Pace W, Brandt E, Carter V, Chang KL, Edwards C, Evans A, Gaona G, Han MK, Kaplan A, Kent R, Kocks JWH, Kruszyk M, Chantal LL, LiVoti T, Mahle C, Make B, Ratigan A, Shaikh A, Skolnik N, Stanley B, Yawn BP, and Price DB
Abstract: Introduction: Little is known about the variability in chronic obstructive pulmonary disease (COPD) management and how it may be affected by patient characteristics across different healthcare systems in the US. This study aims to describe demographic and clinical characteristics of people with COPD and compare management across five primary care medical groups in the US., Methods: This is a retrospective observational registry study utilizing electronic health records stored in the Advancing the Patient Experience (APEX) COPD registry. The APEX registry contains data from five US healthcare organizations located in Texas, Ohio, Colorado, New York, and North Carolina. Data on demographic and clinical characteristics of primary care patients with COPD between December 2019 and January 2020 were extracted and compared., Results: A total of 17,192 patients with COPD were included in analysis: Texas (n = 811), Ohio (n = 8722), Colorado (n = 472), New York (n = 1149) and North Carolina (n = 6038). The majority of patients at each location were female (>54%) and overweight/obese (>60%). Inter-location variabilities were noted in terms of age, race/ethnicity, exacerbation frequency, treatment pattern, and prevalence of comorbid conditions. Patients from the Colorado site experienced the lowest number of exacerbations per year while those from the New York site reported the highest number. Hypertension was the most common co-morbidity at 4 of 5 sites with the highest prevalence in New York. Depression was the most common co-morbidity in Ohio. Treatment patterns also varied by site; Colorado had the highest proportion of patients not on any treatment. ICS/LABA was the most commonly prescribed treatment except in Ohio, where ICS/LABA/LAMA was most common., Conclusions and Relevance: Our data show heterogeneity in demographic, clinical, and treatment characteristics of patients diagnosed with COPD who are managed in primary care across different healthcare organizations in the US., Competing Interests: Chester Fox declares no conflict of interest. Wilson Pace is on the advisory board for Mylan; stock from Eli Lilly, Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi. Elias Brandt, Gabriela Gaona, and Rachel Kent are employees of the DARTNet Institute. Amanda Ratigan is a consultant to Boehringer-Ingelheim, but at the time of this disclosure had received no funding directly or through any organization she works for from Boehringer-Ingelheim. Victoria Carter, Alexander Evans, Maja Kruszyk, Chantal Le Lievre, and Brooklyn Stanley are employees of Optimum Patient Care, a co-founder of the APEX COPD initiative. Chelsea Edwards was an employee of Optimum Patient Care Australia at the time that this study was conducted. Ku-Lang Chang declares no conflict of interest. MeiLan K Han reports personal fees from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Cipla, Chiesi, Novartis, Pulmonx, Teva, Verona, Merck, Mylan, Sanofi, DevPro, Aerogen, Polarian, Regeneron, United Therapeutics, UpToDate, Altesa Biopharma, Medscape and Integrity. She has received either in kind research support or funds paid to the institution from the NIH, Novartis, Sunovion, Nuvaira, Sanofi, AstraZeneca, Boehringer Ingelheim, Gala Therapeutics, Biodesix, the COPD Foundation and the American Lung Association. She has participated in Data Safety Monitoring Boards for Novartis and Medtronic with funds paid to the institution. She has received stock options from Meissa Vaccines and Altesa Biopharma. Alan Kaplan is a member of the advisory board of, or speakers bureau for, AstraZeneca, Behring, Boehringer Ingelheim, Covis, Cipla, Grifols, GlaxoSmithKline, Merck Frosst, Novo Nordisk, Novartis, Pfizer, Purdue, Sanofi, Teva, and Trudel. Janwillem Kocks reports grants, personal fees and non-financial support from AstraZeneca, grants, personal fees and non-financial support from Boehringer Ingelheim, grants and personal fees from Chiesi Pharmaceuticals, grants, personal fees and non-financial support from GSK, grants and non-financial support from Mundi Pharma, grants and personal fees from TEVA, grants and personal fees from Novartis, personal fees from MSD, personal fees from COVIS Pharma, grants from Valneva outside the submitted work; and Janwillem Kocks holds <5% shares of Lothar Medtec GmbH and 72.5% of shares in the General Practitioners Research Institute. Tessa Li Voti was an employee of Optimum Patient Care at the time this study was conducted. Cathy Mahle and Asif Shaikh are employees of Boehringer Ingelheim, a co-founder of the APEX COPD initiative. Barry Make reports funding from the NHLBI for the COPDGene study; grants and medical advisory boards from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, and Sunovion; personal fees for DSMB from Spiration and Shire/Baxalta; CME personal fees from WebMD, National Jewish Health, American College of Chest Physicians, Projects in Knowledge, Hybrid Communications, SPIRE Learning, Ultimate Medical Academy, Catamount Medical, Eastern Pulmonary Society, Catamount Medical Communications Medscape, Eastern VA Medical Center, Academy Continued Healthcare Learning, and Mt. Sinai Medical Center; royalites from Up-To-Date; medical advisory boards from Novartis, Phillips, Third Pole, Science 24/7, and Verona; grants from Pearl; outside the submitted work. Neil Skolnik is on advisory boards for AstraZeneca, Teva, Lilly, Boehringer Ingelheim, Sanofi, Janssen Pharmaceuticals, Intarcia, Mylan, and GlaxoSmithKline; Payment for lectures/speaking engagements from AstraZeneca and Boehringer Ingelheim; Research Support from Sanofi, AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline. Barbara P Yawn has served on COPD-related advisory boards for GlaxoSmithKline, AstraZeneca, Novartis, and Boehringer Ingelheim, Teva, receives consultancy fees from ndd Medical Technology and received COPD-related investigator-initiated research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. David Price has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermo Fisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance, British Lung Foundation, and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermo Fisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline., (© 2022 Fox et al.)
Published: 2022
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12. Interclass Difference in Pneumonia Risk in COPD Patients Initiating Fixed Dose Inhaled Treatment Containing Extrafine Particle Beclometasone versus Fine Particle Fluticasone.

Author: Price DB, Henley W, Cançado JED, Fabbri LM, Kerstjens HAM, Papi A, Roche N, Şen E, Singh D, Vogelmeier CF, Barille S, Nudo E, Carter V, Skinner D, Vella R, and Georges G
Subjects: Administration, Inhalation, Adult, Beclomethasone, Cohort Studies, Fluticasone, Formoterol Fumarate, Humans, Treatment Outcome, Pneumonia chemically induced, Pneumonia diagnosis, Pneumonia drug therapy, Pulmonary Disease, Chronic Obstructive chemically induced, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive drug therapy
Abstract: Background: Inhaled corticosteroids (ICS) afford therapeutic benefits in some COPD patients, but their widespread use is cautioned due to an increased risk of developing pneumonia. Subclass variations exist, and the risk profile differs for individual ICS. Formulation particle size has been identified as a potential effect modifier. The present study compared the risk of pneumonia among new COPD users of fixed-dose combination inhalers containing fine-particle fluticasone (fp-FDC-F) versus extrafine particle beclometasone (ef-FDC-BDP)., Methods: A propensity matched historical cohort study was conducted using data from the Optimum Patient Care Research Database. COPD patients aged ≥40 years with ≥1 year of continuous medical data who initiated fp-FDC-F or ef-FDC-BDP were compared. The primary outcome was time to pneumonia event, as treated, using either sensitive (physician diagnosed) or specific (physician diagnosed and x-ray or hospital admission confirmed) definitions., Results: A total of 13,316 patients were matched. Initiation of fp-FDC-F (mean dosage furoate 99 µg; propionate 710 µg) was associated with an increased risk of pneumonia versus ef-FDC-BDP (mean beclometasone dose 395 µg), irrespective of definition (sensitive HR 1.38 95% CI 1.14-1.68; specific HR 1.31 95% CI 1.05-1.62)., Conclusion: In the current investigation, we found that in comparison to extrafine beclomethasone, commencing a formulation containing fluticasone is associated with an increased risk of developing pneumonia. These observations support the idea that not all ICS are equal in their adverse effects and subclass variations exist and should be carefully considered in the treatment choice., Competing Interests: David B Price has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermofisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. Derek Skinner, Rebecca Vella and Victoria Carter are affiliated with the Observational and Pragmatic Research Institute. William Henley is affiliated with the Observational and Pragmatic Research Institute and reports travel support from Eisai Limited. Leonardo M. Fabbri reports lecture fees and/or consultancies from Alfasigma, AstraZeneca, Chiesi, Boehringer Ingelheim, GlaxoSmithKline, Lusofarmaco, Merck, Novartis, Zambon, and Verona Pharma. Huib AM Kerstjens reports grants and consultancy/advisory board participation from/for AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, and Novartis, all outside the submitted work. All were paid to his institution. Alberto Papi is on the boards for and has received research and travel support and consultancy and lecture fees from Chiesi Farmaceutici, AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Merck Sharp & Dohme, Takeda, Mundipharma Research Limited, and Teva; has received lecture fees and travel support from Menarini, Novartis, and Zambon; is on the boards for and has received lecture fees and travel support from Pfizer and has received research support from Sanofi. Nicolas Roche reports grants and personal fees from Boehringer Ingelheim, Novartis, GSK, and Pfizer, and personal fees from Teva, GSK, AstraZeneca, Chiesi, Sanofi, and Zambon. Dave Singh has received personal fees from GSK, Cipla, Genentech and Peptinnovate, and personal fees and grant support from AstraZeneca, Boehringer Ingelheim, Chiesi, Glenmark, Gossamerbio, Menarini, Mundipharma, Novartis, Pfizer, Pulmatrix, Theravance and Verona.. Claus F Vogelmeier gave presentations at symposia and/or served on scientific advisory boards sponsored by Aerogen, AstraZeneca, Boehringer Ingelheim, CSL Behring, Chiesi, GlaxoSmithKline, Grifols, Menarini, Novartis, Nuvaira, and MedUpdate. Elif Şen report no conflict of interest. José Eduardo Delfini Cançado reports grants and personal fees from Aché, AstraZeneca, Boehringer Ingelheim, Chiesi, Eurofarma, GSK, Glenmarkpharma, Novartis, Sanofi and Zambon. Elena Nudo, Sara Barile and George Georges are employees of Chiesi Farmaceutici, S.p.A. George Georges reports stock ownerships from GSK, Sanofi, Insmed, Regeneron, Gilead, Vertex, Ultragenyx, and Fibrogen. The authors report no other conflicts of interest in this work., (© 2022 Price et al.)
Published: 2022
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13. Real World Biologic Use and Switch Patterns in Severe Asthma: Data from the International Severe Asthma Registry and the US CHRONICLE Study.

Author: Menzies-Gow AN, McBrien C, Unni B, Porsbjerg CM, Al-Ahmad M, Ambrose CS, Dahl Assing K, von Bülow A, Busby J, Cosio BG, FitzGerald JM, Garcia Gil E, Hansen S, aHeaney LG, Hew M, Jackson DJ, Kallieri M, Loukides S, Lugogo NL, Papaioannou AI, Larenas-Linnemann D, Moore WC, Perez-de-Llano LA, Rasmussen LM, Schmid JM, Siddiqui S, Alacqua M, Tran TN, Suppli Ulrik C, Upham JW, Wang E, Bulathsinhala L, Carter VA, Chaudhry I, Eleangovan N, Murray RB, Price CA, and Price DB
Abstract: Introduction: International registries provide opportunities to describe use of biologics for treating severe asthma in current clinical practice. Our aims were to describe real-life global patterns of biologic use (continuation, switches, and discontinuations) for severe asthma, elucidate reasons underlying these patterns, and examine associated patient-level factors., Methods: This was a historical cohort study including adults with severe asthma enrolled into the International Severe Asthma Registry (ISAR; http://isaregistries.org, 2015-2020) or the CHRONICLE Study (2018-2020) and treated with a biologic. Eleven countries were included (Bulgaria, Canada, Denmark, Greece, Italy, Japan, Kuwait, South Korea, Spain, UK, and USA). Biologic utilization patterns were defined: 1) continuing initial biologic; 2) stopping biologic treatment; or 3) switching to another biologic. Reasons for discontinuation/switching were recorded and comparisons drawn between groups., Results: A total of 3531 patients were included. Omalizumab was the most common initial biologic in 2015 (88.2%) and benralizumab in 2019 (29.6%). Most patients (79%; 2791/3531) continued their first biologic; 10.2% (356/3531) stopped; 10.8% (384/3531) switched. The most frequent first switch was from omalizumab to an anti-IL-5/5R (49.6%; 187/377). The most common subsequent switch was from one anti-IL-5/5R to another (44.4%; 20/45). Insufficient efficacy and/or adverse effects were the most frequent reasons for stopping/switching. Patients who stopped/switched were more likely to have a higher baseline blood eosinophil count and exacerbation rate, lower lung function, and greater health care resource utilization., Conclusion: The description of real-life patterns of continuing, stopping, or switching biologics enhances our understanding of global biologic use. Prospective studies involving structured switching criteria could ascertain optimal strategies to identify patients who may benefit from switching., Competing Interests: Andrew N. Menzies-Gow has attended advisory boards for AstraZeneca, GlaxoSmithKline, Novartis, Roche, Sanofi and Teva, and has received speaker fees from AstraZeneca, Novartis, Teva, and Sanofi. He has participated in research with AstraZeneca for which his institution has been remunerated and has attended international conferences with Teva. He has had consultancy agreements with AstraZeneca and Sanofi. Claire McBrien has attended an international conference with Boehringer Ingelheim and a national meeting with TEVA. Celeste M. Porsbjerg has attended advisory boards for AstraZeneca, Novartis, TEVA, and Sanofi-Genzyme; has given lectures at meetings supported by AstraZeneca, Novartis, TEVA, Sanofi-Genzyme, and GlaxoSmithKline; has taken part in clinical trials sponsored by AstraZeneca, Novartis, MSD, Sanofi-Genzyme, GlaxoSmithKline, and Novartis; and has received educational and research grants from Astra Zeneca, Novartis, TEVA, GlaxoSmithKline, ALK, and Sanofi-Genzyme. Mona Al-Ahmad has received advisory board and speaker fees from AstraZeneca, Sanofi, Novartis, and GlaxoSmithKline. Anna von Bülow reports speakers fees and consultancy fees from AstraZeneca and Novartis, outside the submitted work. She has also attended advisory board for Novartis. Borja G. Cosio declares grants from Chiesi and GSK; personal fees for advisory board activities from Chiesi, GSK, Novartis, Sanofi, Teva, and AstraZeneca; and payment for lectures/speaking engagements from Chiesi, Novartis, GSK, Menarini, and AstraZeneca, outside the submitted work. Liam G. Heaney declares he has received grant funding, participated in advisory boards and given lectures at meetings supported by Amgen, AstraZeneca, Boehringer Ingelheim, Circassia, Hoffmann la Roche, GlaxoSmithKline, Novartis, Theravance, Evelo Biosciences, Sanofi, and Teva; he has received grants from MedImmune, Novartis UK, Roche/Genentech Inc, and Glaxo Smith Kline, Amgen, Genentech/Hoffman la Roche, Astra Zeneca, MedImmune, Glaxo Smith Kline, Aerocrine and Vitalograph; he has received sponsorship for attending international scientific meetings from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK and Napp Pharmaceuticals; he has also taken part in asthma clinical trials sponsored by Boehringer Ingelheim, Hoffmann la Roche, and GlaxoSmithKline for which his institution received remuneration; he is the Academic Lead for the Medical Research Council Stratified Medicine UK Consortium in Severe Asthma which involves industrial partnerships with a number of pharmaceutical companies including Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Hoffmann la Roche, and Janssen. Mark Hew declares grants and other advisory board fees (made to his institutional employer) from AstraZeneca, GlaxoSmithKline, Novartis, Sanofi, Teva, and Seqirus, for unrelated projects. David J Jackson has received advisory board and speaker fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Teva, Napp, Chiesi, Novartis, Sanofi and research grant funding from AstraZeneca. Stelios Loukides received honorarium form Novartis, Astra, GSK; received grants from GSK. Njira Lugogo received consulting fees for advisory board participation from Amgen, AstraZeneca, Genentech, GSK, Novartis, Regeneron, Sanofi, and Teva; honoraria for non-speakers bureau presentations from GSK and Astra Zeneca; and travel support from Astra Zeneca and GSK; her institution received research support from Amgen, AstraZeneca, Avillion, Evidera, Gossamer Bio, Genentech, GSK, Janssen, Regeneron, Sanofi, Novartis and Teva. She is an honorary faculty member of Observational and Pragmatic Research Institute (OPRI) but does not receive compensation for this role. Andriana I Papaioannou has received fees and honoraria from Menarini, GSK, Novartis, Elpen, Boehringer Ingelheim, AstraZeneca, and Chiesi. Désirée Larenas Linnemann reports personal fees from Allakos, Amstrong, Astrazeneca, Chiesi, DBV Technologies, Grunenthal, GSK, Mylan/Viatris, Menarini, MSD, Novartis, Pfizer, Sanofi, Siegfried, UCB, Gossamer, Carnot and grants from Sanofi, Astrazeneca, Novartis, Circassia, GSK, Purina institute, Abvvie, Lilly, Pfizer, outside the submitted work. Wendy C. Moore is on advisory boards for and reports grant and personal fees from AstraZeneca, Sanofi Regeneron, Genentech, Gossamer Bio Inc, Cumberland NHLBI/NHLBI, and GlaxoSmithKline. She is also a member of the writing and steering committee for the CHRONICLE study as well as a PI of the clinical trial at Wake Forest.). Luis Perez-de-Llano declares non-financial support, personal fees, and grants from Teva; non-financial support and personal fees from Boehringer Ingelheim, Esteve, FAES, GlaxoSmithKline, Mundipharma, and Novartis; personal fees and grants from AstraZeneca and Chiesi; personal fees from Sanofi, MSD, Techdow Pharma Leo-Pharma, GEBRO, and GILEAD; and non-financial support from Menarini outside the submitted work. Linda M. Rasmussen declares speakers fees from AstraZeneca, Boehringer Ingelheim, TEVA, ALK, GlaxoSmithKline, and Mundipharma, outside the submitted work and attended advisory board for AstraZeneca, Sanofi and Teva. Salman Siddiqui declares personal fees from AstraZeneca, GlaxoSmithKline, Novartis, Chiesi, Knopp Biosciences, CSL Behring, Mundipharma, ERT Medical, Owlstone Medical, Boehringer Ingelheim, outside the submitted work. Christopher S. Ambrose and Trung N. Tran are employees of AstraZeneca, sponsor and funder of the CHRONICLE study and a co-funder of the International Severe Asthma Registry. Esther Garcia Gil and Marianna Alacqua were employees of AstraZeneca at the time this study was completed. Charlotte Suppli Ulrik has attended advisory boards for AstraZeneca, ALK-Abello, GSK, Boehringer-Ingelheim, Novartis, Chiesi, TEVA, and Sanofi-Genzyme; has given lectures at meetings supported by AstraZeneca, Sandoz, Mundipharma, Chiesi, Boehringer-Ingelheim, Orion Pharma, Novartis, TEVA, Sanofi-Genzyme, and GlaxoSmithKline; has taken part in clinical trials sponsored by AstraZeneca, Novartis, Merck, InsMed, ALK-Abello, Sanofi-Genzyme, GlaxoSmithKline, Boehringer-Ingelheim, Regeneron, Chiesi and Novartis; and has received educational and research grants from AstraZeneca, MundiPharma, Boehringer-Ingelheim, Novartis, TEVA, GlaxoSmithKline and Sanofi-Genzyme. John W. Upham has received speaker fees and consulting fees from Novartis, AstraZeneca, GSK, Sanofi, and Boehringer Ingelheim. Eileen Wang has received honoraria from AstraZeneca, GlaxoSmithKline, Clinical Care Options, and Wefight. She has been an investigator on clinical trials sponsored by AstraZeneca, Optimum Patient Care, Sanofi, Sema4, GlaxoSmithKline, Genentech, Novartis, Teva, and National Institute of Allergy and Infectious Diseases (NIAID) for which her institution has received funding. Karin Dahl Assing, Susanne Hansen, Maria Kallieri, Johannes Schmid, John Busby, J. Mark FitzGerald, and Ruth B. Murray declare no relevant conflicts of interest concerning this paper. Victoria A. Carter and Chris A. Price are employees of Optimum Patient Care Global, a co-funder of the International Severe Asthma Registry. Neva Eleangovan is an employee of the Observational and Pragmatic Research Institute (OPRI), which conducted this study in collaboration with Optimum Patient Care and AstraZeneca. OPRI has also conducted paid research in respiratory disease on behalf of the following other organisations in the past 3 years: Aerocrine, AKL Research and Development Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mapi Group, Meda, Mylan, Mundipharma, Napp, Novartis, Orion, Regeneron, Roche, Takeda, Teva, and Zentiva (a Sanofi company). Lakmini Bulathsinhala, Isha Chaudhry, and Bindhu Unni were employees of the Observational and Pragmatic Research Institute, which conducted this study in collaboration with Optimum Patient Care and AstraZeneca. David Price has advisory board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Thermofisher; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. The authors report no other conflicts of interest in this work., (© 2022 Menzies-Gow et al.)
Published: 2022
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14. Association Between a Type 2 Inflammatory Disease Burden Score and Outcomes Among Patients with Asthma.

Author: Price D, Menzies-Gow A, Bachert C, Canonica GW, Kocks J, Khan AH, Ye F, Rowe PJ, Lu Y, Kamat S, Carter V, and Voorham J
Abstract: Background: Although prevalence of co-existing type 2 inflammatory diseases (cT2) in asthma patients has been reported, limited data exist regarding their impact on asthma outcomes., Objective: To assess the impact of cT2 burden on asthma outcomes and to evaluate patterns of clustering of cT2 in a real-world setting., Methods: From medical records of 4.5 million enrollees in 650 primary care practices in the UK (January 2010-December 2017), patients with ≥1 diagnosis code for asthma at any time pre-index date (date of most recent asthma-related medical encounter) and ≥2 asthma-related prescriptions during the year before index date were categorized into the Global Initiative of Asthma (GINA) guideline severity steps. A cT2 burden score (range 0-9) was assigned based on the total number of co-existing conditions (allergic conjunctivitis, allergic rhinitis, anaphylaxis, eczema/atopic dermatitis, chronic rhinosinusitis, eosinophilic esophagitis, food allergy, nasal polyps, or urticaria) for which patients received a medical diagnosis. Multivariate regression models evaluated associations between cT2 burden score and asthma exacerbations and asthma control. Factor analysis was performed to assess which cT2 comorbidities were correlated and exhibited patterns of clustering., Results: Overall, 245,893 patients with asthma were included (mean [SD] age 44.8 [22.1] years; 43.8% male). Between 55% (GINA step 1) and 60% (GINA step 5) of asthma patients had a medical diagnosis for ≥1 other type2dx. Patients with increased cT2 burden were significantly more likely to experience asthma exacerbations and less likely to achieve asthma control., Conclusion: Asthma patients with a higher cumulative cT2 burden score were more likely to experience worse asthma outcomes than those without any cT2 (burden score of 0)., Competing Interests: David Price: Board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermofisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. Andrew Menzies-Gow: attended advisory boards for AstraZeneca, Sanofi, Teva, Novartis, Boehringer Ingelheim, and GlaxoSmithKline. He has received lecture fees from Novartis, Teva, Vectura, Boehringer Ingelheim, and AstraZeneca. He has attended international conferences with Teva. He has consultancy agreements with Sanofi, AstraZeneca, and Vectura. Claus Bachert: supported by grants from the European Commission’s Seventh Framework programme under grant agreement no. 260895 (PREDICTA); from the Flemish Scientific Research Board, FWO, No. A12/5-HB- KH3, by the Global Allergy and Asthma European Network (GA2LEN) project G.0436.04, 3G.0489, G.0642.10N; and by the Interuniversity Attraction Poles Program–Belgian State Belgian Science Policy, No. IAP P7/30. He also served as speaker for Sanofi, Novartis, GlaxoSmithKline, AstraZeneca and Mylan. Giorgio Walter Canonica: received grants and unrestricted funding for investigator-initiated studies and independent research from AstraZeneca, Chiesi, GSK, ALK, Allergy Therapeutics, Novartis, Sanofi Regeneron, Stallergenes Greer; fees for advisory boards or lecturing from AstraZeneca, Chiesi, GlaxoSmithKline, ALK, Allergy Therapeutics, Novartis, Sanofi Regeneron, Stallergenes Greer, HAL Allergy, Mundipharma Menarini, Malesci Guidotti, and Valeas. Janwillem W. H. Kocks: reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Novartis, personal fees from MSD and COVIS, grants from Chiesi, Mundipharma, and Teva outside the submitted work, and is a shareholder of the General Practitioners Research Institute. Asif H. Khan and Paul Rowe: employees of and stockholders in Sanofi. Siddhesh Kamat: employee of and stockholder in Regeneron Pharmaceuticals, Inc. At the time of development of this manuscript, Fen Ye was an employee of and stockholder in Sanofi and Yufang Lu was an employee of and stockholder in Regeneron Pharmaceuticals. Victoria Carter and Jaco Voorham (at the time of the study): employees of Observational and Pragmatic Research Institute Pte Ltd, which has conducted paid research in respiratory disease on behalf of the following organizations in the past 5 years: Aerocrine, AKL Research and Development Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Orion, Takeda, Teva, and Zentiva (a Sanofi company). The authors report no other conflicts of interest in this work., (© 2021 Price et al.)
Published: 2021
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15. CONQUEST Quality Standards: For the Collaboration on Quality Improvement Initiative for Achieving Excellence in Standards of COPD Care.

Author: Pullen R, Miravitlles M, Sharma A, Singh D, Martinez F, Hurst JR, Alves L, Dransfield M, Chen R, Muro S, Winders T, Blango C, Muellerova H, Trudo F, Dorinsky P, Alacqua M, Morris T, Carter V, Couper A, Jones R, Kostikas K, Murray R, and Price DB
Subjects: Humans, Primary Health Care, Quality of Life, Secondary Care, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive therapy, Quality Improvement
Abstract: Background: Chronic obstructive pulmonary disease (COPD) are managed predominantly in primary care. However, key opportunities to optimize treatment are often not realized due to unrecognized disease and delayed implementation of appropriate interventions for both diagnosed and undiagnosed individuals. The COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care (CONQUEST) is the first-of-its-kind, collaborative, interventional COPD registry. It comprises an integrated quality improvement program focusing on patients (diagnosed and undiagnosed) at a modifiable and higher risk of COPD exacerbations. The first step in CONQUEST was the development of quality standards (QS). The QS will be imbedded in routine primary and secondary care, and are designed to drive patient-centered, targeted, risk-based assessment and management optimization. Our aim is to provide an overview of the CONQUEST QS, including how they were developed, as well as the rationale for, and evidence to support, their inclusion in healthcare systems., Methods: The QS were developed (between November 2019 and December 2020) by the CONQUEST Global Steering Committee, including 11 internationally recognized experts with a specialty and research focus in COPD. The process included an extensive literature review, generation of QS draft wording, three iterative rounds of review, and consensus., Results: Four QS were developed: 1) identification of COPD target population, 2) assessment of disease and quantification of future risk, 3) non-pharmacological and pharmacological intervention, and 4) appropriate follow-up. Each QS is followed by a rationale statement and a summary of current guidelines and research evidence relating to the standard and its components., Conclusion: The CONQUEST QS represent an important step in our aim to improve care for patients with COPD in primary and secondary care. They will help to transform the patient journey, by encouraging early intervention to identify, assess, optimally manage and followup COPD patients with modifiable high risk of future exacerbations., Competing Interests: Rachel Pullen and Amy Couper are employees of the Observational and Pragmatic Research Institute, which is a research collaborator of the CONQUEST initiative with Optimum Patient Care and AstraZeneca. Marc Miravitlles reports speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Menarini, Rovi, Bial, Sandoz, Zambon, CSL Behring, Grifols and Novartis, consulting fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Bial, Gebro Pharma, Kamada, CSL Behring, Laboratorios Esteve, Ferrer, Mereo Biopharma, Verona Pharma, TEVA, Spin Therapeutics, pH Pharma, Novartis, Sanofi and Grifols and research grants from GlaxoSmithKline and Grifols. Anita Sharma is a practising Primary Care Physician and Senior Lecturer, School of Clinical Medicine-Primary Care Clinical Unit, University of Queensland. She supervises clinical training of primary care doctors and serves on advisory boards for Diabetes, Heart Failure and Osteoporosis for Novartis, Merck Sharp & Dohme and Boehringer Ingelheim, Eli Lilley and Amgen. Dave Singh has received personal fees from Aerogen, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, CSL Behring, Epiendo, Glenmark, Gossamerbio, Kinaset, Menarini, Novartis, PulmatrixSanofi, Theravance and Verona. Fernando Martinez has received personal fees and non-financial support from the American College of Chest Physicians, AstraZeneca, Boehringer Ingelheim, ConCert, Genentech, GSK, Inova Fairfax Health System, Miller Communications, National Society for Continuing Education, Novartis, Pearl Pharmaceuticals, PeerView Communications, Prime Communications, Puerto Rico Respiratory Society, Chiesi, Sunovion, Theravance, Potomac, University of Alabama Birmingham, Physicians Education Resource, Canadian Respiratory Network, Teva and Dartmouth; non-financial support from ProterrixBio, Gilead, Nitto and Zambon; and personal fees from Columbia University, Integritas, MD magazine, Methodist Hospital Brooklyn, New York University, UpToDate, WebMD/MedScape, Western Connecticut Health Network, Patara/Respivant, PlatformIQ, American Thoracic Society, Rockpointe, Rare Disease Healthcare Communications and France Foundation; grant support from NIH; and is a member of steering committees for Afferent/Merck, Biogen, Veracyte, Prometic, Bayer, Bridge Biotherapeutics and ProMedior. John Hurst has received personal payment and payment to his institution (UCL), including research grants, reimbursement for advisory work and educational activities, and support to attend meetings from pharmaceutical companies that make medicines to treat COPD, which includes AstraZeneca, Boehringer Ingelheim, Chiesi and Novartis. ; Luís Alves has served as an advisor or consultant for AstraZeneca, GlaxoSmithKline; served as a speaker or a member of a speakers bureau for Astra-Zeneca, BIAL, GlaxoSmithKline, and Novartis Pharmaceuticals Corporation. Luis Alves also reports personal fees from Optimum Patient Care Global Limited, during the conduct of the study. He is also a member of the Education Subcommittee of the International Primary Care Respiratory Group and a member of the of GRESP, the Portuguese Primary Care Study Group for Respiratory Diseases. Mark Dransfield has received grant support from the Department of Defense and NIH; personal fees from AstraZeneca, Boehringer Ingelheim, PneumRx/BTG, Genentech, BostonScientific, Quark Pharmaceuticals, Teva, and GSK; and contracted clinical trial support from Boehringer Ingelheim, Novartis, AstraZeneca, Yungjin, PneumRx/BTG, Pulmonx, Boston Scientific and GSK. Rongchang Chen has received grant support from AstraZeneca, Boehringer Ingelheim, and GSK; and reimbursement for advisory work and educational activities from AstraZeneca, Boehringer Ingelheim, GSK, Novartis. Shigeo Muro reported lecture and advisory fees from Novartis Pharma and AstraZeneca; lecture fees and grants from Boehringer Ingelheim and Fukuda Life Tech; advisory fees from GlaxoSmithKline; grants from Eisai Pharmaceutical, Otsuka Pharmaceutical and Fuji Film Medical; and lecture fees from Astellas Pharmaceutical, Kyorin Pharmaceutical and Meiji Seika Pharma. Tonya Winders has received personal fees from AstraZeneca, GSK, Novartis, Genentech, and Sanofi/Regeneron alliance. Allergy & Asthma Network & Global Allergy & Airways Patient Platform has received funds for unbranded disease awareness and education from AZ, BI, GSK, Novartis, Genentech, Viatris and Sanofi/Regeneron. Christopher Blango was an employee of AstraZeneca and hold stock and/or stock options in the company. Currently employed at the Janssen Pharmaceutical Companies of J&J. Hana Müllerová, Tamsin Morris, Frank Trudo and Paul Dorinsky are employees of AstraZeneca and hold stock and/or stock options in the company. AstraZeneca is a co-funder of the CONQUEST initiative. Marianna Alacqua was an employee of AstraZeneca at the time of manuscript development. Currently employed at CSL Behring SpA. Victoria Carter is an employee of Optimum Patient Care, a co-funder of the CONQUEST initiative. Rupert Jones declares grants from Astra Zeneca, Glaxo Smith Kline, Novartis and Teva and personal fees for consultancy, speakers fees or travel support from Astra Zeneca, Boehringer Ingelheim, Glaxo Smith Kline, Novartis and OPRI. Konstantinos Kostikas was an employee and shareholder of Novartis Pharma AG until 31.10.2018. He has received honoraria for presentations and consultancy fees from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Menarini, Novartis and Sanofi. His department has received funding and grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Innovis, ELPEN, GSK, Menarini, Novartis and NuvoAir. He is a member of the GOLD Assembly. Ruth Murray reports personal fees from OPC, during the conduct of the study. David B Price has board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermofisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. The authors report no other conflicts of interest in this work., (© 2021 Pullen et al.)
Published: 2021
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16. Risk Predictors and Symptom Features of Long COVID Within a Broad Primary Care Patient Population Including Both Tested and Untested Patients.

Author: Jones R, Davis A, Stanley B, Julious S, Ryan D, Jackson DJ, Halpin DMG, Hickman K, Pinnock H, Quint JK, Khunti K, Heaney LG, Oliver P, Siddiqui S, Pavord I, Jones DHM, Hyland M, Ritchie L, Young P, Megaw T, Davis S, Walker S, Holgate S, Beecroft S, Kemppinen A, Appiagyei F, Roberts EJ, Preston M, Hardjojo A, Carter V, van Melle M, and Price D
Abstract: Introduction: Symptoms may persist after the initial phases of COVID-19 infection, a phenomenon termed long COVID. Current knowledge on long COVID has been mostly derived from test-confirmed and hospitalized COVID-19 patients. Data are required on the burden and predictors of long COVID in a broader patient group, which includes both tested and untested COVID-19 patients in primary care., Methods: This is an observational study using data from Platform C19, a quality improvement program-derived research database linking primary care electronic health record data (EHR) with patient-reported questionnaire information. Participating general practices invited consenting patients aged 18-85 to complete an online questionnaire since 7th August 2020. COVID-19 self-diagnosis, clinician-diagnosis, testing, and the presence and duration of symptoms were assessed via the questionnaire. Patients were considered present with long COVID if they reported symptoms lasting ≥4 weeks. EHR and questionnaire data up till 22nd January 2021 were extracted for analysis. Multivariable regression analyses were conducted comparing demographics, clinical characteristics, and presence of symptoms between patients with long COVID and patients with shorter symptom duration., Results: Long COVID was present in 310/3151 (9.8%) patients with self-diagnosed, clinician-diagnosed, or test-confirmed COVID-19. Only 106/310 (34.2%) long COVID patients had test-confirmed COVID-19. Risk predictors of long COVID were age ≥40 years (adjusted Odds Ratio [AdjOR]=1.49 [1.05-2.17]), female sex (adjOR=1.37 [1.02-1.85]), frailty (adjOR=2.39 [1.29-4.27]), visit to A&E (adjOR=4.28 [2.31-7.78]), and hospital admission for COVID-19 symptoms (adjOR=3.22 [1.77-5.79]). Aches and pain (adjOR=1.70 [1.21-2.39]), appetite loss (adjOR=3.15 [1.78-5.92]), confusion and disorientation (adjOR=2.17 [1.57-2.99]), diarrhea (adjOR=1.4 [1.03-1.89]), and persistent dry cough (adjOR=2.77 [1.94-3.98]) were symptom features statistically more common in long COVID., Conclusion: This study reports the factors and symptom features predicting long COVID in a broad primary care population, including both test-confirmed and the previously missed group of COVID-19 patients., Competing Interests: Rupert Jones reports grants, personal fees, and non-financial support from AstraZeneca and OPRI, personal fees and non-financial support from Boehringer Ingelheim, grants, personal fees, and non-financial support from GSK, grants and non-financial support from Novartis, non-financial support from Nutricia, and personal fees from Pfizer outside the submitted work. Andrew Davis was an employee of Observational and Pragmatic Research Institute at the time this study was conducted. Brooklyn Stanley and Anu Kemppinen are employees of Observational and Pragmatic Research Institute, which conducted this study and conducted paid research in respiratory disease on behalf of the following other organizations in the past 5 years: Aerocrine, AKL Research and Development Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp, Novartis, Orion, Takeda, Teva, Zentiva (a Sanofi company). Dermot Ryan has (in the last 3 years) lectured on behalf of, received sponsorship from, or acted as a paid advisor to Mylan, AZ, Chiesi, Novartis, GSK, Boehringer Ingelheim and Regeneron. David J Jackson has received advisory board and speaker fees from AstraZeneca, GSK, BI, Teva, Napp, Chiesi, Novartis and research grant funding from AstraZeneca. David MG Halpin has received sponsorship to attend international meetings, and honoraria for lecturing, attending advisory boards and preparing educational materials from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis and Pfizer. Jennifer K Quint reports grants from MRC, grants from The Health Foundation, grants and personal fees from AZ, grants from Bayer, grants and personal fees from Chiesi, grants and personal fees from GSK, grants and personal fees from BI, outside the submitted work. Kamlesh Khunti has been a consultant and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, and Merck Sharp & Dohme; has received grants in support of investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Pfizer, and Boehringer Ingelheim; has served on advisory boards for Novo Nordisk, SanofiAventis, Lilly, and Merck Sharp & Dohme; and is supported by the UK National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands and the NIHR Leicester Biomedical Research Centre. Liam G Heaney is an Academic Lead for the UK MRC Consortium for Stratified Medicine in Severe Asthma – Industrial Pharma partners Amgen, AstraZeneca, MedImmune, Janssen, Novartis, Roche/Genentech, GlaxoSmithKline, and Boehringer Ingelheim; prior project grant funding from MedImmune, Novartis UK, Roche/Genentech, and GlaxoSmithKline; has taken part in Advisory Boards/Lectures supported by Novartis, Roche/Evelo Biosciences, Genentech, GlaxoSmithKline, Teva, Theravance and Vectura; has travel funding support to international respiratory meetings (AstraZeneca, Chiesi, Novartis, Boehringer Ingelheim, Teva, and GlaxoSmithKline) and has taken part in asthma clinical trials (GlaxoSmithKline, Schering Plough, Synairgen, Novartis, and Roche/Genentech) for which his institution was remunerated. Salman Siddiqui reports advisory board/advisory services and speaker fees from AstraZeneca, GlaxoSmithKline, Chiesi, Boehringer Ingelheim, Novartis, Mundipharma, ERT medical, Owlstone Medical and received grants from UKRI PHOSP-COVID consortium. Ian Pavord reports grants from NIHR and personal fees from Aerocrine, Almirall, Boehringer Ingelheim, Chiesi, Circassia, Genentech, GlaxoSmithKline, Knopp, Novartis, Regeneron, Sanofi and Teva, outside the submitted work, and is a member of the GOLD Science Committee. Michael Hyland has received personal fees from Novartis and GSK. Stephen T Holgate is a co-founder of Synairgen Research, owns shares in the company, and has received personal fees as a Non-Executive Director and Consultant of Synairgen Research outside of the submitted work. Francis Appiagyei, Emma-Jane Roberts, Megan Preston, Marije van Melle and Victoria Carter are employees of Optimum Patient Care who funded this study. David Price has board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermofisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp, which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. Michael Hyland reports personal fees from GSK, outside the submitted work. Pam Young and Tony Megaw are employees of Wellbeing Software. The remaining authors report no conflicts of interest., (© 2021 Jones et al.)
Published: 2021
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17. Persistence of Eosinophilic Asthma Endotype and Clinical Outcomes: A Real-World Observational Study.

Author: Tran TN, Kerkhof M, Carter V, and Price DB
Abstract: Purpose: Eosinophil count elevations are predictive of adverse outcomes in patients with asthma, yet little is known regarding longitudinal eosinophil patterns and their association with clinical outcomes. The goal of this study was to assess associations between longitudinal persistence of eosinophil elevations and both clinical outcomes and health care resource utilization (HCRU)., Methods: Data were extracted from 2 databases in the United Kingdom. Patients included were aged ≥13 years, had active asthma, and had ≥3 blood eosinophil count (BEC) recordings. Patients were categorized by BEC as: never high (all BEC ≤300 cells/µL), intermittently high (≥1 BEC >300 cells/µL but <75% of BEC >300 cells/µL), or persistently high (≥75% of BEC >300 cells/µL). Asthma exacerbations, asthma control (risk domain, overall, and full), and HCRU were evaluated for 12 months after the last BEC., Results: The study population comprised 148,021 patients. Persistently high, intermittently high, and never high eosinophil patterns were detected in 13.6%, 40.5%, and 45.9% of patients, respectively. Patients with ≥1 elevated BEC were at greater risk for severe asthma exacerbations, regardless of whether the elevation was persistent (rate ratio [RR]: 1.28 [95% CI 1.24-1.33]; P < 0.001) or intermittent (RR: 1.24 [95% CI 1.21-1.27]; P < 0.001), compared with patients with no eosinophil elevations. Full asthma control was achieved by <25% of patients across eosinophil pattern groups, and HCRU did not appreciably differ, although patients with persistently high BEC had the shortest hospital stay duration among the groups., Conclusion: These data suggest that elevated blood eosinophils, regardless of persistency, signify increased risk of severe asthma exacerbations., Competing Interests: Trung N Tran is an employee of AstraZeneca. Marjan Kerkhof was an employee of the Observational and Pragmatic Research Institute at the time of the study. Victoria Carter reports grants from Observational and Pragmatic Research Institute, during the conduct of the study. David B Price has board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Thermofisher, Zentiva (Sanofi Generics); consultancy agreements with Airway Vista Secretariat, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Pfizer, Strategic North Limited, Synapse Research Management Partners S.L, Talos Health Solutions, Teva Pharmaceuticals, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Merck, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore), owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. The authors report no other conflicts of interest in this work., (© 2021 Tran et al.)
Published: 2021
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18. Maximizing Adherence and Gaining New Information For Your Chronic Obstructive Pulmonary Disease (MAGNIFY COPD): Study Protocol for the Pragmatic, Cluster Randomized Trial Evaluating the Impact of Dual Bronchodilator with Add-On Sensor and Electronic Monitoring on Clinical Outcomes.

Author: Price D, Jones R, Pfister P, Cao H, Carter V, Kemppinen A, Holzhauer B, Kaplan A, Clark A, Halpin DMG, Pinnock H, Chalmers JD, van Boven JFM, Beeh KM, Kostikas K, Roche N, Usmani O, and Mastoridis P
Abstract: Background: Poor treatment adherence in COPD patients is associated with poor clinical outcomes and increased healthcare burden. Personalized approaches for adherence management, supported with technology-based interventions, may offer benefits to patients and providers but are currently unproven in terms of clinical outcomes as opposed to adherence outcomes., Methods: Maximizing Adherence and Gaining New Information For Your COPD (MAGNIFY COPD study), a pragmatic cluster randomized trial, aims to evaluate the impact of an adherence technology package (interventional package), comprising an adherence review, ongoing provision of a dual bronchodilator but with an add-on inhaler sensor device and a connected mobile application. This will compare time to treatment failure and other clinical outcomes in patients identified at high risk of exacerbations with historic poor treatment adherence as measured by prescription collection to mono/dual therapy over one year (1312 patients) versus usual care. Treatment failure is defined as the first occurrence of one of the following: (1) moderate/severe COPD exacerbation, (2) prescription of triple therapy (inhaled corticosteroid/long-acting β 2 -agonist/long-acting muscarinic antagonist [ICS/LABA/LAMA]), (3) prescription of additional chronic therapy for COPD, or (4) respiratory-related death. Adherence, moderate/severe exacerbations, respiratory-related healthcare resource utilization and costs, and intervention package acceptance rate will also be assessed. Eligible primary care practices (N=176) participating in the Optimum Patient Care Quality Improvement Program will be randomized (1:1) to either adherence support cluster arm (suitable patients already receiving or initiated Ultibro ® Breezhaler ® [indacaterol/glycopyrronium] will be offered interventional package) or the control cluster arm (suitable patients continue to receive usual clinical care). Patients will be identified and outcomes collected from anonymized electronic medical records within the Optimum Patient Care Research Database. On study completion, electronic medical record data will be re-extracted to analyze outcomes in both study groups., Registration Number: ISRCTN10567920., Conclusion: MAGNIFY will explore patient benefits of technology-based interventions for electronic adherence monitoring., Competing Interests: David Price has board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Thermofisher; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Merck, Zentiva (Sanofi Generics), Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; personal fees from Airway Vista Secretariat, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L, Talos Health Solutions, WebMD Global LLC, outside the submitted work; and was an expert witness for GlaxoSmithKline. Rupert Jones declares grants from Astra Zeneca, GlaxoSmithKline and Novartis and personal fees for consultancy, speaker’s fees or travel support from Astra Zeneca, Boehringer Ingelheim, Glaxo Smith Kline, Novartis, Nutricia and OPRI. Victoria Carter is an employee of the study sponsor Observational & Pragmatic Research International Ltd (OPRI), the study sponsor, which has conducted paid research in respiratory disease on behalf of the following other organizations in the past 5 years: Aerocrine, AKL Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Orion, Sanofi, Takeda and Teva. Alan Kaplan received fee for advisory board or speakers bureau for Astra Zeneca, Boehringer Ingelheim, Covis, GSK, Merck Frosst, Pfizer, Purdue, Novartis, Sanofi, Teva, Trudel. David MG Halpin has received personal fees from Aerogen, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Pfizer and Sanofi, and non-financial support from Boehringer Ingelheim and Novartis. Anu Kemppinen and Allan Clark have nothing to disclose. Hilary Pinnock was paid an honorarium for writing an on-line piece on supported self-management for Teva website. She is involved with several professional or educational organisations which receive multi-company sponsorship. Job van Boven receives funding from the European Commission to Chair the European Network to Advance Best practices & technoLogy on medication adherencE (COST Action CA19132, ENABLE). His institution (Medication Adherence Expertise Center of the northern Netherlands, MAECON, University Medical Center Groningen, Groningen, the Netherlands) has received consultancy fees, speaking fees, and/or research grants from AstraZeneca, Boehringer Ingelheim, Chiesi, eLucid mHealth, Menarini, Novartis, Teva and Trudell Medical related to medication adherence but all unrelated to this study. Kai M. Beeh declares personal or institutional compensations from the following in the past 5 years: Kai Beeh is a full time employee of insaf Respiratory Research Institute. The institution has received compensation for services on advisory boards or consulting for AstraZeneca, Berlin Chemie, Boehringer, Chiesi, Cytos, GSK, Mundipharma, Novartis, Pohl Boskamp, Sanofi, Zentiva. The institution has received compensation for speaker activities in scientific meetings supported by AstraZeneca, Berlin Chemie, Boehringer, ERT, GSK, Novartis, Pfizer, Pohl Boskamp, Sanofi, Takeda. The institution has further received compensation for design and performance of clinical trials from AstraZeneca, Boehringer, GSK, Infinity, Mundipharma, Novartis, Parexel, Pearl Therapeutics, Pfizer, Revotar, Teva, Sterna, and Zentiva. Konstantinos Kostikas was an employee and shareholder of Novartis Pharma AG until October 31, 2018. He have received honoraria for presentations and consultancy fees from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Menarini, Novartis and Sanofi; his department has received funding and grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Innovis, ELPEN, GSK, Menarini, Novartis and NuvoAir. Nicolas Roche reports research grants from Boehringer Ingelheim, Novartis, Pfizer and personal fees for consultancy, advisory boards, lectures and education, participation to steering committees from Boehringer Ingelheim, Novartis, Pfizer, Teva, GSK, AstraZeneca, Chiesi, Sanofi, Trudell, Zambon. James Chalmers reports grants and personal fees from AstraZeneca, grants and personal fees from Boehringer Ingelheim, personal fees from Chiesi, grants and personal fees from Gilead Sciences, grants and personal fees from GlaxoSmithKline, grants and personal fees from Novartis, personal fees from Zambon, from null, outside the submitted work; Dr. Chalmers reports grants and personal fees from AstraZeneca, grants and personal fees from Boehringer Ingelheim and Insmed, personal fees from Chiesi, grants and personal fees from Gilead Sciences, grants and personal fees from GlaxoSmithKline, grants and personal fees from Novartis, personal fees from Zambon, personal fees from Janssen, outside the submitted work. Omar Usmani reports grants and personal fees from AstraZeneca, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Chiesi, grants and personal fees from GlaxoSmithKline, personal fees from Napp, personal fees from Mundi Pharma, personal fees from Sandoz, personal fees from Takeda, grants from Edmond pharma, personal fees from Cipla, personal fees from Covis, personal fees from Novartis, personal fees from Mereo BioPharma, personal fees from Orion, personal fees from Menarini, personal fees from Deva, personal fees from Roche, personal fees from, Trudel, personal fees from UCB outside the submitted work. Björn Holzhauer, Pascal Pfister, Hui Cao and Paul Mastoridis are employees of Novartis and holds stock in Novartis Pharma AG. The authors report no other conflicts of interest in this work., (© 2021 Price et al.)
Published: 2021
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19. A Comparison of the Real-Life Clinical Effectiveness of the Leading Licensed ICS/LABA Combination Inhalers in the Treatment for COPD.

Author: Ming SWY, Haughney J, Ryan D, Small I, Lavorini F, Papi A, Singh D, Halpin DMG, Hurst JR, Patel S, Ochel M, Kocks J, Carter V, Hardjojo A, and Price DB
Subjects: Administration, Inhalation, Cohort Studies, Drug Combinations, Formoterol Fumarate therapeutic use, Humans, Nebulizers and Vaporizers, Treatment Outcome, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive drug therapy
Abstract: Introduction: The Fostair® 100/6 (BDP/FF) pressurized metered-dose inhaler, delivering an extrafine formulation, is licensed for asthma and COPD in the UK. However, its real-life effectiveness for COPD has not been evaluated. This study compared the clinical effectiveness of BDP/FF against other licensed ICS/LABA combination inhalers: the Seretide® Accuhaler® (FP/SAL) and the Symbicort® Turbohaler® (BUD/FF)., Methods: A matched historical cohort study was conducted using records of patients with diagnostic codes for COPD from the Optimum Patient Care Research Database (OPCRD). Patients who had received BDP/FF as their first ICS/LABA were matched 1:1 with patients who had received FP/SAL or BUD/FF, resulting in two matched comparisons. Additional analysis was conducted on patients who had never had diagnostic codes for asthma. Noninferiority in terms of the proportion of patients with moderate/severe COPD exacerbations on the different inhalers in the following year was assessed. Noninferiority was achieved if the upper CI limit were ≤1.2., Results: This study included 537 and 540 patient pairs in the BDP/FF vs FP/SAL cohort and the BDP/FF vs BUD/FF cohort, respectively. The proportion of patients with COPD exacerbations in the BDP/FF group was not significantly different from either the FP/SAL (68.7% vs 70.2%, AOR 0.89, 95% CI 0.67-1.19) or BUD/FF group (68.5% vs 69.4%, AOR 0.79, 95% CI 0.58-1.08). Noninferiority of BDP/FF in preventing COPD exacerbations was fulfilled in both comparisons. In patients without asthma, BDP/FF was also noninferior to BUD/FF (proportion with COPD exacerbations, 67.8% vs 64.7%, AOR 0.79, 95% CI 0.51-1.1997). Additionally, a significantly lower proportion of patients prescribed BDP/FF had COPD exacerbations than FP/SAL (64.8% vs 73.7%, AOR 0.64 95% CI 0.43-0.96)., Conclusion: Initiating ICS/LABA treatment of COPD with extrafine-formulation BDP/FF was noninferior in preventing moderate/severe exacerbations compared to FP/SAL and BUD/FF., Competing Interests: David Price has board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, and Teva Pharmaceuticals, consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance, grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute) from AKL Research and Development, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Circassia, Mylan, Mundipharma, Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, and UK National Health Service, Zentiva (Sanofi Generics), has received payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, and Teva Pharmaceuticals, payment for manuscript preparation from Mundipharma, Teva Pharmaceuticals, payment for the development of educational materials from Mundipharma, Novartis, payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Circassia, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals, funding for patient enrolment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, Zentiva (Sanofi Generics), stock/stock options from AKL Research and Development, which produces phytopharmaceuticals, owns 74% of the social enterprise Optimum Patient Care (Australia and UK), 74% of Observational and Pragmatic Research Institute (Singapore), has a 5% shareholding in TimeStamp, which develops adherence-monitoring technology, is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation Programme and Health Technology Assessment, and was an expert witness for GlaxoSmithKline. Dermot Ryan has received support to attend meetings, delivered educational events on behalf of, or provided consultancy to AstraZeneca, Chiesi, CGS, Teva, Trudell Medical, Novartis, BI, Optimum Patient Care, Meda/Mylan, Stallergenes, and GSK, and also reports personal fees from Optimum Patient Care, GSK, and Regeneron and nonfinancial support from Novartis, AstraZeneca, BI, and Mylan outside the submitted work. John R Hurst has received personal payment and payment to his institution (UCL), including research grants, reimbursement for advisory work and educational activities, and support to attend meetings from pharmaceutical companies that make medicines to treat COPD, which includes AstraZeneca, Boehringer Ingelheim, Chiesi and Novartis. There is no direct conflict of interest with this work. Dave Singh acquired sponsorship to attend international meetings, honoraria for lecturing or attending advisory boards, or research grants from various pharmaceutical companies, including Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Genentech, GlaxoSmithKline, Glenmark, Johnson and Johnson, Merck, Mundipharma, NAPP, Novartis, Pfizer, Peptinnovate, Pulmatrix, Skypharma, Takeda, Teva, Therevance, and Verona. Federico Lavorini has received in the last 5 years honoraria for lecturing or attending advisory boards from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Hikma, Menarini International, Mundipharma, Novartis, Orion Pharma, Teva, and Trudell International. David MG Halpin has received sponsorship to attend international meetings and honoraria for lecturing, attending advisory boards, and preparing educational materials from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Pfizer, Sanofi, and Teva. John Haughney reports grants and research supports from AstraZeneca and Boehringer Ingelheim and honoraria or consultation fees from AstraZeneca, Boehringer Ingelheim, Cipla, Chiesi, and Teva. Alberto Papi has received grants, personal fees, and nonfinancial support from AstraZeneca, Chiesi Farmaceutici, GlaxoSmithKline, Boehringer Ingelheim, Edmondpharma, Foondazione Maugeri, Merck Sharp & Dohme, Menarini, Novartis, Zambon, Teva, Pfizer, Takeda, Sanofi/Regeneron, Roche, and Mundipharma. Janwillem Kocks reports grants and personal fees from AstraZeneca, grants and personal fees from Boehringer Ingelheim, grants from Chiesi, grants and personal fees from GSK, grants and personal fees from Novartis, and grants from Mundi Pharma and Teva outside the submitted work. Iain Small reports personal fees from Chiesi, AstraZeneca, and NAPP, and other from BMJ Group and Pfizer outside the submitted work. Shish Patel and Matthias Ochel are employed by Chiesi, the sponsor of the study. Simon Wan Yau Ming, Victoria Carter, and Antony Hardjojo are employees of the Observational and Pragmatic Research Institute, which has conducted paid research on respiratory disease on behalf of the following organizations in the past 5 years: Anaxys, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Circassia (formerly Aerocrine), GlaxoSmithKline, Harvey Walsh, Mapi, Morningside Healthcare, Mundipharma, Mylan (formerly Meda), Napp, Novartis, Orion, Plymouth University, Regeneron, Respiratory Effectiveness Group, Roche, Sanofi, Takeda, Teva, University of East Anglia, and Zentiva (a Sanofi company). The authors report no other conflicts of interest in this work., (© 2020 Ming et al.)
Published: 2020
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20. The Long-Term Burden of COPD Exacerbations During Maintenance Therapy and Lung Function Decline.

Author: Kerkhof M, Voorham J, Dorinsky P, Cabrera C, Darken P, Kocks JWH, Sadatsafavi M, Sin DD, Carter V, and Price DB
Subjects: Aged, Disease Progression, Female, Forced Expiratory Volume, Humans, Lung, Male, Respiratory Function Tests, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive drug therapy, Pulmonary Disease, Chronic Obstructive epidemiology
Abstract: Introduction: Early identification of preventable risk factors of COPD progression is important. Whether exacerbations have a negative impact on disease progression is largely unknown. We investigated whether the long-term occurrence of exacerbations is associated with lung function decline at early stages of COPD., Methods: Patients diagnosed with mild/moderate COPD (obstruction and FEV 1 % predicted 50-90%), aged ≥35 years, and a smoking history, who had ≥6 years of UK electronic medical records after initiation of maintenance therapy were studied. Multilevel mixed-effect linear regression was performed to determine the association between the count of any year in which the patient had ≥1 exacerbation over a 6-year period and FEV 1 decline, adjusted for sex, age, anthropometrics and smoking habits. Exacerbations were defined as any prescription for an acute oral corticosteroid course and/or lower respiratory-related antibiotics and/or any COPD-related emergency or inpatient hospitalization., Results: Of 11,337 patients included (mean age 65 years; 49% female) 31.6%, 23.3%, 16.6%, 11.6%, 8.1%, 5.3% and 3.4% had 0, 1, 2, 3, 4, 5 and 6 years with ≥1 exacerbation. The mean annual FEV 1 decline accelerated by 1.50 mL/year (95% Confidence Interval 1.02; 1.98) with every additional year with ≥1 exacerbation from 31.0 mL/year in subjects without any exacerbation to 40.0 mL/year in patients experiencing ≥1 exacerbation every year. Patients with more years with ≥1 exacerbation had a lower mean FEV 1 at first diagnosis: 14.7 mL (11.7; 17.8) lower with every additional year with exacerbations. When counting years with ≥2 exacerbations, greater effects were observed (2.19 [1.50; 2.88] mL/year excess decline per year with ≥2 exacerbations; 16.5 mL [12.1; 20.8] lower FEV 1 at diagnosis)., Conclusion: Patients who experienced a greater exacerbation burden after initiation of maintenance therapy had worse lung function at diagnosis and a more rapid lung function decline thereafter, which emphasizes the need for better treatment strategies., Competing Interests: Marjan Kerkhof, Jaco Voorham, Victoria Carter and Janwillem W. H. Kocks are employees of the Observational and Pragmatic Research Institute, which conducted this study and which has conducted paid research in respiratory disease on behalf of the following other organizations in the past 5 years: Aerocrine, AKL Research and Development Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp, Novartis, Orion, Takeda, Teva, Zentiva (a Sanofi company). David B Price has board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Mundipharma, Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from Aerocrine, AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Mylan, Mundipharma, Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service, Zentiva (Sanofi Generics); payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Skyepharma, Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundipharma, Napp, Novartis, Teva Pharmaceuticals; funding for patient enrolment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, Zentiva (Sanofi Generics); stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment. Claudia Cabrera, Paul Dorinsky and Patrick Darken are employees of AstraZeneca. Don D. Sin has received honoraria for speaking engagements from Boehringer Ingelheim (BI), AstraZeneca (AZ), Merck, and Novartis. He has received research funding from Merck, BI and AZ for work related to COPD and has sat on advisory boards of AZ, BI and Sanofi. Mohsen Sadatsafavi has received honoraria for speaking engagements from Boehringer Ingelheim, AstraZeneca, and GlaxoSmithKline. The authors report no other conflicts of interest in this work., (© 2020 Kerkhof et al.)
Published: 2020
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21. Comparison of clinical baseline characteristics between Asian and Western COPD patients in a prospective, international, multicenter study.

Author: Kim KY, Miravitlles M, Sliwinski P, Costello R, Carter V, Tan J, Lapperre TS, Alcazar B, Gouder C, Esquinas C, García-Rivero JL, Kemppinen A, Tee A, Roman-Rodríguez M, Soler-Cataluña JJ, Price D, and Rhee CK
Subjects: Aged, Asian People statistics & numerical data, Body Mass Index, Cohort Studies, Female, Global Health ethnology, Global Health statistics & numerical data, Humans, Male, Middle Aged, Prospective Studies, Risk Factors, Severity of Illness Index, White People statistics & numerical data, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive ethnology, Pulmonary Disease, Chronic Obstructive physiopathology, Respiratory Function Tests methods, Respiratory Function Tests statistics & numerical data
Abstract: We aimed to compare clinical characteristics between Asian and Western chronic obstructive pulmonary disease (COPD) patients. This was a sub-analysis of an international, multicenter, prospective cohort study. Asian patients were enrolled in Singapore and South Korea. Western patients were enrolled in Spain, Poland, Ireland, the United Kingdom, and Malta. A total of 349 patients were analyzed. Among them, 110 (32%) patients were Asian and 239 (68%) Western. Male sex was more predominant in Asian than in Western (95% versus 63%, respectively; P <0.01). Body mass index was significantly lower in Asian (23.5 versus 27.1; P <0.01). The proportion of patients with a history of exacerbation was lower in Asian (12% versus 64%; P <0.01). Although patients were enrolled by same inclusion criteria, there were several differences between Asian and Western COPD patients. Our study has shown unbiased real-world differences between Asian and Western COPD patients. Since prospective follow-up study is currently ongoing, the result of this study can be fundamental base of future analysis., Competing Interests: Dr Marc Miravitlles received speaker and/or consulting and personal fees from AstraZeneca, Bial, Boehringer Ingelheim, Chiesi, Cipla, CSL Behring, Laboratorios Esteve, Ferrer, Gebro Pharma, GlaxoSmithKline, Grifols, Menarini, Mereo Biopharma, Novartis, pH Pharma, Rovi, TEVA, Verona Pharma and Zambon, and research grants from GlaxoSmithKline and Grifols outside the submitted. Professor Pawel Sliwinski received speaker fees and non-financial support from Boehringer Ingelheim, AstraZeneca, Chiesi, GlaxoSmithKline, Grifols, Novartis, Roche and Teva, and consulting fees from Boehringer Ingelheim, GlaxoSmithKline, Chiesi, Grifols, Novartis, and Roche, outside the submitted work. Dr CK Rhee received consulting/lecture fees from MSD, AstraZeneca, Novartis, GSK, Takeda, Mundipharma, Sandoz, Boehringer-Ingelheim, and Teva-Handok. Dr Richard Costelloe has board membership with GSK, Aerogen, Novartis, and Teva Pharmaceuticals; consultancy agreements with, Aerogen, GlaxoSmithKline, Novartis, Teva Pharmaceuticals, and Vitalograph as well as grants and unrestricted funding for investigator-initiated studies from Vitalograph, Aerogen and GlaxoSmithKline. Dr Bernardino Alcazar reports personal fees grants, and non-financial support from Novartis AG, Boehringer-Ingelheim, GSK, personal fees from AztraZeneca, grants and personal fees from Laboratorios Menarini, Laboratorios Rovi, Laboratorios Ferrer, outside the submitted work, in addition, he has a patent WO2018/215686A1 issued. Dr Augustine Tee received research fund from The Respiratory Effectiveness Group, during the conduct of the study; has participated as a member of the local COPD advisory board for AstraZeneca, GlaxoSmithKline, Bayer, Takeda, and Novartis, and has received meeting/conference travel grants from Boehringer Ingelheim, Novartis, AstraZeneca, and GlaxoSmithKline. Ms Victoria Carter reports funding this study by an unrestricted grant from Novartis AG, during the conduct of the study; also she is an employee of the Observational and Pragmatic Research Institute Pte Ltd (OPRI), and Optimum Patient Care. Dr Juan José Soler-Cataluña has received speaker fees from AstraZeneca, grants, personal fees, non-financial support from Boehringer Ingelheim, non-financial support from Chiesi, Esteve, Ferrer, GSK, Menarini, Novartis, and Pfizer, and consulting fees from AirLiquide, Boehringer Ingelheim, Chiesi, GSK, AstraZeneca, Ferrer, and Novartis outside the submitted work. Professor David Price has board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Mundipharma, Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from Aerocrine, AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Mylan, Mundipharma, Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service, Zentiva (Sanofi Generics); payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Skyepharma, Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundipharma, Napp, Novartis, Teva Pharmaceuticals; funding for patient enrolment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, Zentiva (Sanofi Generics); stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment. Dr Miguel Roman-Rodríguez has received speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Gebro Pharma, GlaxoSmithKline, Menarini, Mundipharma, Novartis, Pfizer, and Teva, and consulting/personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Novartis outside the submitted work. The authors report no other conflicts of interest in this work.
Published: 2019
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22. Physiological predictors Of peak inspiRatory flow using Observed lung function resultS (POROS): evaluation at discharge among patients hospitalized for a COPD exacerbation.

Author: Price DB, Yang S, Ming SWY, Hardjojo A, Cabrera C, Papaioannou AI, Loukides S, Kritikos V, Bosnic-Anticevich SZ, Carter V, and Dorinsky PM
Subjects: Administration, Inhalation, Aged, Aged, 80 and over, Bronchodilator Agents administration & dosage, Comorbidity, Dry Powder Inhalers, Equipment Design, Feasibility Studies, Female, Forced Expiratory Volume, Greece epidemiology, Humans, Lung drug effects, Male, Middle Aged, Predictive Value of Tests, Prevalence, Pulmonary Disease, Chronic Obstructive drug therapy, Pulmonary Disease, Chronic Obstructive epidemiology, Pulmonary Disease, Chronic Obstructive physiopathology, Retrospective Studies, Severity of Illness Index, Vital Capacity, Airway Resistance drug effects, Lung physiopathology, Patient Admission, Patient Discharge, Pulmonary Disease, Chronic Obstructive diagnosis, Spirometry
Abstract: Background: Peak inspiratory flow (PIF) as generated through the resistance of a dry powder inhaler (DPI) device is a critical patient-dependent maneuver impacting the success of DPI medication delivery. Despite its importance, it is not routinely measured in clinical practice. Little is currently known about the relationship, if any, between PIF through DPI devices, routine spirometry and disease outcomes., Aim: The aim of this study was to identify potential predictors of PIF for different DPIs from spirometric parameters and patient characteristics and explore the association between PIF and follow-up events., Patients and Methods: A retrospective observational study at discharge among patients hospitalized for a COPD exacerbation at Attikon hospital, Athens, Greece. Spirometry was performed using an Easy on-PC™ spirometer. PIF was measured through four DPI resistances using the In-Check™ DIAL. Regression analyses were used to investigate the association between PIF through resistances and spirometric parameters obtained at discharge, comorbidities and demographic parameters., Results: Forty-seven COPD patients (mean [±SD], age 71 [±9] years, 72% males, 51% current smokers) were included in this study. Overall, 85% and 15% were classified as GOLD (2017) groups D and C, respectively. Most prevalent comorbidities were hypertension (70%) and cardiovascular disease (53%). In the final regression model, higher PIF was significantly associated with the following: higher FEV 1 and % predicted peak expiratory flow (PEF) for Turbohaler ® ( R -squared value 0.374); higher FEV 1 and diagnosis of gastroesophageal reflux disease (GERD) for Aerolizer ® ( R -squared value 0.209) and higher FEV 1 , younger age and diagnosis of ischemic heart disease (IHD) for Diskus ® ( R -squared value 0.350). However, R -squared values for all three devices were weak (<0.4)., Conclusion: The study did not provide evidence to support the use of surrogate measurements for PIF through device resistance, which could assist in determining the appropriateness of inhaler device type. Although PIF measurement is feasible in patients at discharge and could be a valuable addition to the standard of care in COPD management, it needs to be measured directly., Competing Interests: Disclosure David B Price has board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Mundipharma, Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from Aerocrine, AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Mylan, Mundipharma, Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service, Zentiva (Sanofi Generics); payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Skyepharma, Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundipharma, Napp, Novartis, Teva Pharmaceuticals; funding for patient enrolment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, Zentiva (Sanofi Generics); stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment. David B Price is owner and managing director of Observational and Pragmatic Research Institute Pte Ltd. Vicky Kritikos has received honoraria from AstraZeneca, GlaxoSmithKline and Pfizer. Sinthia Z Bosnic-Anticevich has received honoraria from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mundipharma and Teva Pharmaceuticals for her contribution to advisory boards/key international expert forum. Victoria Carter, Sen Yang, Antony Hardjojo and Simon Wan Yau Ming are employees of the Observational and Pragmatic Research Institute Pte Ltd, which has conducted paid research in respiratory disease on behalf of the following organizations in the past 5 years: Anaxys, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Circassia (formerly Aerocrine), Glaxo-SmithKline, Harvey Walsh, Mapi, Morningside Healthcare, Mundipharma, Mylan (formerly Meda), Napp, Novartis, Orion, Plymouth University, Regeneron, Respiratory Effectiveness Group, Roche, Sanofi, Takeda, Teva, University of East Anglia, Zentiva (a Sanofi company). Paul M Dorinsky is an employee of Pearl – a member of the AstraZeneca Group. Claudia Cabrera is an employee of AstraZeneca. Andriana I Papaioannou and Stelios Loukides declare no relevant conflicts of interest. The authors report no other conflicts of interest in this work.
Published: 2018
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23. Real-life treatment of rhinitis in Australia: a historical cohort study of prescription and over-the-counter therapies for patients with and without additional respiratory disease.

Author: Price DB, Smith PK, Harvey RJ, Carney AS, Kritikos V, Bosnic-Anticevich SZ, Christian L, Skinner D, Carter V, and Durieux AM
Abstract: Background: The aim of the study was to explore rhinitis therapy purchases in different Australian regions for patients with and without additional respiratory disease, using both doctor's prescriptions and over-the-counter (OTC) medications., Patients and Methods: It was a historical cohort study of pharmacy-related claims that included prescription or OTC rhinitis therapy, with or without asthma/COPD therapy, from January 2013 to December 2014., Results: Overall, 4,247,193 prescription and OTC rhinitis treatments were purchased from 909 pharmacies over a calendar year; the majority were single-therapy purchases for rhinitis only patients. More multiple-therapy was purchased for rhinitis and asthma/COPD patients (4.4%) than for rhinitis only patients (4.0%), with a greater proportion purchased in VIC, SA and TAS (4.7% of rhinitis only patients and 4.5% of rhinitis and asthma/COPD patients) than in other areas. Dual therapy of oral antihistamine (OAH) and intranasal corticosteroid (INS) were the most frequently purchased multiple-therapy, with higher purchasing rates for rhinitis and asthma/COPD patients (2.6%) than for rhinitis only patients (1.6%). The most frequently purchased single therapy was OAH (70.1% of rhinitis only patients and 57.3% of rhinitis and asthma/COPD patients). First-line INS therapy was more likely to be purchased for rhinitis and asthma/COPD patients (15.3% by prescription and 11.7% OTC) than for rhinitis only patients (5.0% by prescription and 9.2% OTC); however, geographical differences in the proportion of therapies purchased OTC were noted, with a lower proportion of OTC OAH and INS purchases in Queensland and the Northern Territory for patients with and without comorbid respiratory disease., Conclusion: Purchases of first-line INS therapy are more likely for patients with comorbid respiratory disease if they have received prescriptions and information/advice from their general practitioner. The study results indicate a need for patient information/education at the point-of-sale of OTC OAHs to enable patients to assess their nasal symptoms and receive treatment support from pharmacists. Greater availability to INSs in pharmacies as well as guidance from current guidelines and instruction in correct intranasal technique may also lead to greater uptake of INSs., Competing Interests: Disclosure David B Price has board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Mundipharma, Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, and Teva Pharmaceuticals; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals and Thera-vance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from Aerocrine, AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Mylan, Mundipharma, Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service and Zentiva (Sanofi Generics); payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Skyepharma and Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma and Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma and Novartis; payment for travel/accommodation/meeting expenses from Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundipharma, Napp, Novartis and Teva Pharmaceuticals; funding for patient enrolment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals and Zentiva (Sanofi Generics); stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme. Pete K Smith has received honoraria from Astra-Zeneca, GlaxoSmithKline, MEDA Pharmaceuticals and Mundipharma. Richard John Harvey is a consultant for Medtronic, NeilMed and Olympus, and has received honoraria from Seqirus and grant support from MEDA Pharmaceuticals, NeilMed and Stallergenes. A Simon Carney is a consultant for Olympus and Smith & Nephew and has received honoraria from MEDA Pharmaceuticals. Vicky Kritikos has received honoraria from AstraZeneca, GlaxoSmithKline and Pfizer. Sinthia Z Bosnic-Anticevich has received honoraria from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mundipharma and TEVA Pharmaceuticals for her contribution to advisory boards/key international expert forum. Victoria Carter is an employee of Observational and Pragmatic Research Institute Pte Ltd, which has conducted paid research in respiratory disease on behalf of the following organizations in the past 5 years: Aerocrine, AKL Research and Development Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Orion, Takeda, Teva and Zentiva (a Sanofi company). Alice MS Durieux was an employee of Observational and Pragmatic Research Institute Pte Ltd. The authors report no other conflicts of interest in this work.
Published: 2018
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24. Seasonal patterns of oral antihistamine and intranasal corticosteroid purchases from Australian community pharmacies: a retrospective observational study.

Author: Carney AS, Price DB, Smith PK, Harvey R, Kritikos V, Bosnic-Anticevich SZ, Christian L, Skinner DA, Carter V, and Durieux AM
Abstract: Purpose: To explore patterns in the purchase of prescription and over-the-counter (OTC) oral antihistamines (OAHs) and intranasal corticosteroids (INCSs) by patients, from pharmacies in different geographical regions of Australia., Patients and Methods: Retrospective observational study using a database containing anonymous pharmacy transaction data from 20.0% of the pharmacies in Australia that link doctor prescriptions and OTC information. Pharmacy purchases of at least one prescription or OTC rhinitis treatment during 2013 and 2014 were assessed., Results: In total, 4,247,193 prescription and OTC rhinitis treatments were purchased from 909 pharmacies over 12 months. Of treatments purchased, 75.9% were OAHs and 16.6% were INCSs. OTC purchases of both treatments exceeded purchases through prescription. OTC OAHs purchasing patterns were seasonal and almost identical in the Australian Capital Territory, Victoria, Western Australia, South Australia, and New South Wales, and similar seasonal patterns for OTC INCSs were noted in most regions except for South Australia and Tasmania. Prescription purchasing patterns of both OAHs and INCSs remained unchanged throughout the year in most regions., Conclusion: This large-scale retrospective observational study identified seasonal purchasing patterns of OTC and prescription OAHs and INCSs in a real-world setting. It highlighted that seasonality only affects OTC purchasing patterns of OAHs and INCSs across Australia and that practitioner prescribing remains unchanged, suggesting that it is only for persistent disease., Competing Interests: Disclosure A Simon Carney is a consultant for Olympus and Smith and Nephew and has received honoraria from MEDA Pharmaceuticals. David B Price has board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from UK National Health Service, British Lung Foundation, Aerocrine, AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, Pfizer, Respiratory Effectiveness Group, Takeda, Teva Pharmaceuticals, Zentiva, and Theravance; payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Meda, Merck, Mundipharma, Novartis, Pfizer, Skyepharma, Takeda, and Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma and Teva Pharmaceuticals; payment for the development of educational materials from Novartis and Mundipharma; payment for travel/accommodation/meeting expenses from Aerocrine, Boehringer Ingelheim, Mundipharma, Napp, Novartis, Teva Pharmaceuticals, and AstraZeneca; funding for patient enrolment or completion of research from Chiesi, Teva Pharmaceuticals, Zentiva, and Novartis; stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd, UK, and 74% of Observational and Pragmatic Research Institute Pte Ltd, Singapore; and is peer reviewer for grant committees of the Medical Research Council, Efficacy and Mechanism Evaluation programme, and Health Technology Assessment. Pete Smith has received honoraria from AstraZeneca, GlaxoSmithKline, MEDA Pharmaceuticals, and Mundipharma. Richard Harvey is a consultant for Medtronic, Neilmed, and Olympus, he has received honoraria from Sequiris and grant support from MEDA Pharmaceuticals, Neilmed and Stallergenes. Vicky Kritikos has received honoraria from AstraZeneca, GlaxoSmithKline, and Pfizer. Sinthia Bosnic-Anticevich has received honoraria from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mundipharma, and TEVA Pharmaceuticals for her contribution to advisory boards/key international expert forum. Alice Durieux was an employee of Observational and Pragmatic Research Institute, which has conducted paid research in respiratory disease on behalf of UK National Health Service, British Lung Foundation, Aerocrine, AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, Chiesi, MEDA Pharmaceuticals, Mundipharma, Napp, Novartis, Pfizer, Respiratory Effectiveness Group, Takeda, TEVA Pharmaceuticals, Theravance, and Zentiva. The other authors report no conflicts of interest in this work.
Published: 2017
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25. Medication-related costs of rhinitis in Australia: a NostraData cross-sectional study of pharmacy purchases.

Author: Smith P, Price D, Harvey R, Carney AS, Kritikos V, Bosnic-Anticevich SZ, Christian L, Skinner D, Carter V, and Durieux AMS
Abstract: Purpose: There is a relative paucity of research regarding medication expenditure associated with multiple-therapy use for rhinitis in Australia. To describe 1) the nature and extent of multiple-therapy use for rhinitis in Australia using data on therapies purchased with prescription or over-the-counter (OTC) and 2) additional costs incurred by multiple-therapy use compared with intranasal corticosteroid (INCS) therapy alone., Patients and Methods: A retrospective observational study was carried out using a database containing anonymous pharmacy transaction data available from 20% of pharmacies in Australia that links doctor prescriptions and OTC purchase information. Pharmacy purchases of at least one prescription or OTC rhinitis treatment, with or without additional asthma/chronic obstructive pulmonary disease (COPD) therapy, by patients during 2013 and 2014 were assessed., Results: In total, 4,247,193 prescription and OTC rhinitis treatments were purchased from 909 pharmacies over 24 months. The majority of rhinitis therapy transactions were single-therapy purchases without additional asthma/COPD therapy. Of the single therapies purchased, 73% were oral antihistamines (OAHs) and 15% were INCS therapy. Dual-therapy purchases of INCSs and OAHs accounted for 40% of multiple-therapy purchases. Patients frequently purchased OAHs, nonsteroidal nasal sprays, and eye drops for allergic conjunctivitis alongside INCSs, resulting in higher financial costs (up to AU$21 per treatment episode) compared with INCS monotherapy., Conclusion: This study highlighted the significant burden posed on community pharmacy to address the needs of people with rhinitis symptoms, and the failure to translate the evidence that INCSs are the most effective monotherapy for moderate to severe and/or persistent rhinitis into clinical practice in light of the lack of evidence supporting combination of INCS and OAH therapy. Health care professional engagement, especially at the pharmacy level, will be extremely important if we wish to ensure that the purchase of rhinitis treatment is in accordance with guidelines and that their use is optimal., Competing Interests: Disclosure Pete Smith has received honoraria from AstraZeneca, Glaxo-SmithKline, Meda Pharmaceuticals, and Mundipharma. David Price has board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; consultancy with Almirall, Amgen, AstraZeneca, Boeh-ringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from UK National Health Service, British Lung Foundation, Aerocrine, AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, Pfizer, Respiratory Effectiveness Group, Takeda, Teva Pharmaceuticals, Zentiva, and Theravance; payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Meda, Merck, Mundipharma, Novartis, Pfizer, Skyepharma, Takeda, and Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma and Teva Pharmaceuticals; payment for the development of educational materials from Novartis and Mundipharma; payment for travel/accommodation/meeting expenses from Aerocrine, Boehringer Ingelheim, Mundipharma, Napp, Novartis, Teva Pharmaceuticals, and AstraZeneca; funding for patient enrollment or completion of research from Chiesi, Teva Pharmaceuticals, Zentiva, and Novartis; stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd, UK, and 74% of Observational and Pragmatic Research Institute Pte Ltd, Singapore; and is peer reviewer for grant committees of the Medical Research Council, Efficacy and Mechanism Evaluation Programme, and Health Technology Assessment. Richard Harvey is a consultant for Medtronic, Neilmed, and Olympus, and has received honoraria from Sequiris and grant support from Meda Pharmaceuticals, Neilmed, and Stallergenes. Andrew Simon Carney is a consultant for Olympus and Smith & Nephew, and has received honoraria from Meda Pharmaceuticals. Vicky Kritikos has received honoraria from AstraZeneca, GlaxoSmithKline, and Pfizer. Sinthia Z Bosnic-Anticevich has received honoraria from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mundipharma, and Teva Pharmaceuticals for her contribution to advisory boards/key international expert forum. Alice Marie Sybille Durieux has conducted paid research in respiratory disease in the past 5 years on behalf of Aerocrine, AKL Research and Development Ltd, Almirall, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda Pharmaceuticals, Mundipharma, Napp, Novartis, Orion, Takeda, Teva Pharmaceuticals, and Zentiva. The authors report no other conflicts of interest in this work.
Published: 2017
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25 results on '"Carter,Victoria"'

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2. 2. Research databases in Catalonia

3. Healthcare Resource Utilization Associated with Intermittent Oral Corticosteroid Prescribing Patterns in Asthma.

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18. Maximizing Adherence and Gaining New Information For Your Chronic Obstructive Pulmonary Disease (MAGNIFY COPD): Study Protocol for the Pragmatic, Cluster Randomized Trial Evaluating the Impact of Dual Bronchodilator with Add-On Sensor and Electronic Monitoring on Clinical Outcomes.

19. A Comparison of the Real-Life Clinical Effectiveness of the Leading Licensed ICS/LABA Combination Inhalers in the Treatment for COPD.

20. The Long-Term Burden of COPD Exacerbations During Maintenance Therapy and Lung Function Decline.

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22. Physiological predictors Of peak inspiRatory flow using Observed lung function resultS (POROS): evaluation at discharge among patients hospitalized for a COPD exacerbation.

23. Real-life treatment of rhinitis in Australia: a historical cohort study of prescription and over-the-counter therapies for patients with and without additional respiratory disease.

24. Seasonal patterns of oral antihistamine and intranasal corticosteroid purchases from Australian community pharmacies: a retrospective observational study.

25. Medication-related costs of rhinitis in Australia: a NostraData cross-sectional study of pharmacy purchases.

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