Search

Despite great advancements in the treatment of chronic airway diseases, improvements in morbidity and mortality have stalled in recent years. Asthma and chronic obstructive pulmonary disease are complex and heterogeneous diseases that require tailored management based on individual patient characteristics and needs. The Treatable Traits (TTs) approach aims to personalise and improve patient care through the identification and targeting of clinically relevant and modifiable pulmonary, extra-pulmonary and behavioural traits. In this article, we outline the rationale for TTs-based management and provide practical guidance for its application in primary care. To aid implementation, seven potential 'prime' traits are proposed: airflow obstruction, eosinophilic inflammation, adherence, inhaler technique, smoking, low body mass index/obesity and anxiety and depression-selected for their prevalence, recognisability and feasibility of use. Some of the key questions among healthcare professionals, that may be roadblocks to widespread application of a TTs model of care, are also addressed., (© 2024. The Author(s).)

The treatable traits approach is based on the recognition that the different clinical phenotypes of asthma and chronic obstructive airways disease (COPD) are a heterogeneous group of conditions with different underlying mechanisms and clinical manifestations, and that the identification and treatment of the specific clinical features or traits facilitates a personalised approach to management. Fundamentally, it recognises two important concepts. Firstly, that treatment for obstructive lung disease can achieve better outcomes if guided by specific clinical characteristics. Secondly, that in patients with a diagnosis of asthma, and/or COPD, poor respiratory health may also be due to numerous overlapping disorders that can present with symptoms that may be indistinguishable from asthma and/or COPD, comorbidities that might require treatment in their own right, and lifestyle or environmental factors that, if addressed, might lead to better control rather than simply increasing airways directed treatment. While these concepts are well accepted, how best to implement this personalised medicine approach in primary and secondary care within existing resource constraints remains uncertain. In this review, we consider the evidence base for this management approach and propose that the priority now is to assess different prototype templates for the identification and management of treatable traits in both asthma and COPD, in primary, secondary and tertiary care, to provide the evidence that will guide their use in clinical practice in different health care systems., (@ 2023 The Authors. Respirology published by John Wiley & Sons Australia, Ltd on behalf of Asian Pacific Society of Respirology.)

Objectives: To describe a transparent approach to planning a digital intervention for adolescents to self-manage their asthma using breathing retraining (BRT), based on an existing, effective adult intervention (BREATHE)., Methods: A theory-, evidence-, and Person-Based Approach was used to maximise the effectiveness and persuasiveness of the intervention. A scoping review and semistructured interviews with target intervention users (N = 18, adolescents aged 12-17 years with asthma and parents) were carried out to explore user perspectives, barriers, and facilitators towards the intended behaviours and potential intervention features. The combined evidence was used alongside and to inform theory-based activities and enabled iterative planning of the intervention., Results: The scoping review identified themes relating to user-specific self-management issues, content, education, training needs, and features for a digital intervention. Interviews elicited potential barriers to intended behaviours such as the anticipated embarrassment of using BRT and concerns around remaining calm. Facilitators included BRT delivered by adolescents who share experiences of asthma and information for performing exercises discreetly. Relevant theoretical frameworks ensured that appropriate psychological constructs were targeted. A behavioural analysis identified six intervention functions and thirty behaviour change techniques. Logic modelling mapped the programme theory and mechanisms, which aims to improve adolescent asthma-related quality of life., Conclusions: This study gives a transparent insight into the approach followed to plan a self-guided BRT intervention for adolescents and has led to identification of key behavioural issues, enabling relevant intervention content to be chosen. Insight has been given into adolescent perceptions of BRT, which facilitated development of the prototype intervention., (© 2022 The Authors. Pediatric Pulmonology published by Wiley Periodicals LLC.)

Rationale: Moderate to severe asthma is associated with impaired asthma control and quality of life (QoL) despite access to specialist care and modern pharmacotherapy. Breathing exercises (BrEX) improve QoL in incompletely controlled mild asthma, but impact in moderate to severe asthma is unknown. Objectives: To investigate the effectiveness of BrEX as adjuvant treatment on QoL in patients with uncontrolled moderate to severe asthma. Methods: Adult patients with incompletely controlled asthma attending respiratory specialist clinics were randomized to usual specialist care (UC) or UC and BrEX (UC + BrEX) with three individual physiotherapist-delivered sessions and home exercises. Primary outcome was asthma-related QoL (Mini-Asthma Quality of Life Questionnaire [Mini-AQLQ]) at 6 months on the basis of intention-to-treat analysis. Secondary outcomes: Mini-AQLQ at 12 months, lung function, 6-minute-walk test, physical activity level, Nijmegen Questionnaire, Hospital Anxiety and Depression Scale, and adverse events. Repeated-measures mixed-effects models were used to analyze data. Poisson regression models were used to analyze adverse event incidence rate ratio. Results: A total of 193 participants were allocated to UC + BrEX ( n  = 94) or UC ( n  = 99). UC + BrEX was superior in the primary outcome (adjusted mean change difference, 0.35; 95% confidence interval [CI], 0.07 to 0.62). Superiority in Mini-AQLQ was sustained at 12 months (0.38; 95% CI, 0.12 to 0.65). A minor improvement in Hospital Anxiety and Depression Scale depression score at 6 months favoring UC + BrEX (-0.90; 95% CI, -1.67 to -0.14) was observed. Asthma-related adverse events occurred similarly in UC + BrEX and UC participants: 14.9% versus 18.1% ( P  = 0.38). Conclusions: BrEX as add-on to usual care improve asthma-related QoL in incompletely controlled asthma regardless of severity and with no evidence of harm. Clinical trial registered with www.clinicaltrials.gov (NCT03127059).

Background: Inhaled corticosteroids (ICS) are frequently prescribed outside guidelines to patients with chronic obstructive pulmonary disease (COPD) with mild/moderate airflow limitation and low exacerbation risk. This primary care trial explored the feasibility of identifying patients with mild/moderate COPD taking ICS, and the acceptability of ICS withdrawal., Methods: Open feasibility trial. Outcome measures included prevalence of suitable participants, feasibility of their identification, their willingness-to-accept open randomisation to ICS withdrawal or continuation over 6 months follow-up., Results: 392 (13%) of 2967 patients with COPD from 20 practices (209 618 population) identified as eligible for ICS withdrawal by electronic search algorithm. After individual patient record review, 243 (62%) were excluded because of: severe airflow limitation (65, 17%); one or more severe or two or more moderate COPD exacerbations in the previous year (86, 22%); asthma (15, 4%); and severe comorbidities (77, 20%). After exclusion, 149 patients with COPD were invited to participate and 61 agreed to randomisation. At clinical assessment, 10 patients exhibited undocumented airflow reversibility (forced expiratory volume in 1 s (FEV 1 ) reversibility >12% and >200 mL); 2 had suffered two or more undocumented, moderate exacerbations in the previous year; 7 had severe airflow limitation; and 2 had normal spirometry. Finally, 40 were randomised. One patient died and one was lost to follow-up. 18 (45%) of the 38 (10 withdrawal and 8 usual care) exhibited previously undocumented FEV 1 variability suggestive of asthma, supported in the withdrawal group by significant associations with elevated fractional exhaled nitric oxide (p=0.04), elevated symptom score (p=0.04), poorer quality of life (p=0.04) and atopic status (p=0.01)., Conclusions: Identifying primary care patients with mild/moderate COPD suitable for ICS withdrawal is feasible but requires real-time verification because of unreliable recording of exacerbations and lung function. Suitable patients accepted randomisation to ICS withdrawal or continuation for the purposes of future studies. Follow-up compliance was high. Nearly 50% of participants with a diagnosis of mild/moderate COPD demonstrated previously undocumented FEV 1 variability during follow-up, mandating monitoring for at least 6 months following withdrawal to exclude undiagnosed asthma., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Background: The benefit of fractional exhaled nitric oxide (FeNO) in guiding asthma treatment is uncertain. We evaluated the efficacy of adding FeNO to symptom-guided treatment in children with asthma versus only symptom-guided treatment., Methods: RAACENO was a multicentre, parallel, randomised, controlled, phase 3 trial done in 35 secondary care centres and 17 primary care recruitment sites (only seven primary care sites managed to recruit patients) in the UK. Patients with a confirmed asthma diagnosis, aged 6-15 years, prescribed inhaled corticosteroids, and who received a course of oral corticosteroids for at least one asthma exacerbation during the 12 months before recruitment were included. Participants were randomly assigned to either FeNO plus symptom-guided treatment (intervention) or symptom-guided treatment alone (standard care) using a 24 h in-house, web-based randomisation system. Participants and the clinical and research teams were not masked to the group allocation. A web-based algorithm gave treatment recommendations based on the Asthma Control Test (ACT) or Childhood ACT (CACT) score; current asthma treatment; adherence to study treatment in the past 3 months; and use of FeNO (in the intervention group). Follow-up occurred at 3-month intervals for 12 months. The primary outcome was any asthma exacerbation treated with oral corticosteroids in the 12 months after randomisation, assessed in the intention-to-treat population. This study is registered with the International Standard Randomised Controlled Trial Registry, ISRCTN67875351., Findings: Between June 22, 2017, and Aug 8, 2019, 535 children were assessed for eligibility, 20 were ineligible and six were excluded post-randomisation. 509 children were recruited and at baseline, the mean age of participants was 10·1 years (SD 2·6), and 308 (60·5%) were male. The median FeNO was 21 ppb (IQR 10-48), mean predicted FEV 1 was 89·6% (SD 18·0), and median daily dose of inhaled corticosteroids was 400 μg budesonide equivalent (IQR 400-1000). Asthma was partly or fully controlled in 256 (50·3%) of 509 participants. The primary outcome, which was available for 506 (99%) of 509 participants, occurred in 123 (48·2%) of 255 participants in the intervention group and 129 (51·4%) of 251 in the standard care group, the intention-to-treat adjusted odds ratio (OR) was 0·88 (95% CI 0·61 to 1·27; p=0·49). The adjusted difference in the percentage of participants who received the intervention in whom the primary outcome occurred compared with those who received standard care was -3·1% (-11·9% to 5·6%). In 377 (21·3%) of 1771 assessments, the algorithm recommendation was not followed. Adverse events were reported by 27 (5·3%) of 509 participants (15 in the standard care group and 12 in the intervention group). The most common adverse event was itch after skin prick testing (reported by eight participants in each group)., Interpretation: We found that the addition of FeNO to symptom-guided asthma treatment did not lead to reduced exacerbations among children prone to asthma exacerbation. Asthma symptoms remain the only tool for guiding treatment decisions., Funding: National Institute for Health Research., Competing Interests: Declaration of interests DP 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, FIECON, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma, PeerVoice, Phadia, Spirosure, Strategic North, Synapse Research Management Partners, Talos Health Solutions, Theravance, and WebMD Global; grants and unrestricted funding for investigator-initiated studies (conducted by the Observational and Pragmatic Research Institute) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance, and the UK National Health Service; payment for lectures or speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, and Sanofi Genzyme; payment for travel, accommodation, and meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, and Thermo Fisher Scientific; stock and stock options from AKL Research and Development, which produces phytopharmaceuticals; owns 74% of the social enterprise of Optimum Patient Care (Australia and the UK) and 93% of the Observational and Pragmatic Research Institute (Singapore); has 5% shareholding in Timestamp, which develops adherence monitoring technology; and is a peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Current methods to assess asthma and guide inhaled corticosteroid (ICS) dose titration mainly centre on patient-reported symptoms and lung function assessments. However, these methods correlate only weakly with airway inflammation making them unreliable predictors of future exacerbations and ICS requirement. Fractional Exhaled Nitric Oxide (FeNO) is a simple non-invasive objective measure of airways inflammation used predominantly in specialist clinics. Previous qualitative studies have mainly focused on the acceptability of FeNO in secondary care and there is limited insight to support clinicians and patients using FeNO in primary care asthma reviews. This study aimed to explore adult patient with asthma and primary care health care professional (HCP) views on introducing FeNO as part of routine asthma reviews. Twenty-three health care professionals and 22 patients were interviewed over the phone or online. Both groups reported that current asthma reviews are often seen as tick-box exercises and that introducing the FeNO test would make reviews more tailored to the individual patient, rather than relying on subjective patient reports of asthma control. Adults with asthma also highlighted support more open communication and their understanding of asthma, as they desired to feel more engaged in decisions and conversations about their asthma. HCPs reported valuing patient education and empowerment over a paternalistic approach, when time and resources allow. They also recognised FeNO to provide an objective measure of inflammation that could support them in the education and empowerment of patients. FeNO was seen by both groups as a potentially valuable addition to current asthma reviews mainly led by nurses, both for increasing their understanding of current risk of exacerbation and also to provide more tailored and personalised asthma management to patients. Our findings highlighted the need for open and clear communication about how to interpret FeNO results., (© 2022. Crown.)

Asthma outcomes remain suboptimal, despite effective pharmacotherapy. Psychological dysfunction (such as anxiety) is common, and associated with poorer outcomes. We evaluated a digital mindfulness programme as an intervention to improve asthma-related quality of life for primary care patients, in a prospectively registered randomized-controlled feasibility study. We offered 'Headspace', a widely-used digital mindfulness intervention, to adults with asthma through 16 UK GP practices. Participants were randomized on a 2:1 basis to the mindfulness intervention, or waitlist control. Participants completed questionnaires (including asthma symptom control, asthma-related quality of life, anxiety, depression) at baseline, 6-week and 3-month follow-up. 116 participants completed primary outcomes at 3-month follow-up: intervention 73 (79%), control 43 (84%). Compared to baseline, the intervention group but not the control group reported significantly improved asthma-related quality of life, with a between-group difference favoring the intervention group that was not significant (Mean difference = 0.15, 95%CI - 0.13 to 0.42). Intervention use varied (ranging from 0 to 192 times) but was generally high. Digital mindfulness interventions are feasible and acceptable adjunct treatments for mild and moderate asthma to target quality of life. Further research should adapt 'generic' mindfulness-based stress-reduction to maximize effectiveness for asthma, and validate our findings in a fully-powered randomized controlled trial.Trial registration Prospectively registered: ISRCTN52212323., (© 2021. The Author(s).)

Background: Diagnosing asthma in children represents an important clinical challenge. There is no single gold-standard test to confirm the diagnosis. Consequently, over- and under-diagnosis of asthma is frequent in children., Methods: A task force supported by the European Respiratory Society has developed these evidence-based clinical practice guidelines for the diagnosis of asthma in children aged 5-16 years using nine Population, Intervention, Comparator and Outcome (PICO) questions. The task force conducted systematic literature searches for all PICO questions and screened the outputs from these, including relevant full-text articles. All task force members approved the final decision for inclusion of research papers. The task force assessed the quality of the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach., Results: The task force then developed a diagnostic algorithm based on the critical appraisal of the PICO questions, preferences expressed by lay members and test availability. Proposed cut-offs were determined based on the best available evidence. The task force formulated recommendations using the GRADE Evidence to Decision framework., Conclusion: Based on the critical appraisal of the evidence and the Evidence to Decision framework, the task force recommends spirometry, bronchodilator reversibility testing and exhaled nitric oxide fraction as first-line diagnostic tests in children under investigation for asthma. The task force recommends against diagnosing asthma in children based on clinical history alone or following a single abnormal objective test. Finally, this guideline also proposes a set of research priorities to improve asthma diagnosis in children in the future., Competing Interests: Conflict of interest: E.A. Gaillard reports consultancy work for Boehringer Ingelheim with money paid to the University of Leicester; investigator led research grants from Circassia, Gilead and Chiesi Ltd; research collaboration with Medimmune. Conflict of interest: C.E. Kuehni has nothing to disclose. Conflict of interest: S. Turner has nothing to disclose. Conflict of interest: M. Goutaki has nothing to disclose. Conflict of interest: K.A. Holden has nothing to disclose. Conflict of interest: C.C.M. de Jong has nothing to disclose. Conflict of interest: C. Lex reports other (lecture fee paid to institution) from Novartis, outside the submitted work. Conflict of interest: D.K.H. Lo has nothing to disclose. Conflict of interest: J.S. Lucas reports grants and non-financial support (provision of equipment) from Circassia, outside the submitted work. Conflict of interest: F. Midulla has nothing to disclose. Conflict of interest: R. Mozun has nothing to disclose. Conflict of interest: G. Piacentini has nothing to disclose. Conflict of interest: D. Rigau acts as ERS methodologist. Conflict of interest: B. Rottier has nothing to disclose. Conflict of interest: M. Thomas reports personal fees from GSK, Boehringer Ingelheim and Chiesi, outside the submitted work. Conflict of interest: T. Tonia acts as ERS Methodologist. Conflict of interest: J. Usemann reports personal fees from Vertex, outside the submitted work. Conflict of interest: O. Yilmaz reports non-financial support for meeting attendance from Abdi Ibrahim, other (lecture fees) from Novartis, outside the submitted work. Conflict of interest: A. Zacharasiewicz has nothing to disclose. Conflict of interest: A. Moeller has nothing to disclose., (Copyright ©The authors 2021. For reproduction rights and permissions contact permissions@ersnet.org.)

Asthma and chronic obstructive pulmonary disease (COPD) are two prevalent chronic airways diseases. Both are complex and heterogeneous. Traditionally, clinical guidelines have advocated a stepwise approach to pharmacotherapy of asthma and COPD, but there is increasing realization that both require a more personalized and precise management approach. To this end, a management strategy based on the so-called Treatable Traits has been proposed. Emerging evidence suggests that this model improves relevant outcomes in patients with chronic airway diseases but further research is needed to guide implementation. This review discusses the challenges, opportunities, and hurdles that its implementation will have to face., (Copyright © 2021. Published by Elsevier Ltd.)

Asthma differs from many other chronic conditions in that most key management decisions are made in non-specialist settings, such as general practitioner surgeries and accident and emergency departments. Diagnosis in primary care relies on recognition of a characteristic pattern of symptoms and the occurrence of asthma attacks, sometimes supplemented by basic lung function tests. Ongoing management is guided by the assessment of symptoms and simple lung function measures of airflow obstruction, with little attempt made to personalise management. This approach is flawed because the inadequate specificity of symptoms, as well as the low sensitivity of variable airflow obstruction, means that a diagnosis of asthma is often difficult to exclude with confidence. Moreover, even if diagnosed correctly, dissociation between inflammation, airflow obstruction, and symptoms means that a generalised stepwise approach to managing asthma on the basis of symptoms is unlikely to be successful in a substantial proportion of patients. As a result, effective treatments are used inefficiently, and outcomes are often worse than they could be. Rather than use of either a population-based or personalised approach for the diagnosis and management of asthma, we recommend a new combined approach, in which treatment decisions are driven by objective assessment of key treatable mechanistic traits., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Asthma exacerbations are major contributors to asthma morbidity and mortality. They are usually managed with bronchodilators and oral corticosteroids (OCS), but clinical trial evidence suggests that antibiotics could be beneficial. We aimed to assess whether treatment of asthma exacerbations with antibiotics in addition to OCS improved outcomes in larger, more representative routine-care populations., Method: A retrospective comparative effectiveness study into managing asthma exacerbations with OCS alone versus OCS plus antibiotics was conducted using the Optimum Patient Care Research Database. The dataset included 28 637 patients; following propensity score matching 20 024 adults and 4184 children were analysed., Results: Antibiotics in addition to OCS were prescribed for the treatment of asthma exacerbations in 45% of adults and 32% of children. Compared to OCS alone, OCS plus antibiotics was associated with reduced risk of having an asthma/wheeze consultation in the following 2 weeks (children hazard ratio (HR) 0.84 (95% CI 0.73-0.96), p=0.012; adults HR 0.86 (95% CI 0.81-0.91), p<0.001), but an increase in risk of a further OCS prescription for a new/ongoing exacerbation within 6 weeks in adults (HR 1.11 (95% CI 1.01-1.21), p=0.030), but not children. Penicillins, but not macrolides, were associated with a reduction in the odds of a subsequent asthma/wheeze consultation compared to OCS alone, in both adults and children., Conclusion: Antibiotics were frequently prescribed in relation to asthma exacerbations, contrary to guideline recommendations. Overall, the routine addition of antibiotics to OCS in the management of asthma exacerbations appeared to confer little clinical benefit, especially when considering the risks of antibiotic overuse., Competing Interests: Conflict of interest: C.S. Murray reports personal fees from AstraZeneca, Thermo Fisher, Boehringer Ingelheim, GSK and Novartis, outside the submitted work. Conflict of interest: S.J. Lucas has nothing to disclose. Conflict of interest: J. Blakey reports personal fees and non-financial support from AstraZeneca and Boehringer Ingelheim, personal fees from TEVA, non-financial support from GSK, grants from Novartis, outside the submitted work. Conflict of interest: A. Kaplan reports personal fees from AstraZeneca, Behring, Boehringer Ingelheim, GSK, Novartis, Reva, Covis, Merck, Trudell, Pfizer, Purdue, NovoNordisk and Griffols, outside the submitted work. Conflict of interest: A. Papi reports grants, personal fees for advisory board work, lectures and consultancy, and non-financial support (travel expenses reimbursement) from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici and TEVA, personal fees for advisory board work, lectures and consultancy, and non-financial support (travel expenses reimbursement) from Mundipharma, Zambon, Novartis and Sanofi/Regeneron, grants, personal fees for lectures and non-financial support (travel expenses reimbursement) from Menarini, personal fees for advisory board work and non-financial support (travel expenses reimbursement) from Roche, grants from Fondazione Maugeri and Chiesi, personal fees for consultancy from Edmondpharma, outside the submitted work. Conflict of interest: J. Paton has nothing to disclose. Conflict of interest: W. Phipatanakul reports grants and personal fees for consultancy from Genentech/Novartis and Regeneron/Sanofi, other (reagent support) from Thermo Fisher, other (clinical trial/medication support) from GSK and Kaleo, other (clinical trial support) from Lincoln Diagnostics and Monaghen, during the conduct of the study. Conflict of interest: D. Price reports grants and personal fees for advisory board work, consultancy and lectures from AstraZeneca, Chiesi, Boehringer Ingelheim, Teva Pharmaceuticals, Novartis, Mylan and Mundipharma, grants and personal fees for advisory board work from Circassia, grants and personal fees for advisory board work and lectures from Regeneron Pharmaceuticals and Sanofi Genzyme, grants and personal fees for consultancy from Pfizer and Theravance, grants from Respiratory Effectiveness Group and UK National Health Service, personal fees for advisory board work and consultancy from Amgen, personal fees for advisory board work, consultancy and lectures from GSK, personal fees for lectures from Cipla and Kyorin, personal fees for advisory board work and travel to meetings from Thermofisher, outside the submitted work; and 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 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. Conflict of interest: O.H. Teoh has nothing to disclose. Conflict of interest: M. Thomas reports personal fees from GSK, Novartis and Boehringer Ingelheim, outside the submitted work. Conflict of interest: S. Turner has nothing to disclose. Conflict of interest: N.G. Papadopoulos reports personal fees for advisory board work and lectures from Novartis, Nutricia, HAL, Menarini/Faes Farma and Mylan/Meda, personal fees lectures from Sanofi, Biomay, MSD, Asit Biotech and Boehringer Ingelheim, personal fees for advisory board work from AstraZeneca and GSK, grants from Gerolymatos International SA and Capricare, outside the submitted work., (Copyright ©ERS 2021.)

This study aimed to explore user engagement with 'My Breathing Matters', a digital self-management intervention for asthma, and identify factors that may influence engagement. In a mixed methods design, adults with asthma allocated to the intervention arm of a feasibility trial (n = 44) participated in semi-structured interviews (n = 18) and a satisfaction questionnaire (n = 36) to explore their views and experiences of the intervention. Usage data highlighted that key intervention content was delivered to most users. The majority of questionnaire respondents (78%; n = 28) reported they would recommend the intervention to friends and family. Interviewees expressed positive views of the intervention and experienced several benefits, mainly improved asthma control, medication use, and breathing technique. Factors that may influence user engagement were identified, including perceptions of asthma control, current self-management practices, and appeal of the target behaviours and behaviour change techniques. Findings suggested My Breathing Matters was acceptable and engaging to participants, and it was used as intended.

Asthma imposes a substantial burden on individuals and societies. Patients with asthma need high-quality primary care management; however, evidence suggests the quality of this care can be highly variable. Here we identify and report factors contributing to high-quality management. Twelve primary care global asthma experts, representing nine countries, identified key factors. A literature review (past 10 years) was performed to validate or refute the expert viewpoint. Key driving factors identified were: policy, clinical guidelines, rewards for performance, practice organisation and workforce. Further analysis established the relevant factor components. Review evidence supported the validity of each driver; however, impact on patient outcomes was uncertain. Single interventions (e.g. healthcare practitioner education) showed little effect; interventions driven by national policy (e.g. incentive schemes and teamworking) were more effective. The panel's opinion, supported by literature review, concluded that multiple primary care interventions offer greater benefit than any single intervention in asthma management.

Background: High exhaled nitric oxide fraction ( F ) levels are associated with greater risk of asthma exacerbation. However, it is not clear how ENO can be used to guide safe reductions in inhaled corticosteroid (ICS) doses in asthma patients. This study assesses the ability of F ENO can be used to guide safe reductions in inhaled corticosteroid (ICS) doses in asthma patients. This study assesses the ability of F ENO to guide ICS reductions., Methods: Systematic searching of electronic databases identified prospective observational studies and randomised controlled trials which recruited participants with mild-to-moderate asthma aged ≥12 years and measured F ENO before reducing ICS. We performed multilevel mixed-effects logistic regression in relation to acute exacerbations and estimated each participant's exacerbation risk using our logistic regression model., Results: We included data from seven out of eight eligible studies, representing 384 participants. ICS doses were halved in four studies and withdrawn in three studies. A baseline F ENO measurement of ≥50 ppb was associated with increased risk of exacerbations (crude OR 3.14, 95% CI 1.41-7.00, p=0.005; adjusted OR 3.08, 95% CI 1.36-6.98, p=0.007) and corresponded to an estimated exacerbation risk cut-off of 15%. Reducing ICS when estimated exacerbation risk was <15% versus <10% would result in fewer patients remaining on the same ICS dose (40 (10.4%) out of 384 versus 141 (36.7%) out of 384), but similar proportions of patients avoiding exacerbations (222 (91.4%) out of 243, 95% CI 87.1-94.6% versus 311 (90.4%) out of 344, 95% CI 86.8-93.3%)., Conclusion: In patients with mild-to-moderate asthma, gradual ICS reduction when F ENO is <50 ppb may help decrease ICS use without increasing exacerbations. Future research should aim to validate these findings in larger populations., Competing Interests: Conflict of interest: K. Wang reports grants from National Institute for Health Research, during the conduct of the study. Conflict of interest: J.Y. Verbakel has nothing to disclose. Conflict of interest: J. Oke has nothing to disclose. Conflict of interest: A. Fleming-Nouri has nothing to disclose. Conflict of interest: J. Brewin has nothing to disclose. Conflict of interest: N. Roberts has nothing to disclose. Conflict of interest: N. Harada reports personal fees from AstraZeneca, outside the submitted work. In addition, N. Harada has a patent Japanese Patent Application 2018-097070 pending. Conflict of interest: R. Atsuta has nothing to disclose. Conflict of interest: K. Takahashi reports grants and personal fees from Chugai Pharmaceutical Co., Ltd, grants and personal fees from Nippon Boehringer Ingelheim Co., Ltd, grants and personal fees from MSD K.K., grants from GlaxoSmithKline Consumer Healthcare Japan K.K., grants from Nippon Shinyaku Co., Ltd, grants from Tsumura & Co., grants and personal fees from Pfizer Inc., grants and personal fees from AstraZeneca K.K., grants and personal fees from Taiho Pharmaceutical Co., Ltd, grants from Astellas Pharma Inc., grants and personal fees from Kyorin Pharmaceutical Co., Ltd, grants from Kyowa Hakko Kirin Co., Ltd, grants and personal fees from Teijin Pharma Limited, grants from Mochida Pharmaceutical Co., Ltd, grants from Toyama Chemical Co., Ltd, grants from Sanofi K.K., grants and personal fees from Ono Pharmaceutical Co., Ltd, grants and personal fees from Nobelpharma Co., Ltd, grants and personal fees from Novartis Pharma K.K., grants from Shionogi & Co., Ltd, grants and personal fees from Eli Lilly Japan K.K., grants from Nipro Corporation, grants from Torii Pharmaceutical Co., Ltd, grants from MiZ Company Limited, personal fees from Sumitomo Dainippon Pharma Co., Ltd, personal fees from Bristol-Myers K.K., personal fees from Meiji Seika Pharma Co., Ltd, personal fees from Otsuka Pharmaceutical Co., Ltd, personal fees from Parexel International Corporation, personal fees from Eisai Co., Ltd, personal fees from Mitsubishi Tanabe Pharma, outside the submitted work. Conflict of interest: K. Mori has nothing to disclose. Conflict of interest: T. Fujisawa has nothing to disclose. Conflict of interest: T. Shirai has nothing to disclose. Conflict of interest: T. Kawayama has nothing to disclose. Conflict of interest: H. Inoue reports grants from Astellas, AstraZeneca, Boehringer-Ingelheim, Chugai Pharm, GlaxoSmithKline, Pfizer, Merck Sharp & Dohme, Novartis, Teijin-Pharma, personal fees from Astellas, AstraZeneca, Boehringer-Ingelheim, Chugai Pharm, GlaxoSmithKline, Kyorin, Merck Sharp & Dohme, Meiji Seika Pharma, Novartis, Otsuka, Pfizer, Taiho, outside the submitted work. Conflict of interest: S. Lazarus reports grants from NIH/NHLBI, during the conduct of the study; grants from NIH/NHLBI, grants from American Lung Association – Airway Clinical Research Centers Network (ALA-ACRC), outside the submitted work. Conflict of interest: S. Szefler reports other from Boehringer-Ingelheim, other from Genentech, other from GlaxoSmithKline, other from AstraZeneca, other from Daiichi Sankyo, grants from GlaxoSmithKline, other from Propeller Health, other from Sanofi, other from Regeneron, outside the submitted work. Conflict of interest: F. Martinez reports grants from NIH/NHLBI, grants from NIH/NIEHS, grants from NIH/NIAID, grants from NIH/Office of Director, grants from Johnson & Johnson, personal fees from Copeval, personal fees from Commense Inc, outside the submitted work. Conflict of interest: D. Shaw reports personal fees from AstraZeneca, GSK, TEVA and Novartis, outside the submitted work. Conflict of interest: I.D. Pavord reports personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Aerocrine, personal fees from Almirall, personal fees from Novartis, personal fees from GlaxoSmithKline, personal fees from Genentech, personal fees from Regeneron, speakers’ fees from Teva, speakers’ fees from Chiesi, advisory board fees from Sanofi, advisory board fees from Circassia, advisory board fees from Knopp, grants from NIHR, outside the submitted work. Conflict of interest: M. Thomas reports personal fees from GSK, personal fees from Novartis, personal fees from Boehringer Ingelheim, outside the submitted work; and recent membership of the BTS SIGN Asthma guideline steering group and the NICE Asthma Diagnosis and Monitoring guideline development group., (Copyright ©ERS 2020.)

Introduction and Aim: Uncontrolled asthma is a global health challenge with substantial impact on quality of life (QoL) and overall healthcare costs. Unrecognised and/or unmanaged comorbidities often contribute to presence of uncontrolled asthma. Abnormalities in breathing pattern are termed dysfunctional breathing and are not only common in asthma but also lead to asthma-like symptoms and reduced QoL, and, in keeping with this, improvement with breathing normalisation. Evidence-based guidelines recommend breathing retraining interventions as an adjuvant treatment in uncontrolled asthma. Physiotherapy-based breathing pattern modification interventions incorporating relaxation have been shown to improve asthma-related QoL in primary care patients with impaired asthma control. Despite anecdotal reports, effectiveness of breathing retraining in patients referred to secondary care with incomplete asthma control has not been formally assessed in a randomised controlled trial (RCT). We aim to investigate the effect of breathing exercises on asthma-related QoL in patients with incomplete asthma control despite specialist care., Methods and Analysis: This two-armed assessor-blinded multicentre RCT will investigate the effect of physiotherapist-delivered breathing retraining on asthma QoL questionnaire (MiniAQLQ) in addition to usual specialist care, recruiting from seven outpatient departments and one specialised clinic representing all regions of Denmark during 2017-2019. We will include 190 consenting adults with incomplete asthma control, defined as Asthma Control Questionnaire 6-item score ≥0.8. Participants will randomly be allocated to either breathing exercise programme in addition to usual care (BrEX +UC) or UC alone. BrEX compiles three physiotherapy sessions and encouragement to perform home exercise daily. Both groups continue usual secondary care management. Primary outcome is between-group difference in MiniAQLQ at 6 months. Secondary outcomes include patient-reported outcome measures, spirometry and accelerometer., Ethics and Dissemination: Ethics Committee, Region Zealand (SJ-552) and Danish Data Protection Agency (REG-55-2016) approved the trial. Results will be reported in peer-reviewed scientific journals., Trial Registration Number: NCT03127059; Pre-results., Competing Interests: Competing interests: STS is an associate editor of the Journal of Orthopaedic & Sports Physical Therapy, has received grants from The Lundbeck Foundation, personal fees from Munksgaard, all of which are outside the submitted work. He is co-founder of GLA:D®, a not-for profit initiative hosted at University of Southern Denmark aimed at implementing clinical guidelines for osteoarthritis in clinical practice., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess the feasibility of a randomised controlled trial (RCT) and acceptability of an asthma self-management digital intervention to improve asthma-specific quality of life in comparison with usual care., Design and Setting: A two-arm feasibility RCT conducted across seven general practices in Wessex, UK., Participants: Primary care patients with asthma aged 18 years and over, with impaired asthma-specific quality of life and access to the internet., Interventions: 'My Breathing Matters' (MBM) is a digital asthma self-management intervention designed using theory, evidence and person-based approaches to provide tailored support for both pharmacological and non-pharmacological management of asthma symptoms., Outcomes: The primary outcome was the feasibility of the trial design, including recruitment, adherence and retention at follow-up (3 and 12 months). Secondary outcomes were the feasibility and effect sizes of specific trial measures including asthma-specific quality of life and asthma control., Results: Primary outcomes: 88 patients were recruited (target 80). At 3-month follow-up, two patients withdrew and six did not complete outcome measures. At 12 months, two withdrew and four did not complete outcome measures. 36/44 patients in the intervention group engaged with MBM (median of 4 logins, range 0-25, IQR 8). Consistent trends were observed to improvements in asthma-related patient-reported outcome measures., Conclusions: This study demonstrated the feasibility and acceptability of a definitive RCT that is required to determine the clinical and cost-effectiveness of a digital asthma self-management intervention., Trial Registration Number: ISRCTN15698435., Competing Interests: Competing interests: Neither MT nor any member of his close family has any shares in pharmaceutical companies. In the last 3 years, he has received speaker’s honoraria for speaking at sponsored meetings or satellite symposia at conferences from the following companies marketing respiratory and allergy products: GSK, Novartis. He has received honoraria for attending advisory panels with; Boehringer Inglehiem, GSK, Novartis. He is a recent a member of the BTS SIGN Asthma guideline steering group and the NICE Asthma Diagnosis and Monitoring guideline development group. BA, KG, JR, BS, LY, FM and AB have no competing interests., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Asthma is a common non-communicable disease, often characterized by activity limitation, negative effects on social life and relationships, problems with finding and keeping employment, and poor quality of life. The objective of the present study was to conduct a systematic review of the literature investigating the potential factors impacting quality of life (QoL) in asthma. Electronic searches were carried out on: MEDLINE, EMBASE, PsycINFO, the Cochrane Library, and Web of Science (initial search April 2017 and updated in January 2019). All primary research studies including asthma, psychological or physical health factors, and quality of life were included. Narrative synthesis was used to develop themes among findings in included studies in an attempt to identify variables impacting QoL in asthma. The search retrieved 43 eligible studies that were grouped in three themes: psychological factors (including anxiety and depression, other mental health conditions, illness representations, and emotion regulation), physical health factors (including BMI and chronic physical conditions), and multifactorial aspects, including the interplay of health and psychological factors and asthma. These were found to have a substantial impact on QoL in asthma, both directly and indirectly, by affecting self-management, activity levels and other outcomes. Findings suggest a complex and negative effect of health and psychological factors on QoL in asthma. The experience of living with asthma is multifaceted, and future research and intervention development studies should take this into account, as well as the variety of variables interacting and affecting the person.

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and or have no relevant interests to declare.

Background: Asthma exacerbations affect the quality of life of patients with asthma and have a major effect on the overall costs of asthma care. An asthma self-management plan that advises the temporary quadrupling of inhaled corticosteroid dose may prevent asthma exacerbations, but this needs to be confirmed before being adopted widely., Objectives: To compare the clinical effectiveness and cost-effectiveness of an asthma self-management plan that advises patients to temporarily quadruple the dose of inhaled corticosteroid when asthma control starts to deteriorate with a standard self-management plan., Design: A multicentre, parallel-group, pragmatic randomised trial, with follow-up for 12 months., Setting: Primary and secondary care across 207 sites in the UK., Participants: Asthma patients aged ≥ 16 years treated with an inhaled corticosteroid who had experienced at least one exacerbation in the previous 12 months., Interventions: Participants were randomised (1 : 1) to a usual-care self-management plan or to a modified self-management plan that advised a temporary quadrupling of the inhaled corticosteroid at the point of asthma deterioration, both of which were actively implemented and supported by local research staff., Primary Outcome: The primary outcome of 'time to first asthma exacerbation' was defined as the need for systemic corticosteroids (for at least 3 consecutive days) and/or unscheduled health-care consultations for asthma (i.e. reaching zone 3 or 4 of the Asthma UK self-management plan)., Results: A total of 1922 participants were randomised: the primary analysis included 938 participants (97%) in the usual-care group and 933 participants (97%) in the modified self-management group. The number of participants having at least one exacerbation of asthma in the year after randomisation was 484 (51.6%) in the usual-care group and 420 (45.0%) in the modified self-management group [adjusted hazard ratio 0.81, 95% confidence interval (CI) 0.71 to 0.92; p  = 0.002]. There were fewer serious adverse events reported in the modified self-management group than in the usual-care group (11 vs. 32, respectively). Eight and six events of pneumonia, lower respiratory tract infections or influenza were reported in the usual-care group and the modified self-management group, respectively. Health-care-related costs were lower in the modified self-management group. The modified self-management group was £24 (bootstrapped 95% CI -£122 to £71) less costly than usual care, with a greater quality-adjusted life-year gain of 0.02 (bootstrapped 95% CI -0.005 to 0.04). Therefore, the modified self-management group was 'dominant', with a 94-95% probability of being cost-effective at the £20,000-30,000 threshold., Limitations: As the Fourfold Asthma STudy (FAST) was an open-label pragmatic trial, the possibility of treatment bias that may have affected the participants in the modified self-management group cannot be ruled out. Poorer than expected completion of participant diary cards, particularly within the usual-care self-management group, could have led to a null bias, underestimating the true effect of the intervention., Conclusions: An asthma self-management plan that advises patients to temporarily quadruple their dose of inhaled corticosteroid at the point of asthma symptoms worsening does reduce clinically important asthma exacerbations. In addition, the plan is cost-effective compared with the usual-care self-management plan., Future Work: To effectively implement asthma self-management plans that advise a temporary quadrupling of inhaled steroid at asthma deterioration into routine practice., Trial Registration: Current Controlled Trials ISRCTN15441965., Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 70. See the NIHR Journals Library website for further project information., Competing Interests: David Price reports board membership fees paid to the Observational and Pragmatic Research Institute from Aerocrine AB, Amgen Inc., AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Chiesi Farmaceutici S.p.A., Mylan N.V., Mundipharma GmbH, Napp Pharmaceutical Group Ltd, Novartis Pharmaceutical Company and Teva Pharmaceutical Industries Ltd; consultancy agreement fees paid to the Observational and Pragmatic Research Institute from Almirall S.A., Amgen Inc., AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Chiesi Farmaceutici S.p.A., GlaxoSmithKline plc, Mylan N.V., Mundipharma GmbH, Napp Pharmaceutical Group Ltd, Novartis Pharmaceutical Company, Pfizer Inc., Teva Pharmaceutical Industries and Theravance Biopharma; grants from Aerocrine AB, AKL Research and Development Ltd, AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, the British Lung Foundation, Chiesi Farmaceutici S.p.A., Mylan N.V., Mundipharma GmbH, Napp Pharmaceutical Group Ltd, Novartis Pharmaceutical Company, Pfizer Inc., the Respiratory Effectiveness Group, Teva Pharmaceutical Industries, Theravance Biopharma, the UK National Health Service and Zentiva N.V.; lecture/speaking engagement fees paid to the Observational and Pragmatic Research Institute from Almirall S.A., AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Chiesi Farmaceutici S.p.A., Cipla Ltd, GlaxoSmithKline plc, KYORIN Pharmaceutical Co., Ltd, Mylan N.V., Merck & Company, Inc., Mundipharma GmbH, Novartis Pharmaceutical Company, Pfizer Inc., Skyepharma and Teva Pharmaceutical Industries; manuscript preparation fees paid to the Observational and Pragmatic Research Institute from Mundipharma GmbH and Teva Pharmaceutical Industries; travel expenses fees paid to the Observational and Pragmatic Research Institute from Aerocrine AB, AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Mundipharma GmbH, Napp Pharmaceutical Group Ltd, Novartis Pharmaceutical Company and Teva Pharmaceutical Industries; funding for patient enrolment or completion of research fees paid to the Observational and Pragmatic Research Institute from Chiesi Farmaceutici S.p.A., Novartis Pharmaceutical Company, Teva Pharmaceutical Industries and Zentiva N.V.; and payment for developing educational materials fees paid to the Observational and Pragmatic Research Institute from Mundipharma GmbH and Novartis Pharmaceutical Company. David Price is a peer reviewer for grant committees for the Efficacy and Mechanism Evaluation and Health Technology Assessment (HTA) programmes. He has stock/stock options from AKL Research and Development Ltd that produces phytopharmaceuticals, and owns 74% of the social enterprise Optimum Patient Care Ltd (in Australia, Singapore and the UK) and 74% of the Observational and Pragmatic Research Institute Pte Ltd (Singapore). Ian Pavord reports grants from GlaxoSmithKline during the conduct of the study; has received speaker’s honoraria from AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Aerocrine AB, Almirall S.A., Novartis Pharmaceutical Company and GlaxoSmithKline; has received honoraria for attending advisory board panels from Almirall S.A., AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Dey Pharma, L.P., GlaxoSmithKline, Merck Sharp & Dohme, Schering-Plough, Novartis Pharmaceutical Company, Napp Pharmaceutical Group Ltd and RespiVert Ltd; and has received sponsorship for attending international scientific meetings from AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, GlaxoSmithKline and Napp Pharmaceutical Group Ltd. Mike Thomas received speaker’s honoraria for speaking at sponsored meetings or satellite symposia at conferences from Aerocrine AB, GlaxoSmithKline and Novartis Pharmaceutical Company. He has received honoraria for attending advisory panels with Aerocrine AB, Boehringer Ingelheim, GlaxoSmithKline, Merck Sharp & Dohme, Novartis Pharmaceutical Company and Pfizer Inc. during the conduct of the study. He reports grants from the National Institute for Health Research during the conduct of the study; being a member of the HTA Primary Care Community and Preventative Interventions Panel during the conduct of the study; and personal fees from GlaxoSmithKline, Novartis Pharmaceutical Company, Boehringer Ingelheim and Aerocrine AB outside the submitted work. He is a member of the British Thoracic Society/Scottish Intercollegiate Guidelines Network’s Asthma Guideline Steering Group and the National Institute for Health and Care Excellence’s Asthma Diagnosis and Monitoring Guideline Development Group. Christopher Brightling received payment via his institution of grants and personal fees from AstraZeneca plc/MedImmune, LLC, GlaxoSmithKline plc, F. Hoffmann-La Roche AG/Genentech, Inc., Novartis Pharmaceutical Company, Chiesi Farmaceutici S.p.A., Pfizer Inc., Teva Pharmaceutical Industries, Sanofi S.A./Regeneron Pharmaceuticals, Inc., Glenmark Pharmaceuticals, Mologic Ltd and Vectura Group plc.

Inhaled medications are the cornerstone of treatment and management of asthma and COPD. However, inhaler device errors are common among patients and have been linked with reduced symptom control, an increased risk of exacerbations, and increased healthcare utilisation. These observations have prompted GINA (Global INitiative for Asthma) and GOLD (Global initiative for chronic Obstructive Lung Disease) to recommend regular assessment of inhaler technique in a bid to improve therapeutic outcomes. To better define the relationship between device errors and health outcomes (clinical outcomes, quality of life, and healthcare utilisation) in asthma and COPD, we conducted a systematic review of the literature, with a particular focus on the methods used to assess the relationship between device errors and outcomes. Sixteen studies were identified (12 in patients with asthma, one in patients with COPD, and three in both asthma and COPD) with varying study designs, endpoints, and patient populations. Most of the studies reported that inhalation errors were associated with worse disease outcomes in patients with asthma or COPD. Patients who had a reduction in errors over time had improved outcomes. These findings suggest that time invested by healthcare professionals is vital to improving inhalation technique in asthma and COPD patients to improve health outcomes.

Current understanding of risk factors for asthma attacks in children is based on studies of small but well-characterised populations or pharmaco-epidemiology studies of large but poorly characterised populations. We describe an observational study of factors linked to future asthma attacks in large number of well-characterised children. From two UK primary care databases (Clinical Practice Research Datalink and Optimum Patient Care research Database), a cohort of children was identified with asthma aged 5-12 years and where data were available for ≥2 consecutive years. In the "baseline" year, predictors included treatment step, number of attacks, blood eosinophil count, peak flow and obesity. In the "outcome" year the number of attacks was determined and related to predictors. There were 3776 children, of whom 525 (14%) had ≥1 attack in the outcome year. The odds ratio (OR) for one attack was 3.7 (95% Confidence Interval (CI) 2.9, 4.8) for children with 1 attack in the baseline year and increased to 7.7 (95% CI 5.6, 10.7) for those with ≥2 attacks, relative to no attacks. Higher treatment step, younger age, lower respiratory tract infections, reduced peak flow and eosinophil count >400/μL were also associated with small increases in OR for an asthma attack during the outcome year. In this large population, several factors were associated with a future asthma attack, but a past history of attacks was most strongly associated with future attacks. Interventions aimed at reducing the risk for asthma attacks could use primary care records to identify children at risk for asthma attacks.

The National Review of Asthma Deaths (NRAD) identified high prescribing of short-acting beta 2 -agonists (SABAs) as a key factor in over 40% of deaths. We interviewed asthma experts from both a hospital background (n = 5) and a primary care background (n = 8), and general practitioners delivering asthma care (n = 8), to identify how SABA use is defined and perceived. We identified disparity in how acceptable SABA use is defined, ranging from 0.5 (100 doses/year) to 12 SABA inhalers (2400 doses/year), and complacency in the perception that over-use did not represent a marker for risk of asthma death. Despite current evidence, these findings suggest clinicians of various backgrounds are complacent about excessive SABA use.

Computers are increasingly used to improve prescribing decisions in the management of long-term conditions however the effects on asthma prescribing remain unclear. We aimed to synthesise the evidence for the use of computerised alerts that identify excessive prescribing of short-acting beta 2 -agonists (SABAs) to improve asthma management for people with asthma. MEDLINE, CINAHL, Embase, Cochrane and Scopus databases (1990-2016) were searched for randomised controlled trials using electronic alerts to identify excessive prescribing of SABAs for people with asthma in primary care. Inclusion eligibility, quality appraisal (Cochrane risk of bias tool) and data extraction were performed by two independent reviewers. Findings were synthesised narratively. A total of 2035 articles were screened and four trials were eligible. Three studies had low risk of bias: one reported a positive effect on our primary outcome of interest, excessive SABA prescribing; another reported positive effects on the ratio of inhaled corticosteroid (ICS)-SABA prescribing, and asthma control; a third reported no effect on outcomes of interest. One study at high risk of bias reported a reduction in exacerbations and primary care consultations. There is some evidence that electronic alerts reduce excessive prescribing of SABAs, when delivered as part of a multicomponent intervention in an integrated health care system. However due to the variation in health care systems, intervention design and outcomes measured, further research is required to establish optimal design of alerting and intervening systems.

Background: Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate, would reduce the incidence of severe asthma exacerbations among adults and adolescents with asthma., Methods: We conducted a pragmatic, unblinded, randomized trial involving adults and adolescents with asthma who were receiving inhaled glucocorticoids, with or without add-on therapy, and who had had at least one exacerbation in the previous 12 months. We compared a self-management plan that included an increase in the dose of inhaled glucocorticoids by a factor of 4 (quadrupling group) with the same plan without such an increase (non-quadrupling group), over a period of 12 months. The primary outcome was the time to a first severe asthma exacerbation, defined as treatment with systemic glucocorticoids or an unscheduled health care consultation for asthma., Results: A total of 1922 participants underwent randomization, of whom 1871 were included in the primary analysis. The number of participants who had a severe asthma exacerbation in the year after randomization was 420 (45%) in the quadrupling group as compared with 484 (52%) in the non-quadrupling group, with an adjusted hazard ratio for the time to a first severe exacerbation of 0.81 (95% confidence interval, 0.71 to 0.92; P=0.002). The rate of adverse effects, which were related primarily to local effects of inhaled glucocorticoids, was higher in the quadrupling group than in the non-quadrupling group., Conclusions: In this trial involving adults and adolescents with asthma, a personalized self-management plan that included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate resulted in fewer severe asthma exacerbations than a plan in which the dose was not increased. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN15441965 .).

There is growing awareness amongst healthcare planners, providers and researchers of the need to make better use of routinely collected health data by translating it into actionable information that improves efficiency of healthcare and patient outcomes. There is also increased acceptance of the importance of real world research that recruits patients representative of primary care populations and evaluates interventions realistically delivered by primary care professionals. The UNLOCK Group is an international collaboration of primary care researchers and practitioners from 15 countries. It has coordinated and shared datasets of diagnostic and prognostic variables for COPD and asthma to answer research questions meaningful to professionals working in primary care over a 6-year period. Over this time the UNLOCK Group has undertaken several studies using data from unselected primary care populations from diverse contexts to evaluate the burden of disease, multiple morbidities, treatment and follow-up. However, practical and structural constraints have hampered the UNLOCK Group's ability to translate research ideas into studies. This study explored the constraints, challenges and successes experienced by the UNLOCK Group and its participants' learning as researchers and primary care practitioners collaborating to answer primary care research questions. The study identified lessons for future studies and collaborations that require data sharing across borders. It also explored specific challenges to fostering the exchange of primary care data in comparison to other datasets such as public health, prescribing or hospital data and mechanisms that may be used to overcome these.

Background: Despite effective pharmacotherapy, asthma continues to impair quality of life for most patients. Non-pharmacological approaches, including breathing retraining, are therefore of great interest to patients. However, clinicians rarely advocate breathing retraining and access to this intervention is restricted for most patients due to the limited availability of suitable physiotherapists and poor integration of breathing retraining into standard care. We aimed to assess the effectiveness of a digital self-guided breathing retraining intervention., Methods: In this randomised controlled trial, we recruited patients from 34 general practices in the UK. Eligibility criteria for patients with asthma were broad, comprising a physician diagnosis of asthma, age of 16-70 years, receipt of at least one anti-asthma medication in the previous year, and impaired asthma-related quality of life (Asthma Quality of Life Questionnaire [AQLQ] score of <5·5). We developed a self-guided intervention, which was delivered as a DVD plus a printed booklet (DVDB). Participants were randomly assigned to receive either the DVDB intervention, three face-to-face breathing retraining sessions, or standard care, in a 2:1:2 ratio, for 12 months. Randomisation was achieved using the Southampton Clinical Trials Unit telephone randomisation service by use of random number generators. The primary outcome was the AQLQ score in the intention-to-treat population at 12 months. The trial was powered to show equivalence between the two active intervention groups, and superiority of both intervention groups over usual care. Secondary outcomes included patient-reported and physiological measures of asthma control, patient acceptability, and health-care costs. This trial was registered with International Standard Randomised Controlled Trial Number registry, number ISRCTN88318003., Findings: Between Nov 5, 2012 and Jan 28, 2014, invitations to participate in the study were sent to 15 203 patients with general practitioner-diagnosed asthma, of whom 655 were recruited into the study. AQLQ scores at 12 months were significantly higher in the DVDB group (mean 5·40, SD 1·14) than in the usual care group (5·12, SD 1·17; adjusted mean difference 0·28, 95% CI 0·11 to 0·44), and in the face-to-face group (5·33, SD 1·06) than in the usual care group (adjusted mean difference 0·24, 95% CI 0·04 to 0·44); AQLQ scores were similar between the DVDB group and the face-to-face group (0·04, 95% CI -0·16 to 0·24). There were no significant differences between the randomisation groups in FEV1 or fraction of exhaled nitric oxide. 744 adverse events occurred in 272 patients: 101 (39%) of 261 patients in the DVDB group, 55 (42%) of 132 patients in the face-to-face group, and 132 (50%) of 262 in the usual care group, with patients reporting one or more event. 11 (4%) patients in the DVDB group, four (3%) patients in the face-to-face group, and 20 (8%) patients in the usual care group had a serious adverse event., Interpretation: Breathing retraining programmes improve quality of life in patients with incompletely controlled asthma despite having little effect on lung function or airway inflammation. Such programmes can be delivered conveniently and cost-effectively as a self-guided digital audiovisual programme, so might also reduce health-care costs., Funding: UK National Institute of Health Research., (Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC-BY NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Long-term respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD) are common, and cause high levels of morbidity and mortality. Supporting self-management is advocated for both asthma and increasingly so for COPD, and there is growing interest in the potential role of a range of new technologies, such as smartphone apps, the web or telehealth to facilitate and promote self-management in these conditions. Treatment goals for both asthma and COPD include aiming to control symptoms, maintain activities, achieve the best possible quality of life and minimize risks of exacerbation. To do this, health professionals should be (a) helping patients to recognize deteriorating symptoms and act appropriately; (b) promoting adherence to maintenance therapy; (c) promoting a regular review where triggers can be established, and strategies for managing such triggers discussed; and (d) promoting healthy lifestyles and positive self-management of symptoms. In particular, low uptake of asthma action plans is a modifiable contributor to morbidity and possibly also to mortality in those with asthma and should be addressed as a priority. Using technology to support self-management is an evolving strategy that shows promise. This review provides an overview of self-management support and discusses how newer technologies may help patients and health professionals to meet key treatment goals.

On February 21, 2017, a European Respiratory Society research seminar held in Barcelona discussed how to best apply precision medicine to chronic airway diseases such as asthma and chronic obstructive pulmonary disease. It is now clear that both are complex and heterogeneous diseases, that often overlap and that both require individualised assessment and treatment. This paper summarises the presentations and discussions that took place during the seminar. Specifically, we discussed the need for a new taxonomy of human diseases, the role of different players in this scenario (exposome, genes, endotypes, phenotypes, biomarkers and treatable traits) and a number of unanswered key questions in the field. We also addressed how to deploy airway precision medicine in clinical practice today, both in primary and specialised care. Finally, we debated the type of research needed to move the field forward., Competing Interests: Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com, (Copyright ©ERS 2017.)

Self-management is an established, effective approach to controlling asthma, recommended in guidelines. However, promotion, uptake and use among patients and health-care professionals remain low. Many barriers and facilitators to effective self-management have been reported, and views and beliefs of patients and health care professionals have been explored in qualitative studies. We conducted a systematic review and thematic synthesis of qualitative research into self-management in patients, carers and health care professionals regarding self-management of asthma, to identify perceived barriers and facilitators associated with reduced effectiveness of asthma self-management interventions. Electronic databases and guidelines were searched systematically for qualitative literature that explored factors relevant to facilitators and barriers to uptake, adherence, or outcomes of self-management in patients with asthma. Thematic synthesis of the 56 included studies identified 11 themes: (1) partnership between patient and health care professional; (2) issues around medication; (3) education about asthma and its management; (4) health beliefs; (5) self-management interventions; (6) co-morbidities (7) mood disorders and anxiety; (8) social support; (9) non-pharmacological methods; (10) access to healthcare; (11) professional factors. From this, perceived barriers and facilitators were identified at the level of individuals with asthma (and carers), and health-care professionals. Future work addressing the concerns and beliefs of adults, adolescents and children (and carers) with asthma, effective communication and partnership, tailored support and education (including for ethnic minorities and at risk groups), and telehealthcare may improve how self-management is recommended by professionals and used by patients. Ultimately, this may achieve better outcomes for people with asthma.

Poor symptom control and impaired quality of life are common in adults with asthma, and breathing retraining exercises may be an effective method of self-management. This study aimed to explore the experiences of participants in the intervention arms of the BREATHE trial, which investigated the effectiveness of breathing retraining as a mode of asthma management. Sixteen people with asthma (11 women, 8 per group) who had taken part in the intervention arms of the BREATHE trial (breathing retraining delivered by digital versatile disc (DVD) or face-to-face sessions with a respiratory physiotherapist) took part in semi-structured telephone interviews about their experiences. Interviews were analysed using thematic analysis. Breathing retraining was perceived positively as a method of asthma management. Motivations for taking part included being asked, to enhance progress in research, to feel better/reduce symptoms, and to reduce medication. Participants were positive about the physiotherapist, liked having the materials tailored, found meetings motivational, and liked the DVD and booklet. The impact of breathing retraining following regular practice included increased awareness of breathing and development of new habits. Benefits of breathing retraining included increased control over breathing, reduced need for medication, feeling more relaxed, and improved health and quality of life. Problems included finding time to practice the exercises, and difficulty mastering techniques. Breathing retraining was acceptable and valued by almost all participants, and many reported improved wellbeing. Face to face physiotherapy was well received. However, some participants in the DVD group mentioned being unable to master techniques., Asthma: PATIENTS RECEPTIVE TO BREATHING RETRAINING: Patients with asthma taught how to change their unconscious breathing patterns generally like non-pharmacological interventions. Researchers in the UK, led by Mike Thomas from the University of Southampton, interviewed 16 people about their experiences in a trial that tested breathing retraining exercises delivered by DVD or face-to-face sessions with a respiratory physiotherapist. Overwhelmingly, trial participants reported that breathing retraining sessions gave them greater control over their symptoms, helped them relax, improved their quality of life and reduced the need for medications. Some participants who received DVD instruction said they had trouble mastering the techniques, and many in both groups found it hard to find time to practice the exercises. Overall, however, patients were positive about the experience. The authors conclude that breathing exercises are likely to be a well-received method of asthma management.

Background: Asthma control is suboptimal, resulting in quality of life (QoL) impairment and costs. Breathing retraining exercises have evidence of effectiveness as adjuvant treatment, but are infrequently used., Objectives: To transfer the contents of a brief (three-session) physiotherapist-delivered breathing retraining programme to a digital versatile disc (DVD) and booklet format; to compare the effectiveness of the self-guided intervention with that of 'face-to-face' physiotherapy and usual care for QoL and other asthma-related outcomes; to perform a health economic assessment of both interventions; and to perform a process evaluation using quantitative and qualitative methods., Design: Parallel-group three-arm randomised controlled trial., Setting: General practice surgeries in the UK., Participants: In total, 655 adults currently receiving asthma treatment with impaired asthma-related QoL were randomly allocated to the DVD ( n  = 261), physiotherapist ( n  = 132) and control (usual care) ( n  = 262) arms in a 2 : 1 : 2 ratio. It was not possible to blind participants but data collection and analysis were performed blinded., Interventions: Physiotherapy-based breathing retraining delivered through three 'face-to-face' respiratory physiotherapist sessions or a self-guided programme (DVD plus our theory-based behaviour change booklet) developed by the research team, with a control of usual care., Main Outcome Measures: The primary outcome measure was asthma-specific QoL, measured using the Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included asthma symptom control [Asthma Control Questionnaire (ACQ)], psychological state [Hospital Anxiety and Depression Scale (HADS)], hyperventilation symptoms (Nijmegen questionnaire), generic QoL [EuroQol-5 Dimensions (EQ-5D)], assessments of airway physiology (spirometry) and inflammation (exhaled nitric oxide) and health resource use and costs. Assessments were carried out at baseline and at 3, 6 and 12 months post randomisation. Patient engagement and experience were also assessed using quantitative and qualitative methods., Results: Primary efficacy analysis was between-group comparison of changes in AQLQ scores from baseline to 12 months in the intention-to-treat population with adjustments for prespecified covariates. Significant improvements occurred in the DVD group compared with the control group [adjusted mean difference 0.28, 95% confidence interval (CI) 0.11 to 0.44; p  < 0.001] and in the face-to-face physiotherapy group compared with the control group (adjusted mean difference 0.24, 95% CI 0.04 to 0.44; p  < 0.05), with equivalence between the DVD and the face-to-face physiotherapy groups (adjusted mean difference 0.04, 95% CI -0.16 to 0.24). In all sensitivity analyses, both interventions remained significantly superior to the control and equivalence between the interventions was maintained. In other questionnaire outcome measures and in the physiological measures assessed, there were no significant between-group differences. Process evaluations showed that participants engaged well with both of the active interventions, but that some participants in the DVD arm would have liked to receive tuition from a professional. Asthma health-care costs were lower in both intervention arms than in the control group, indicating 'dominance' for both of the interventions compared with the control, with lowest costs in the DVD arm. The rate of adverse events was lower in the DVD and face-to-face physiotherapy groups than in the control group., Conclusions: Only 10% of the potentially eligible population responded to the study invitation. However, breathing retraining exercises improved QoL and reduced health-care costs in adults with asthma whose condition remains uncontrolled despite standard pharmacological therapy, were engaged with well by patients and can be delivered effectively as a self-guided intervention. The intervention should now be transferred to an internet-based platform and implementation studies performed. Interventions for younger patients should be developed and trialled., Trial Registration: Current Controlled Trials ISRCTN88318003., Funding: This project was primarily funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 21, No. 53. See the NIHR Journals Library website for further project information. Additional financial support was received from Comprehensive Local Research Networks.

Background: In children with uncontrolled asthma prescribed low-dose inhaled corticosteroids (ICSs), various step-up options are available: fixed-dose combination ICS/long-acting β 2 -agonist (FDC), increasing ICS dose, or adding leukotriene receptor antagonist (LTRA). However, evidence of their relative effectiveness is limited., Objective: To compare the effectiveness of step-up treatment to FDC in children with asthma versus increased ICS dose, or LTRA., Methods: This matched cohort study used UK primary-care databases to study children prescribed their first step-up treatment to FDC, increased ICS dose, or LTRA. A year of baseline data was used for matching and identifying confounders. Outcomes over the following year were examined. The primary outcome was severe exacerbation rate; secondary outcomes included overall asthma control, derived from databases (no asthma-related admissions/hospital attendances/oral corticosteroids or antibiotics prescribed with a respiratory review, and average prescribed salbutamol ≤200 μg/day)., Results: There were 971 matched pairs in the FDC and increased ICS dose cohorts (59% males; mean age, 9.4 years) and 785 in the FDC and LTRA cohorts (60% males; mean age, 9.0 years). Exacerbation rates in the outcome year were similar between FDC and increased ICS (adjusted incidence rate ratio [95% CI], 1.09 [0.75-1.59]) and FDC and LTRA (incidence rate ratio, 1.36 [0.93-2.01]). Increased ICS and LTRA significantly reduced the odds of achieving overall asthma control, compared with FDC (odds ratios [95% CI], 0.52 [0.42-0.64] and 0.53 [0.42-0.66], respectively)-this was driven by reduced short-acting beta-agonist use., Conclusions: FDC is as effective as increased ICS or LTRA in reducing severe exacerbation rate, but more effective in achieving asthma control., (Copyright © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Asthma attacks are common, serious, and costly. Individual factors associated with attacks, such as poor symptom control, are not robust predictors., Objective: We investigated whether the rich data available in UK electronic medical records could identify patients at risk of recurrent attacks., Methods: We analyzed anonymized, longitudinal medical records of 118,981 patients with actively treated asthma (ages 12-80 years) and 3 or more years of data. Potential risk factors during 1 baseline year were evaluated using univariable (simple) logistic regression for outcomes of 2 or more and 4 or more attacks during the following 2-year period. Predictors with significant univariable association (P < .05) were entered into multiple logistic regression analysis with backward stepwise selection of the model including all significant independent predictors. The predictive accuracy of the multivariable models was assessed., Results: Independent predictors associated with future attacks included baseline-year markers of attacks (acute oral corticosteroid courses, emergency visits), more frequent reliever use and health care utilization, worse lung function, current smoking, blood eosinophilia, rhinitis, nasal polyps, eczema, gastroesophageal reflux disease, obesity, older age, and being female. The number of oral corticosteroid courses had the strongest association. The final cross-validated models incorporated 19 and 16 risk factors for 2 or more and 4 or more attacks over 2 years, respectively, with areas under the curve of 0.785 (95% CI, 0.780-0.789) and 0.867 (95% CI, 0.860-0.873), respectively., Conclusions: Routinely collected data could be used proactively via automated searches to identify individuals at risk of recurrent asthma attacks. Further research is needed to assess the impact of such knowledge on clinical prognosis., (Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Asthma is a heterogeneous, complex disease with clinical phenotypes that incorporate persistent symptoms and acute exacerbations. It affects many millions of Europeans throughout their education and working lives and puts a heavy cost on European productivity. There is a wide spectrum of disease severity and control. Therapeutic advances have been slow despite greater understanding of basic mechanisms and the lack of satisfactory preventative and disease modifying management for asthma constitutes a significant unmet clinical need. Preventing, treating and ultimately curing asthma requires co-ordinated research and innovation across Europe. The European Asthma Research and Innovation Partnership (EARIP) is an FP7-funded programme which has taken a co-ordinated and integrated approach to analysing the future of asthma research and development. This report aims to identify the mechanistic areas in which investment is required to bring about significant improvements in asthma outcomes., Competing Interests: Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com, (Copyright ©ERS 2017.)

Inhaler device errors are common and may impact the effectiveness of the delivered drug. There is a paucity of up-to-date systematic reviews (SRs) or meta-analyses (MAs) of device errors in asthma and chronic obstructive pulmonary disease (COPD) patients. This SR and MA provides an estimate of overall error rates (both critical and non-critical) by device type and evaluates factors associated with inhaler misuse. The following databases from inception to July 23, 2014 (Embase®, MEDLINE®, MEDLINE® In-Process and CENTRAL) were searched, using predefined search terms. Studies in adult males and females with asthma or COPD, reporting at least one overall or critical error, using metered dose inhalers and dry powder inhalers were included. Random-effect MAs were performed to estimate device error rates and to compare pairs of devices. Overall and critical error rates were high across all devices, ranging from 50-100% and 14-92%, respectively. However, between-study heterogeneity was also generally >90% (I-squared statistic), indicating large variability between studies. A trend towards higher error rates with assessments comprising a larger number of steps was observed; however no consistent pattern was identified. This SR and MA highlights the relatively limited body of evidence assessing device errors and the lack of standardised checklists. There is currently insufficient evidence to determine differences in error rates between different inhaler devices and their impact on clinical outcomes. A key step in improving our knowledge on this topic would be the development of standardised checklists for each device., Chronic Lung Diseases: CALL TO STANDARDISE RESEARCH INTO INHALER DEVICE ERRORS: Researchers should adopt a standardised approach to investigate the incorrect use of inhalers and its associated clinical implications. Henry Chrystyn at Plymouth University, together with scientists across the UK and the Netherlands, conducted a review of research related to inhaled medication errors made by patients with asthma or chronic obstructive pulmonary disease. It is widely acknowledged that many patients with lung conditions don't use their inhaler devices correctly, which affects drug effectiveness and disease control. While Chrystyn's team found high critical error rates reported across all devices, their meta-analysis and systematic review highlighted significant gaps in knowledge regarding different inhalers and associated error rates, and how these affect clinical outcomes. The researchers call for in-depth studies into device use, alongside standardised checklists and definitions for such studies to use to ensure consistency.

Competing Interests: AS is joint Editor-in-Chief of npjPCRM. He was not involved in the editorial decision making with respect to this protocol. The remaining authors declare no conflict of interest.

Background: Adding a long-acting β 2 -agonist (LABA) to inhaled corticosteroids (ICS) using a fixed-dose combination (FDC) inhaler is the UK guideline recommendation for children aged more than 4 years with uncontrolled asthma. The evidence of benefit of adding an FDC inhaler over a separate LABA inhaler is limited., Objective: The objective of this study was to compare the effectiveness of a LABA added as an FDC inhaler, and as a separate inhaler, in children with uncontrolled asthma., Methods: Two UK primary care databases were used to create a matched cohort study with a 2-year follow-up period. We included children prescribed their first step-up from ICS monotherapy. Two cohorts were formed for children receiving an add-on LABA as an FDC inhaler, or a separate LABA inhaler. Matching variables and confounders were identified by comparing characteristics during a baseline year of follow-up. Outcomes were examined during the subsequent year. The primary outcome was an adjusted odds ratio for overall asthma control (defined as follows: no asthma-related hospital admission or emergency room visit, prescription for oral corticosteroids or antibiotic with evidence of respiratory consultation, and ≤2 puffs of short-acting β-agonist daily)., Results: The final study consisted of 1330 children in each cohort (mean age 9 years; 59% male). In the separate ICS+LABA cohort, the odds of achieving overall asthma control were lower (adjusted odds ratio, 0.77 [95% confidence interval, 0.66-0.91]; P = .001) compared with the FDC cohort., Conclusion: The study demonstrates a small but significant benefit in achieving asthma control from an add-on LABA as an FDC, compared with a separate inhaler and this supports current guideline recommendations., (Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Errors in the use of different inhalers were investigated in patients naive to the devices under investigation in a multicentre, single-visit, randomised, open-label, cross-over study. Patients with chronic obstructive pulmonary disease (COPD) or asthma were assigned to ELLIPTA vs DISKUS (Accuhaler), metered-dose inhaler (MDI) or Turbuhaler. Patients with COPD were also assigned to ELLIPTA vs Handihaler or Breezhaler. Patients demonstrated inhaler use after reading the patient information leaflet (PIL). A trained investigator assessed critical errors (i.e., those likely to result in the inhalation of significantly reduced, minimal or no medication). If the patient made errors, the investigator demonstrated the correct use of the inhaler, and the patient demonstrated inhaler use again. Fewer COPD patients made critical errors with ELLIPTA after reading the PIL vs: DISKUS, 9/171 (5%) vs 75/171 (44%); MDI, 10/80 (13%) vs 48/80 (60%); Turbuhaler, 8/100 (8%) vs 44/100 (44%); Handihaler, 17/118 (14%) vs 57/118 (48%); Breezhaler, 13/98 (13%) vs 45/98 (46%; all P<0.001). Most patients (57-70%) made no errors using ELLIPTA and did not require investigator instruction. Instruction was required for DISKUS (65%), MDI (85%), Turbuhaler (71%), Handihaler (62%) and Breezhaler (56%). Fewer asthma patients made critical errors with ELLIPTA after reading the PIL vs: DISKUS (3/70 (4%) vs 9/70 (13%), P=0.221); MDI (2/32 (6%) vs 8/32 (25%), P=0.074) and significantly fewer vs Turbuhaler (3/60 (5%) vs 20/60 (33%), P<0.001). More asthma and COPD patients preferred ELLIPTA over the other devices (all P⩽0.002). Significantly, fewer COPD patients using ELLIPTA made critical errors after reading the PIL vs other inhalers. More asthma and COPD patients preferred ELLIPTA over comparator inhalers., Competing Interests: JvdP has no shares in any pharmaceutical companies. He has received sponsorship to carry out studies and has participated in Advisory Boards from several pharmaceutical companies that market inhaled products. These include Almirall, Boehringer Ingelheim (BI), GlaxoSmithKline (GSK), Mundipharma and Teva. Neither MT nor any member of his close family has any shares in pharmaceutical companies. In the past 3 years, he has received speaker’s honoraria for speaking at sponsored meetings or satellite symposia at conferences from the following companies marketing respiratory and allergy products: Aerocrine, AstraZeneca, BI, GSK, Teva and Novartis. He has received honoraria for attending advisory panels with: Aerocrine, Almirall, AstraZeneca, BI, Chiesi, GSK, MSD, Novartis, Pfizer, Roche and Sandoz. He has received sponsorship to attend international scientific meetings from: GSK and AstraZeneca. He has received funding for research projects from GSK. He is a member of the BTS SIGN Asthma guideline group and the NICE Asthma guideline group. HC has no shares in any pharmaceutical companies. He has received sponsorship from several pharmaceutical companies that market inhaled products to carry out: clinical studies, Board Membership, consultant agreements and honoraria for presentations. These include Almirall, AstraZeneca, BI, Chiesi, GSK, Innovata Biomed, Meda, Napp Pharmaceuticals, Mundipharma, NorPharma, Norvartis, Orion, Sanofi, Teva, Truddell Medical International, UCB and Zentiva. Research sponsorship has also been received from grant awarding bodies (EPSRC and MRC). He is the owner of Inhalation Consultancy Ltd and a director of Talmedica Ltd. TW has received research funding and consultancy fees from GSK, AstraZeneca and BI. He is a Director of my mHealth Ltd. CS has no shares in any pharmaceutical companies. She has received consultant agreements and honoraria for presentations from several pharmaceutical companies that market inhaled medication. These include AstraZeneca, Chiesi, GSK, Napp Pharmaceuticals and Teva. NB, RS, VI, HS and C-QZ are employees of GSK and hold stock in GSK. The remaining authors declare no conflict of interest.

Background: Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of asthma. The widespread use of an asthma self-management plan, designed to encourage disease monitoring and timely intervention, can reduce exacerbations and is, therefore, recommended for all patients with asthma. Unfortunately, the majority of patients are not provided with such a plan. There are a variety of reasons for this but uncertainty about what to include in the plan when asthma control is deteriorating, but before the need for orally administered corticosteroids, is a contributing factor. The aim of this trial is to determine whether an asthma self-management plan, which includes a temporary quadrupling of the dose of inhaled corticosteroid when asthma control starts to deteriorate, reduces asthma exacerbations requiring orally administered corticosteroids or unscheduled health care consultation for asthma., Methods: A multicentre, pragmatic, randomised trial in adults aged over 16 years with a clinical diagnosis of asthma, treated with a licensed dose of inhaled corticosteroid and at least one exacerbation in the previous 12 months requiring treatment with systemic corticosteroids. Participants will be randomised to either a self-management plan, which includes a temporary (maximum of 14 days) fourfold increase in inhaled corticosteroid or the same plan without an increase in inhaled corticosteroid. Participants will be followed up at 6 and 12 months and will attend the clinic for an additional visit if their asthma control deteriorates. The primary outcome is time to first asthma exacerbation, defined as the need for systemic corticosteroids and/or unscheduled health care consultation for asthma. The estimated sample size is 1800 participants., Discussion: The FAST trial is an independent study that has been prioritised and commissioned by the National Institute for Health Research (NIHR) in the United Kingdom. It will provide high-quality evidence to inform clinical decision-making on the role of an asthma self-management plan, which includes a temporary fourfold increase of inhaled corticosteroid, when asthma control starts to deteriorate. The first participant was randomised on 17th May 2013 and recruitment will close on 31 January 2016 with the last patient last visit taking place in January 2017., Trial Registration: ISRCTN: 15441965 , registered on 25 April 2013.

Background: To identify, summarise and synthesise the evidence for using interactive digital interventions to support patient self-management of asthma, and determine their impact., Methods: Systematic review with meta-analysis. We searched MEDLINE, EMBASE, CINAHL, PsycINFO, ERIC, Cochrane Library, DoPHER, TROPHI, Social Science Citation Index and Science Citation Index. The selection criteria requirement was studies of adults (16 years and over) with asthma, interventions that were interactive digital interventions and the comparator was usual care. Outcomes were change in clinical outcomes, cost effectiveness and patient-reported measures of wellbeing or quality of life. Only Randomised Controlled Trials published in peer-reviewed journals in English were eligible. Potential studies were screened and study characteristics and outcomes were extracted from eligible papers independently by two researchers. Where data allowed, meta-analysis was performed using a random effects model., Results: Eight papers describing 5 trials with 593 participants were included, but only three studies were eligible for inclusion for meta-analysis. Of these, two aimed to improve asthma control and the third aimed to reduce the total dose of oral prednisolone without worsening control. Analyses with data from all three studies showed no significant differences and extremely high heterogeneity for both Asthma Quality of Life (AQLQ) (Standardised Mean Difference (SMD) 0.05; 95 % Confidence Interval (CI) 0.32 to -0.22: I2 96.8) and asthma control (SMD 0.21; 95 % CI -0.05 to .42; I2 = 87.4). The removal of the third study reduced heterogeneity and indicated significant improvement for both AQLQ (SMD 0.45; 95 % CI 0.13 to 0.77: I2 = 0.34) and asthma control (SMD 0.54; 95 % CI 0.22 to 0.86: I2 = 0.11). No evidence of harm was identified., Conclusion: Digital self-management interventions for adults with asthma show promise, with some evidence of small beneficial effects on asthma control. Overall, the evidence base remains weak due to the lack of large, robust trials.

Asthma and chronic obstructive pulmonary disease (COPD) are two prevalent chronic airway diseases that have a high personal and social impact. They likely represent a continuum of different diseases that may share biological mechanisms (i.e. endotypes), and present similar clinical, functional, imaging and/or biological features that can be observed (i.e. phenotypes) which require individualised treatment. Precision medicine is defined as "treatments targeted to the needs of individual patients on the basis of genetic, biomarker, phenotypic, or psychosocial characteristics that distinguish a given patient from other patients with similar clinical presentations". In this Perspective, we propose a precision medicine strategy for chronic airway diseases in general, and asthma and COPD in particular., (Copyright ©ERS 2016.)

Background: Elevated sputum eosinophil counts predict asthma exacerbations and responsiveness to inhaled corticosteroids but are impractical to measure in primary care. We investigated the relation between blood eosinophil count and prospective annual asthma outcomes for a large UK cohort., Methods: This historical cohort study used anonymised medical record data to identify primary care patients with asthma aged 12-80 years with 2 years of continuous records, including 1 year before (baseline) and 1 year after (outcome) their most recent eosinophil count. Negative binomial regression was used to compare outcome exacerbation rates and logistic regression to compare odds of asthma control for patients with blood eosinophil counts of 400 cells per μL or less versus greater than 400 cells per μL, adjusting for age, sex, body-mass index, smoking status, and Charlson comorbidity index. The study is registered at ClinicalTrials.gov, number NCT02140541., Findings: Overall, 20 929 (16%) of 130 248 patients had blood eosinophil counts greater than 400 cells per μL. During the outcome year, these patients experienced significantly more severe exacerbations (adjusted rate ratio [RR] 1·42, 95% CI 1·36-1·47) and acute respiratory events (RR 1·28, 1·24-1·33) than those with counts of 400 cells per μL or less. They also had significantly lower odds of achieving overall asthma control (OR 0·74, 95% CI 0·72-0·77), defined as limited reliever use and no asthma-related hospital attendance or admission, acute course of oral corticosteroids, or prescription for antibiotics. Exacerbation rates increased progressively with nine ascending categories of blood eosinophil count as compared with a reference category of 200 cells per μL or less., Interpretation: Patients with asthma and blood eosinophil counts greater than 400 cells per μL experience more severe exacerbations and have poorer asthma control. Furthermore, a count-response relation exists between blood eosinophil counts and asthma-related outcomes. Blood eosinophil counts could add predictive value to Global Initiative for Asthma control-based risk assessment., Funding: Teva Pharmaceuticals., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Around 300 million people worldwide have asthma and prevalence is increasing. Self-management can be effective in improving a range of outcomes and is cost effective, but is underutilised as a treatment strategy. Supporting optimum self-management using digital technology shows promise, but how best to do this is not clear. We aimed to develop an evidence based, theory informed, online resource to support self-management in adults with asthma, called 'Living well with Asthma', as part of the RAISIN (Randomized Trial of an Asthma Internet Self-Management Intervention) study., Methods: We developed Living well with Asthma in two phases. Phase 1: A low fidelity prototype (paper-based) version of the website was developed iteratively through input from a multidisciplinary expert panel, empirical evidence from the literature, and potential end users via focus groups (adults with asthma and practice nurses). Implementation and behaviour change theories informed this process. Phase 2: The paper-based designs were converted to a website through an iterative user centred process. Adults with asthma (n = 10) took part in think aloud studies, discussing the paper based version, then the web-based version. Participants considered contents, layout, and navigation. Development was agile using feedback from the think aloud sessions immediately to inform design and subsequent think aloud sessions. Think aloud transcripts were also thematically analysed, further informing resource development., Results: The website asked users to aim to be symptom free. Key behaviours targeted to achieve this include: optimising medication use (including inhaler technique); attending primary care asthma reviews; using asthma action plans; increasing physical activity levels; and stopping smoking. The website had 11 sections, plus email reminders, which promoted these behaviours. Feedback on the contents of the resource was mainly positive with most changes focussing on clarification of language, order of pages and usability issues mainly relating to navigation difficulties., Conclusions: Our multifaceted approach to online intervention development underpinned by theory, using evidence from the literature, co-designed with end users and a multidisciplinary panel has resulted in a resource which end users find relevant to their needs and easy to use. Living well with Asthma is undergoing evaluation within a randomized controlled trial.

Background: When standard doses of inhaled corticosteroids (ICS) fail to control symptoms in children aged >4 years, guidelines recommend the addition of a long-acting β2-agonist (LABA), with other treatment options being available if symptoms persist., Aims: To determine the proportion of initial 'step-up' episodes where LABAs were prescribed and to describe characteristics of individuals not stepped up with LABA., Methods: Between 1999 and 2011, initial step-up episodes from ICS monotherapy were identified in children aged 5-12 years with asthma and in receipt of ICS. Data sources were the Clinical Practice Research Datalink and Optimum Patient Care Research Database., Results: Initial step-up episodes were identified in 10,793 children. ICS dose was increased in 6,252 children (58%), LABA was introduced in 3,436 (32%; including 1,107 where fixed dose combination inhaler (FDC) replaced the ICS inhaler), and leukotriene receptor antagonist (LTRA) was added in 1,105 (10%). Compared with children stepped up to any LABA, others were younger and prescribed lower doses of ICS and reliever medication. ICS dose increase was more likely in obese children and LTRA prescribing was more likely in children with rhinitis and in receipt of antibiotics. Compared with FDC, step-up to separate LABA inhaler was more likely in younger, obese children who were using less oral steroids., Conclusions: One-third of initial step-up episodes in children with asthma treated with ICS are to add LABA. Different characteristics of children prescribed therapies other than LABA suggest that prescribers tailor treatment in some clinical settings.