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The effectiveness of inhalation therapy can be significantly reduced by a number of problems. For example, inhalation technique errors can reduce the dose delivered by 22-95% compared to the optimal value in patients with technical errors in the use of the inhaler. Sub-optimal inspiratory flow rates in a number of patients with chronic obstructive pulmonary disease and asthma are often the cause of technical errors during inhalation. Patient education does not produce the expected results, as the underlying cause of reduced flow is high hyperinflation and weakening of the respiratory musculature. The use of technologically outdated inhalers is another significant cause of reduced therapy effectiveness. Patient education and even conversion to a different inhaler do not always increase the effectiveness of therapy. Respimat, a brand new delivery agent introduced in 2004, allows 39% to 67% of the nominal dose to be delivered to the airways, while the degree of pulmonary deposit is independent of inspiratory flow and pulmonary drug deposit does not decrease with increasing obstruction. Compared to powder inhalers, Respimat creates less resistance to airflow on inhalation. In addition, Respimat is an active device that requires no effort on the part of the patient to move the aerosol particles. These features make Respimat the new standard for inhalation therapy. This review aims to familiarise readers with the main features of the Respimat and the latest research findings

Background: The aim of this study was to investigate inhaler device handling in elderly patients. Inhaler devices with respect to misuse and error correction were also compared. Methods: Inhaler use technique was assessed using standardized checklists at the first visit and 3-month follow-up visit after retraining. The primary outcome was difference in the acceptable use ratio among inhaler devices. Secondary outcomes included differences in error correction, the most common step of misuse, and factors affecting the accuracy of inhaler use. Results: A total of 251 patients (mean age, 76.4 years) were included. The handling of 320 devices was assessed in the study. All patients had been trained before. However, only 24.7% of them used inhalers correctly. Proportions of acceptable use for Evohaler, Respimat, Turbuhaler, Ellipta, and Breezhaler/Handihaler were 38.7%, 50.0%, 61.4%, 60.8%, and 43.2%, respectively (p=0.026). At the second visit, the acceptable use ratio had increased. There were no significant differences among inhaler types (Evohaler, 63.9%; Respimat, 86.1%; Turbuhaler, 74.3%; Ellipta, 64.6%; and Breezhaler/ Handihaler, 65.3% [p=0.129]). In multivariate analysis, body mass index, Turbuhaler, and Ellipta showed positive correlations with acceptable use of inhalers, whereas Chronic Obstructive Pulmonary Disease Assessment Test score showed a negative correlation. Conclusion: Although new inhalers have been developed, the accuracy of inhaler use remains low. Elderly patients showed more errors when using pressurized metered-dose inhalers than using dry powder inhalers and soft-mist inhalers. However, there were no significant differences in misuse among inhaler devices after individual training. Results of this study suggests that repeat training is more important than inhaler type.

Tiotropium and olodaterol are mainstay treatments for chronic obstructive pulmonary disease (COPD) and yield important clinical improvements, especially when used in fixed-dose combination. Whilst previous studies have shown consistent delivery of tiotropium to the lungs with the Respimat® inhaler, no such study has been carried out for olodaterol or the components of their fixed-dose combination (TIO/OLO). Combining in vitro and in silico models, we measured the amount of drug retained in the mouth–throat area, entering the trachea and reaching the lung periphery. We applied a hybrid deposition model that considered the experimentally determined output of an Alberta throat model (in vitro – dose to lung) combined with a computational fluid dynamic model of the lungs (in silico). Regardless of the COPD breathing pattern, ≥50% of the nominal dose of either tiotropium, olodaterol, or TIO and OLO in the fixed-dose combination reached the lung. Of the dose reaching the lungs, greater than 50% is deposited in the lung periphery (from generation 8 onwards). Our study demonstrated that aerosol delivery via the Respimat inhaler achieved high deposition deep into the lung periphery with all formulations evaluated.

Background: Inhalation therapy is a cornerstone of treating patients with chronic obstructive pulmonary disease (COPD). Inhaler types and through-device inhalation parameters influence airway drug delivery. We aimed to measure the repeatability of inhalation performance through four different commercially available inhalers. Methods: We recruited control subjects (n = 22) and patients with stable COPD (S-COPD, n = 16) and during an acute exacerbation (AE-COPD, n = 15). Standard spirometry was followed by through-device inhalation maneuvers using Ellipta(®), Evohaler(®), Respimat(®), and Genuair(®). Through-device inspiratory vital capacity (IVC(d)) and peak inspiratory flow (PIF(d)), as well as inhalation time (t(in)) and breath hold time (t(bh)), were recorded and all measurements were repeated in a random manner. Results: There was no difference in forced expiratory volume in 1 second (FEV(1)) between patients (S-COPD: 39 ± 5 vs. AE-COPD: 32% ± 5% predicted, p > 0.05). In controls, the IVC(d) was significantly reduced by all four devices in comparison with the slight reduction seen in COPD patients. In all subjects, PIF was lowered when inhaling through the devices in order of decreasing magnitude in PIF(d): Evohaler, Respimat, Ellipta, and Genuair. The Bland-Altman analysis showed a highly variable coefficient of repeatability for IVC(d) and PIF(d) through the different inhalers for all COPD patients. Based on the intermeasurement differences in patients, Respimat and Genuair showed the highest repeatability for IVC(d), while Genuair and Ellipta performed superior with regard to PIF(d). Conclusions: Our study is the first to compare repeatability of inhalation performances through different inhalers in COPD patients, showing great individual differences for parameters influencing lung deposition of inhaled medication from a given device. Our data provide new insight into the characterization of inhaler use by patients with COPD, and might aid the selection of the most appropriate devices to ensure the adequate and consistent delivery of inhaled drugs.

Chronic obstructive pulmonary disease (COPD) is a progressive disease requiring maintenance therapy. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report, bronchodilation with long-acting muscarinic antagonists (LAMAs) and long-acting β2-agonists (LABAs), administered via inhalers, is currently the mainstay of COPD treatment. Combined LAMA/LABA therapies have been shown to improve patient health status, lung function and breathlessness. Here, we wanted to report patient satisfaction with the Respimat® Soft Mist™ inhaler (SMI). This was a pooled analysis of SPIRIT® (NCT02675517) and OTIVACTO® (NCT02719639), two open-label, single-arm, non-interventional studies of physical function in patients with COPD. Patients were treated with tiotropium/olodaterol 5/5 μg for approximately 6 weeks via the SMI. SPIRIT was conducted in Germany; OTIVACTO was conducted in nine European countries. The primary endpoints have been reported previously. Here, we assess patient satisfaction with inhalation and handling, and patient adherence to treatment with the tiotropium/olodaterol SMI in patients with COPD. These were assessed through self-reported questionnaires and physician general assessments. Baseline data were collected from 9180 patients from the SPIRIT and OTIVACTO studies. The majority of patients were GOLD group A (25.59%) or B (46.12%). After 6 weeks of treatment with tiotropium/olodaterol, 85.78% of patients were ‘satisfied’ or ‘very satisfied’ with inhaling from the device, and 84.33% of patients were ‘satisfied’ or ‘very satisfied’ with the handling of the inhaler. Treating physicians reported patient adherence as ‘high’ during the study, with 98.57% of patients regularly using the tiotropium/olodaterol SMI. Furthermore, 95.45% of patients expressed a willingness to continue using the tiotropium/olodaterol SMI at the end of the observation period. In this study, over 9000 patients reported satisfaction with respect to inhalation and handling of the Respimat SMI, and patient adherence was high. ClinicalTrials.gov: NCT02675517 (SPIRIT) and NCT02719639 (OTIVACTO). Inhalation devices are the main method of delivering treatments to patients with chronic obstructive pulmonary disease (COPD). However, there are many devices available, which can lead to confusion and poor inhaler technique. To help doctors decide which device to give to their patients, they consider whether the patient would be happy with the device and whether they can use it correctly. This study pooled data from two large real-life studies to assess patient satisfaction with the Respimat® Soft Mist™ inhaler. Patients assessed their satisfaction and willingness to continue using the device at the end of the study period. The pooled data included over 9000 patients on a range of baseline therapies. After 6 weeks of using the trial device, over 85% of patients were satisfied or very satisfied with inhaling from the device, and over 84% were satisfied with the handling of the device. Physicians reported that nearly 99% of patients regularly used their device. Also, over 95% of the patient population reported that they continued using the inhaler at the end of the study. Overall, these results support the view that many patients with COPD across a wide range of severities and baseline characteristics demonstrated satisfaction with the Respimat® Soft Mist™ inhaler to control their disease.

Introduction: Pneumonia is one of the most frequently occurring complications after esophagectomy and is associated with increased operative mortality. Chronic obstructive pulmonary disease (COPD) is known to be a risk factor for pulmonary complications and operative mortality. However, in COPD patients preparing for esophagectomy, preventive measures against postoperative pneumonia have not yet been discovered. In this study, we evaluate the effect of perioperative inhaled tiotropium, a long-acting, antimuscarinic bronchodilator used in the management of COPD, on patients with COPD who undergo esophageal cancer surgery. Methods/Design: This study investigates the effect of perioperative inhaled tiotropium on patients with COPD who undergo esophagectomy. It is an open-label, randomized controlled trial conducted in a single center (EPITOPE study). A total of 32 enrolled patients are randomly assigned in a 1:1 ratio to either conventional management or inhalation of tiotropium in addition to the conventional management. Patients included in the intervention group receive tiotropium Respimat 5 μg (two inhalations of 2.5 μg) for at least 2 weeks before the esophagectomy. Following the esophagectomy, tiotropium is re-delivered, starting as early as possible and continuing until the postoperative evaluation (between 30 and 44 days after the operation). The primary outcome is the incidence of pneumonia within 30 days after esophagectomy. Secondary outcomes are the incidence of cardiovascular complications within 30 days after esophagectomy, the incidence of any postoperative complications within 30 days after esophagectomy, pulmonary function (preintervention, preoperative, and postoperative), walking distance in the incremental shuttle walking test (preintervention, preoperative, and postoperative), the incidence of adverse events, and mortality within 30 days after esophagectomy. Discussion: The EPITOPE study is the first pilot study on the effects of perioperative inhaled tiotropium on patients with COPD undergoing esophagectomy. After completing this study, we will plan a multicenter RCT with the appropriate outcomes in the future.

Patients with COPD often have reduced physical activity, which can impair health status. Real-world data can provide valuable information on the health and functional status of patients with COPD treated with tiotropium/olodaterol. AERIAL® (ClinicalTrials.gov NCT03165045) was a German, non-interventional study of patients with COPD receiving treatment with tiotropium/olodaterol under real-world conditions for ∼6 weeks. The primary end-point was the proportion of patients achieving a decrease of ≥0.4 points in Clinical COPD Questionnaire (CCQ) score. The CCQ-4 subdomain was used to assess functional status, and the Physician's Global Evaluation (PGE) scale was used to assess the patients’ general condition. Safety was assessed, as well as patient satisfaction and willingness to continue treatment. Out of 1351 screened patients, 1322 were treated and 1140 comprised the full analysis set. The primary end-point was met: 66.3% of patients achieved a ≥0.4-point decrease in overall CCQ score (mean±sd decrease 0.78±0.95). Mean±sd decreases in CCQ symptoms and functional state subdomains were 0.84±1.06 and 0.75±1.05 points, respectively. PGE scores improved. One fatality (not treatment-related) and 23 drug-related adverse events were recorded, most commonly nausea and vertigo. >85% of patients were satisfied/very satisfied with tiotropium/olodaterol overall and with the Respimat® device, both in terms of inhalation and handling. Most patients (95.2%) expressed willingness to continue treatment. Patients with COPD treated with tiotropium/olodaterol via Respimat® in routine clinical practice had clinically relevant improvements in health and functional status compared with baseline., The AERIAL non-interventional study demonstrated that patients with COPD treated with tiotropium/olodaterol via Respimat in routine clinical practice had high product satisfaction and clinically relevant improvements in health and functional status https://bit.ly/3jf6hIf

The aims of the survey were to assess first experiences of Swiss COPD patients switching from the disposable to the new reusable Respimat inhaler, and to evaluate physicians´ and patients´ views of the new training material.Patients with a confirmed diagnosis of COPD using a disposable Respimat inhaler for at least three months were included. Patients´ demographics, COPD stage, current treatment, and comorbidities relevant for the handling of the device were assessed. Further, patients were trained on the reusable Respimat by placebo inhaler, patient brochure, video cards/demo films and SMS reminder service. After at least one cartridge change, patients gave comprehensive feedback on their satisfaction with the reusable Respimat and physicians evaluated the need for re-training.235 patients participated in the survey. Of these, 37% suffered from comorbidities restricting the handling of the Respimat. 216 (92%) patients had a better overall satisfaction with the reusable than with the disposable Respimat. Dose counter (86%), monthly preparation (81%) and daily handling (77%) were also assessed as better by most of the patients. In 80% of cases, the user ability was stated as better than for the disposable Respimat. Less than 15% of the patients required further training. Placebo inhaler was the mostly preferred training material by both, physicians (in 86% of the patients) and patients (75%). In patients with comorbidities affecting inhaler handling, overall satisfaction was also better in 86% of the patients.The majority of patients were satisfied with the new reusable Respimat device and proper handling could be attained using the provided training material, even in patients with restricting comorbidities.

Small airway disease is recognized as a cardinal pathological process of chronic obstructive pulmonary disease (COPD), and recently small airways have been recognized as a major site of airflow obstruction also in asthmatic patients. The transversal involvement of small airways in COPD and asthma has warranted research efforts to identify therapeutic strategies able to unlock the small airway compartment. The mainstay of COPD treatment is represented by long-acting β2-adrenoceptor agonists (LABAs) and long-acting muscarinic antagonists (LAMAs). In asthma, the efficacy of LAMAs administered add-on to inhaled corticosteroids (ICSs) or ICS/LABA combinations has been investigated only in recent years. The aim of this systematic review was to examine the current literature concerning the impact of LAMAs on small airways and their lung deposition in both COPD and asthma. LAMAs administered either alone or in combination induced an effective bronchorelaxant effect of small airways, however the effectiveness of respiratory medications not only relies on the selected drug, but also on the employed inhalation device and patient's adherence. Tiotropium delivered via Respimat® SMI achieved a superior drug deposition in the peripheral lung compared to HandiHaler® dry powder inhaler and metered-dose inhalers (MDIs). The use of co-suspension™ delivery technology for MDIs and the introduction of the eFlow® nebulizer to deliver glycopyrronium improved aerosol drug delivery to the peripheral lung, by achieving uniform distribution of drug particles. This systematic review provides a synthesis of current literature concerning the impact of LAMAs on small airways and an insight on LAMAs distribution within the lung.

Background. Bronchial asthma (BA) is a heterogeneous chronic inflammatory disease of the airways. On the base of this heterogeneity, among other factors, a significant role is played by the type of inflammation (eosinophilic, neutrophilic or malogranulocytic). In this regard it is offered to allocate separate endotypes of the disease. BA with a neutrophilic type of inflammation is characterized by more severe course with the presence of obstruction at the level of small bronchi and fixed bronchoobstruction. In the presence of disorders at the level of small bronchi, it is advisable to prescribe anti-inflammatory drugs in delivery devices that can create a high concentration of drugs in the peripheral departments (eg, Respimat, inhaled inhalers, fine aerosols). Mucolytics disrupt the structure of the mucus gel, thereby reducing its viscosity and elasticity and, thus, improving the viscoelastic properties of sputum, which facilitate airway clearance and promote the targeted delivery of bronchodilators and anti-inflammatory drugs to the small bronchi. Objective. To evaluate the effectiveness of the use of ultrafine-particle glucocorticoid tiotropium bromide through Respimat in standard therapeutic doses and inhalation of a10 % solution of acetylcysteine with a nebulizer once a day for 10 days as basic therapy. Materials and methods. The diagnosis of BA with the neutrophilic type of inflammation was established in patients, whose results of the blood analysis by microscopy showed the level of neutrophils ≥4000 in 1 μl. The effectiveness of treatment of patients having BA with neutrophilic type of inflammation was studied in 30 patients. First (control) group consisted of 15 patients (5 men and 10 women, mean age – 53.2±4.9 years, FEV1 after test with a bronchodilator – 50.6±16.3 %, FEV1/FVC – 66.4±17,8), who received as a standard therapy a combined drug – 320 mcg of budesonide and 9 mcg of formoterol – twice a day in complex treatment. Second (main) group consisted of 15 patients (9 men and 6 women, mean age – 53.6±3.8 years, FEV1 – 51.5±4.7 %, FEV1/FVC – 67,2±3,5), who were administered the inhalation of 250 μg of ultrafine-particle beclomethasone dipropionate and 12 μg of formoterol twice a day, 5 mcg tiotropium bromide as inhalations through the delivery device respimat once a day for 3 months. In the complex treatment, the inhalation of acetylcysteine (3 ml of 10 % solution) with a nebulizer once a day in the morning (duration of an inhalation session – 10 min) for 10 days was additionally prescribed. Results and discussion. After 3 months in patients of group 2, the effectiveness of treatment was 93.3 %. There was a statistically significant increase in the total score of the test for asthma control (ACT) from 14.3±1.3 to 20.3±0.8 points (p

Background RESPIMAT® re-usable enables patients to re-use the inhaler and its availability therefore reduces the number of inhalers and associated wastage. Objective The objective of this study was to perform an economic evaluation that incorporates the ecological impact of adopting RESPIMAT re-usable into the healthcare system in Germany. Methods Inhaler costs and environmental impact over 5 years in Germany in a scenario with RESPIMAT re-usable compared to a scenario without RESPIMAT re-usable were estimated using a budget impact model. The carbon emissions were derived for each treatment pattern considering the whole life cycle (cradle-to-grave) of the inhaler product. The cost of carbon emissions was estimated using a societal cost per ton of carbon emission. Results By introducing RESPIMAT re-usable in Germany, it was estimated that by 2023, the number of inhalers used would have decreased by 5,748,750 compared to a scenario without RESPIMAT re-usable. In addition, this measure would reduce the environmental burden of inhaler use while at the same time reducing medical cost of inhalers. Conclusions Adopting RESPIMAT® re-usable to the national healthcare services may be a cost-saving option, which has the additional benefit of reducing the societal cost of carbon emissions.

Introduction The healthcare sector contributes 5–8% of the global greenhouse gas emissions. Global and regional organizations and governments have started to design and implement measures to reduce global greenhouse gas emissions in the healthcare sector, e.g. by green public procurement policies and inclusion of ecological considerations in the decision-making process for purchasing and funding of healthcare technologies. The objective of this study was to perform budget impact analysis of adopting RESPIMAT re-usable in the Nordics and Benelux that considered both the traditional healthcare costs as well as the environmental impact. Methods Inhaler costs and environmental impact over 5 years in the Nordics and Benelux in a scenario with RESPIMAT re-usable compared to a scenario without RESPIMAT re-usable were estimated using an budget impact model. RESPIMAT re-usable enables patients to re-use the inhaler device and its availability therefore reduces the number of inhalers and associated wastage. The carbon emissions were derived for each treatment pattern considering the whole life cycle (cradle-to-grave) of the inhaler product. The cost of carbon emissions was estimated using a societal cost per ton of carbon emission. Results Progressively introducing RESPIMAT re-usable in the Nordics and Benelux was estimated to decrease the number of inhalers used by 2023 by 7,466,621 compared to a scenario without RESPIMAT re-usable, which would result in a reduction of the environmental burden of inhaler use of 4717 tCO2e and a decrease in societal cost of €205,888. Conclusions Adopting RESPIMAT re-usable would lead to a substantial reduction in CO2 emissions, leading to savings from a societal perspective. Funding Boehringer Ingelheim. Electronic supplementary material The online version of this article (10.1007/s12325-019-01114-1) contains supplementary material, which is available to authorized users.

Tiotropium, a long-acting muscarinic antagonist, is approved for maintenance treatment of asthma in patients at least 6 years of age in the USA. We systematically reviewed published evidence on the efficacy and safety of 2.5 µg tiotropium Respimat® add-on therapy to inhaled corticosteroid (ICS) with or without additional controller medication(s) in children, adolescents, and adults with asthma. We searched PubMed from inception until October 3, 2018, for phase 2 and 3 randomized controlled trials (RCTs) evaluating the effects of 2.5 µg tiotropium Respimat® on lung function parameters in patients with asthma. We extracted adjusted mean differences for lung function data and adverse events (AEs) from relevant articles. Overall, 11 RCTs (three phase 2 and eight phase 3 studies) including 3244 patients (2.5 µg tiotropium Respimat®, n = 1642; placebo, n = 1602) met the predefined inclusion criteria. Once-daily 2.5 µg tiotropium Respimat® improved lung function parameters, including peak and trough forced expiratory volume in 1 s and peak and trough forced vital capacity, versus placebo. Overall, the safety profile of 2.5 µg tiotropium Respimat® was comparable to that of placebo, with the most commonly reported AEs being asthma worsening, reduction in peak expiratory rate, nasopharyngitis, and respiratory tract infections. On the basis of the results of phase 2 and 3 studies, 2.5 µg tiotropium Respimat® as add-on to ICS therapy was safe and associated with consistent improvements in lung function in patients with asthma of varying severities across different age groups. Development of the manuscript was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI).

Successful treatment for respiratory diseases relies on effective delivery of medication to the lungs using an inhalation device. Different inhalers have distinct characteristics affecting drug administration and patient adherence, which can impact clinical outcomes. We report on the development of the Respimat® soft mist inhaler (SMI) and compare key attributes with metered-dose inhalers (MDIs) and dry powder inhalers (DPIs). The Respimat SMI, a pocket-sized device generating a single-breath, inhalable aerosol, was designed to enhance drug delivery to the lungs, reduce the requirements for patient coordination and inspiratory effort, and improve the patients’ experience and ease of use. The drug deposition profile with Respimat SMI is favorable compared with MDIs and DPIs, with higher drug deposition to the lung and peripheral airways. The slow velocity and long spray duration of the Respimat SMI aerosol also aid patient coordination. Clinical equivalence has been demonstrated for maintenance treatment of chronic obstructive pulmonary disease using once-daily tiotropium between Respimat SMI (5 µg) and HandiHaler DPI (18 µg). In comparative studies, patients preferred Respimat SMI to MDIs and DPIs; they reported that Respimat SMI was easy to use and felt the inhaled dose was delivered. The Respimat SMI, designed to generate a slow-moving and fine mist, is easy to use and effectively delivers drug treatment to the lungs. The patient-centered design of Respimat SMI improved patient satisfaction, and may help to promote long-term adherence and improve clinical outcomes with asthma and chronic obstructive pulmonary disease.

Pressurised metered-dose inhalers (pMDIs) are associated with global warming potential values as they contain a hydrofluoroalkane (HFA) propellant, whereas the Respimat® Soft Mist™ inhaler is propellant-free. The original disposable Respimat has recently been updated to provide a reusable device that is similar in performance and use but is more convenient to patients and reduces environmental impact. This study compared the product carbon footprint (PCF) of Respimat (both disposable and reusable) and pMDIs to understand life cycle hotspots, and also to determine the potential quantitative environmental benefits of a reusable Respimat product. PCFs of four inhalation products—tiotropium bromide (Spiriva®) Respimat, ipratropium bromide/fenoterol hydrobromide (Berodual®) Respimat, Berodual HFA pMDI and ipratropium bromide (Atrovent®) HFA pMDI—were assessed across their whole life cycle. Data show that Respimat inhalers have a lower PCF (carbon dioxide equivalent per kilogram) than HFA pMDIs: pMDI Atrovent 14.59; pMDI Berodual 16.48; disposable Spiriva Respimat 0.78; disposable Berodual Respimat 0.78. Approximately 98% of the pMDI life cycle total is due to HFA propellant emissions during use and end-of-life phases. The impact of the material used for the Respimat product outweighs the impact of the material used to make the empty cartridge. Furthermore, compared with the single-use device over 1 month, the PCF of Spiriva Respimat was further reduced by 57% and 71% using the device with refill cartridges over 3 and 6 months, respectively. Together, these data suggest that Respimat inhalers, and in particular the new reusable inhaler, can reduce the environmental impact associated with inhaler use. Boehringer Ingelheim.

Background Patients with chronic obstructive pulmonary disease (COPD) show signs of reduced physical activity from the early stages of the disease, impacting morbidity and mortality. Data suggest treatment with tiotropium, a long-acting muscarinic antagonist, and olodaterol, a long-acting s2-agonist (LABA), as monotherapies and in combination, increases exercise capacity. This study assessed the effects of fixed-dose tiotropium/olodaterol (delivered via Respimat®) on physical function in Global Initiative for Chronic Obstructive Lung Disease A-D patients requiring long-acting dual bronchodilation treatment in a real-world setting. Methods This open-label, single arm, noninterventional study measured changes in physical function in COPD patients treated with tiotropium/olodaterol 5/5 μg for approximately 6 weeks (between Visit 1 [baseline] and Visit 2). Primary end point was therapeutic success, defined as a minimum 10-point increase in Physical Functioning Questionnaire (PF-10) score. Secondary end points included change in PF-10 from Visit 1 to Visit 2, the patient's general condition (measured by Physician's Global Evaluation score) at Visit 1 and Visit 2, and patient satisfaction with treatment delivered via the Respimat® device (assessed by Patient Satisfaction Questionnaire) at study end. Results Therapeutic success was observed in 51.5% of 1578 patients (95% confidence interval [CI] 49.0, 54.0) after approximately 6 weeks of treatment with tiotropium/olodaterol. Mean change in PF-10 score between Visit 1 and Visit 2 was 11.6 points (95% CI 10.7, 12.6). Patient general condition improved as indicated by a general improvement in scores between visits. Most patients were very satisfied or satisfied with tiotropium/olodaterol treatment (82.5%), inhalation (87.5%), and handling of Respimat® (85.2%). One percent of patients reported an investigator-defined drug-related adverse events (AE). Conclusion Tiotropium/olodaterol treatment improved physical functioning in COPD patients. An associated increase in patient general condition was observed. Most patients were very satisfied or satisfied with tiotropium/olodaterol treatment, inhaling, and handling of the Respimat® device. No unexpected drug-related AE occurred.

Background: Consumers are involved more than ever in their health care, with many utilizing the Internet for health information. YouTube is a convenient and vast source of health education videos. Pharmaceutical companies, health organizations, providers, and others post instructional videos for the use of the Respimat® Soft Mist™ Inhaler device on sites like YouTube. Therefore, review of content and quality is important to ensure consumers are directed to the best information available. Objective: Assess content and quality of YouTube videos demonstrating Respimat Soft Mist inhaler technique. Methods: YouTube was queried May 16, 2018 using the term “Respimat inhaler.” The first 35 unique videos in English with instructions for use were assessed. Technical quality of each video was evaluated using a validated scale and content assessed using manufacturer/package insert. Results: Of 35 videos reviewed, median duration was 2 minutes 50 seconds (interquartile range [IQR]: 1 minute 23 seconds-4 minutes 22 seconds). Target audience was laypeople for 97% (n = 34) of videos. The source was a professional organization for 70% (n = 24). Most (74%, n = 24) received the maximum quality score of 5. Commonly omitted steps included documentation of the discard date (74%), repetitive dose activation until spray is visible (49%), and pointing inhaler to the back of the throat (43%). Conclusions: Proper technique is crucial for patients to achieve optimal results from inhaled medications. While many videos are available through YouTube for demonstration of Respimat Soft Mist inhaler technique, some omitted key steps. Thorough and repetitive patient education should be provided, and augmented with reputable online sources.

Purpose The Respimat is a handheld, propellant-free, soft-mist inhaler. Observations by patients and physicians prompted development of an improved second-generation Respimat inhaler. Human-factor studies assessing the usability of the new inhaler and in vitro assessment of aerosol performance are important to demonstrate functionality of the updated inhaler. Methods Studies were performed to assess any possible impact of the reusable Respimat inhaler design on aerosol performance (delivered dose [DD] and fine-particle dose [FPD]) and iteratively assess and improve usability of the new design. The tiotropium-olodaterol inhalation solution for Respimat was used as a model. The DD and FPD of the reusable Respimat inhaler (across multiple cartridges) and the disposable Respimat inhaler were determined by laser diffraction and with an alternative Andersen cascade impactor. Usability was measured across three studies involving health care professionals and patients with diagnoses of COPD, asthma, or combined disease (with and without experience with the Respimat inhaler). These studies measured performance of handling tasks and collected subjective feedback directly related to the inhaler's new or altered features, which fed into optimization of the inhaler. Results DDs of tiotropium and olodaterol were stable up to 15 cartridges and consistently within the upper and lower limits of the disposable Respimat inhaler. The FPD was also found to be batch-consistent over the cartridges and comparable with the reference. The usability of the reusable Respimat inhaler compared with the disposable inhaler was improved in terms of assembly and daily use. Cartridge exchange was rated as intuitive and easy to very easy. Conclusion The new reusable Respimat is a medical inhaler developed with enhanced features that meets health care professionals' and patients' needs. Drug delivery across multiple cartridges is not affected by the design. Compared with the original disposable inhaler, the usability of the reusable inhaler has been improved, and cartridge exchange was rated as easy to perform. The reusable Respimat provides greater convenience for patients vs the disposable inhaler, with reduced environmental impact.

BACKGROUND: Despite currently available therapies and detailed treatment guidelines, many patients with asthma remain symptomatic. Tiotropium delivered by the soft mist inhaler Respimat®, as add-on therapy to medium-dose inhaled corticosteroids (ICS), has been shown to improve lung function and asthma control in patients with symptomatic moderate asthma.OBJECTIVE: To determine whether the efficacy of tiotropium Respimat® in asthma differs by patients' study baseline characteristics.METHODS: Two replicate Phase III, randomized, double-blind, placebo-controlled, parallel-group studies (MezzoTinA-asthma®; NCT01172808 and NCT01172821) of once-daily tiotropium Respimat 5 μg and 2.5 μg add-on to ICS were conducted in patients with symptomatic asthma despite treatment with medium-dose ICS with or without additional controllers. Subgroup analyses of peak forced expiratory volume in 1 s (FEV1), trough FEV1, risk of severe asthma exacerbation and Asthma Control Questionnaire responder rate were performed to determine whether results were influenced by patients' baseline characteristics.RESULTS: In this analysis, 523 patients received placebo while 517 and 519 patients received the 5 μg and 2.5 μg dose of tiotropium Respimat, respectively. The magnitude of the improvements in lung function and asthma control, as well as the reduced risk of severe exacerbation with both doses of tiotropium Respimat versus placebo, was independent of a broad range of baseline characteristics.CONCLUSIONS: Once-daily tiotropium Respimat as add-on to ICS is a beneficial treatment option for patients with asthma who remain symptomatic despite at least medium-dose ICS, regardless of baseline characteristics.

Jong Geol Jang, Jin Hong Chung, Kyeong-Cheol Shin, Hyun Jung Jin, Kwan Ho Lee, June Hong Ahn Department of Internal Medicine, Division of Pulmonology and Allergy, College of Medicine, Yeungnam University and Regional Center for Respiratory Diseases, Yeungnam University Medical Center, Daegu, Republic of KoreaCorrespondence: Kwan Ho Lee; June Hong AhnDepartment of Internal Medicine, Division of Pulmonology and Allergy, College of Medicine, Yeungnam University and Regional Center for Respiratory Diseases, Yeungnam University Medical Center, 170 Hyeonchung-ro, Namgu, Daegu, 42415, Republic of KoreaTel +82-53-640-6601; +82-53-640-6577Fax +82-53-620-3849Email ghlee@med.yu.ac.kr; fireajh@gmail.comObjective: Critical inhaler handling errors are associated with an increased risk of adverse outcomes in patients with chronic obstructive pulmonary disease (COPD). However, real-world data on inhaler device handling techniques and the risk factors for critical inhaler errors in the Asian population have been examined in only a few studies. We evaluated the rates and risk factors for critical inhaler errors in the COPD population in Korea.Methods: COPD patients were prospectively enrolled from January 2018 to November 2019. An advanced practice nurse evaluated their inhaler technique. The 308 inhalers used by the 261 participants in this study included dry powder inhalers (DPIs; Turbuhaler, Breezhaler, Ellipta, Diskus, Genuair), a soft mist inhaler (SMI; Respimat), and pressurized metered dose inhalers (pMDIs).Results: The percentage critical errors for Turbuhaler, Breezhaler, Ellipta, Diskus, Genuair, Respimat, and pMDI usage were 60.0%, 41.0%, 27.8%, 12.5%, 44.4%, 45.5%, and 55.0%, respectively. In the multivariate analyses, female sex, short COPD duration, dissatisfaction with the inhaler (assessed by FSI-10), and moderate acute exacerbations (AEs) in the prior year were independent risk factors for any critical error in the DPI group. In the SMI group, a low education level and frequent AEs in the prior year were independent risk factors for any critical error, whereas a high COPD assessment test (CAT) score was the only risk factor in the pMDI group.Conclusion: Critical inhaler errors are common among patients with COPD, regardless of their preferred inhaler device. The rates and risk factors for critical inhaler errors differed among patients using different devices. Optimal device selection considering the risk factors of inhaler misusage will improve disease control in COPD patients.Keywords: COPD, inhalation therapy, error, risk factor

AIMS There is a lack of an overview of determinants of incorrect inhaler technique among chronic obstructive pulmonary diseases (COPD) subjects. The aim of this study was to determine the prevalence and possible determinants of incorrect inhaler technique in COPD subjects with common inhalers. METHODS A cross over study was conducted in 180 COPD subjects. Baseline assessment of inhaler technique was evaluated in 10 placebo inhalers including: [pressurised metered dose inhaler (pMDI), Aerolizer, Handihaler, Turbohaler, Discus, Breezhaler, Ellipta, Easyhaler, Diskhaler and Respimat] without receiving any instructions. Subjects were then crossed over to other inhalers in random order. Inhaler technique was assessed. The proper technique of inhalers was demonstrated and the number of counselling attempts needed to achieve a correct technique was recorded. Patient past-experience, demographics/clinical variables were recorded. RESULTS Incorrect inhaler techniques were highly prevalent among COPD subjects, ranging from 80% of participants demonstrated incorrect use, a minimum of 1 error, with Ellipta, to 100% with Respimat/Diskhaler (P

The Respimat® Soft Mist™ inhaler (SMI) has recently been improved, with a re-usable device replacing the disposable version. Certain countries are currently phasing out the disposable inhaler. This study aimed to assess patient satisfaction with and preference for the re-usable device. This 4–6-week, multicentre, open-label, prospective, real-world, non-interventional study was conducted across six European countries. Patients with chronic obstructive pulmonary disease were enrolled between October and December 2019, in three cohorts: (1) currently using the re-usable Respimat SMI; (2) switched from disposable Respimat SMI at study entry; and (3) naïve to any Respimat SMI. Patients were assessed using the Patient Satisfaction and Preference Questionnaire (PASAPQ) and Ease of Handling Questionnaire. In total, 262 patients were enrolled. At follow-up, the mean PASAPQ score was 83.3/100 overall, with similar results across all three patient cohorts. Most patients were ‘satisfied’ or ‘very satisfied’ with the re-usable device. The overall score for willingness to continue using the device was 87.8/100. In total, 13 adverse events were recorded, none of which was classified as serious. This study provides real-world evidence for practitioners to start patients on Respimat re-usable, irrespective of a patient’s prior experience with this inhaler. Plain language summary: Inhalers are often used to treat patients with chronic obstructive pulmonary disease (COPD). However, there are many available, which can lead to confusion and poor inhaler technique. It is important for a patient to be happy with their inhaler. This study looked at how patients liked the re-usable Respimat® Soft Mist™ inhaler vs. their previous inhaler. It also asked whether they would be willing to continue using the device at the end of the study period.After 4–6 weeks of using the re-usable device, patients reported that they were happy with the inhaler and most would be willing to carry on using it.Overall, these results show that doctors can prescribe Respimat re-usable to patients, even if the patient has not used the inhaler before.

Dry powder inhalers (DPIs) have about 20-fold lower carbon footprint (CO2FP) than metered dose inhalers (MDIs) with estimates of CO2FP between 1.5 and 6 kg CO2e for a 200-dose DPI. GSK’s Carbon Trust-verified analysis including Relvar and Seretide Accuhaler is about 1 kg CO2e/inhaler, and Product Carbon Footprint analysis of Spiriva Respimat 0.780 kg CO2e. Still, limited data is available on CO2FP and Life Cycle Assessment (LCA) of different types of DPIs. We conducted a Cradle-to-Grave (CTG) CO2FP analysis and LCA of four different Easyhaler® (EH) products available for the treatment of asthma and COPD (budesonide-formoterol; salmeterol-fluticasone; salbutamol, and formoterol EH). In-depth data collection from Orion in-house data, suppliers, and reference databases was conducted in 2019. Analyses were performed by ISO14001:2015 and 9001:2015 certified Carbon Footprint Ltd. The total CTG life cycle emissions for one EH (average) was 0.588 kg CO2e (range 0.514–0.664 kg). Emissions from manufacture accounted for 60% (range 54–65%). In comparison, emissions from distribution accounted for less than 2%, indicating that most potential for improvement lies in manufacture processes. Patients with asthma or COPD, and treating physicians alike, are increasingly aware of climate change and this affects even their treatment choices. When considering the climate impact of inhalation therapy, DPIs, like EH, have a minimal carbon footprint compared with MDI.

Chronic respiratory disease 18, (2021). doi:10.1177/1479973120986228, Published by Sage, London

ObjectivesThe large number of available medicines and devices makes it almost impossible to have sufficient knowledge of each individual medicine and device, especially for general practitioners. This may lead to suboptimal treatment, more exacerbations, hospitalisations and higher treatment costs. Reducing the number of medicines and devices, based on rational criteria, allows physicians and pharmacists to build experience with a more limited set of medicines and to standardise the inhalation instructions.MethodsIn this study inhalers are compared by means of the System of Objectified Judgement Analysis (SOJA) method. The following selection criteria were applied: uniformity in device, number of steps per inhalation, risk of errors, hygienic aspects, feedback mechanism, and risk of inhalation with an empty inhaler.ResultsSubstantial differences were seen in the overall scores, with the Ellipta device showing the highest score, followed by Diskus/Accuhaler, Genuair and Nexthaler. Several devices require more or less identical techniques, such Ellipta and Diskus/Accuhaler as well as Genuair and Novolizer. When patients use these devices in combination this increases their uniformity, because additional medicines become available for the devices: starting therapy with Diskus or Novolizer and follow-up with Ellipta or Genuair. The resistance of Respimat and Breezhaler is lower than that of other devices, which makes these devices suitable for patients who cannot generate sufficient inhalation flow.ConclusionsA substantial reduction of inhalers, combined with optimal and standardised instructions, should improve the care of patients with chronic obstructive pulmonary disease.