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      Improving usability and maintaining performance: human-factor and aerosol-performance studies evaluating the new reusable Respimat inhaler

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          Abstract

          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.

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          Most cited references 16

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          Adherence to inhaled therapies, health outcomes and costs in patients with asthma and COPD.

          Suboptimal adherence to pharmacological treatment of asthma and chronic obstructive pulmonary disease (COPD) has adverse effects on disease control and treatment costs. The reasons behind non-adherence revolve around patient knowledge/education, inhaler device convenience and satisfaction, age, adverse effects and medication costs. Age is of particular concern given the increasing prevalence of asthma in the young and increased rates of non-adherence in adolescents compared with children and adults. The correlation between adherence to inhaled pharmacological therapies for asthma and COPD and clinical efficacy is positive, with improved symptom control and lung function shown in most studies of adults, adolescents and children. Satisfaction with inhaler devices is also positively correlated with improved adherence and clinical outcomes, and reduced costs. Reductions in healthcare utilisation are consistently observed with good adherence; however, costs associated with general healthcare and lost productivity tend to be offset only in more adherent patients with severe disease, versus those with milder forms of asthma or COPD. Non-adherence is associated with higher healthcare utilisation and costs, and reductions in health-related quality of life, and remains problematic on an individual, societal and economic level. Further development of measures to improve adherence is needed to fully address these issues. Copyright © 2013. Published by Elsevier Ltd.
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            Impact of patients' satisfaction with their inhalers on treatment compliance and health status in COPD.

            To examine the relationships between inhaler satisfaction, treatment compliance and health status in patients with chronic obstructive pulmonary disease (COPD). In a large, multinational, cross-sectional, real-world survey, respiratory specialists and primary care physicians provided information on six consecutive patients with COPD, who were then asked to complete a questionnaire. Physician-assessed compliance was scored (5-point Likert scale) and patients rated overall satisfaction with their maintenance inhaler (7-point Likert scale). Health status assessments included frequency of exacerbations and hospitalizations due to exacerbations in the past 12 months. The analysis included 1443 patients (71.8% male; mean age 65.2 years). Patients' overall satisfaction with their inhaler was significantly associated with treatment compliance (χ(2) - df = 89.7; p < 0.001). Male gender (χ(2) - df = 2.9; p < 0.05) and fewer maintenance drugs (χ(2) - df = 17.7; p < 0.001) were also associated with compliance; age and breathlessness severity were not. Attributes influencing inhaler satisfaction mainly related to durability, ergonomics and ease of use. Small but statistically significant associations were observed between increasing treatment compliance and fewer exacerbations (R(2) = 0.037; p < 0.001) and fewer hospitalizations due to exacerbations (R(2) = 0.025; p < 0.001). There was a direct association between inhaler satisfaction and fewer exacerbations (R(2) = 0.03; p < 0.001). Treatment compliance appears to be modestly associated with inhaler satisfaction, better health status and less frequent COPD exacerbations, although other factors are also likely to be involved. Durability, ergonomics and ease-of-use are inhaler attributes that influence patient satisfaction. Copyright © 2013 Elsevier Ltd. All rights reserved.
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              Patient preferences for inhaler devices in chronic obstructive pulmonary disease: experience with Respimat® Soft Mist™ Inhaler

              Current guidelines for the management of chronic obstructive pulmonary disease (COPD) recommend the regular use of inhaled bronchodilator therapy in order to relieve symptoms and prevent exacerbations. A variety of inhaler devices are currently available to COPD patients, and the choice of device is an important consideration because it can influence patients’ adherence to treatment, and thus potentially affect the long-term outcome. The Respimat® Soft Mist™ Inhaler (SMI) generates a slow-moving aerosol with a high fine particle fraction, resulting in deposition of a higher proportion of the dose in the lungs than pressurized metered-dose inhalers (pMDIs) or some dry powder inhalers (DPIs). We review clinical studies of inhaler satisfaction and preference comparing Respimat® SMI against other inhalers in COPD patients. Using objective and validated patient satisfaction instruments, Respimat® SMI was consistently shown to be well accepted by COPD patients, largely due to its inhalation and handling characteristics. In comparative studies with pMDIs, the patient total satisfaction score with Respimat® SMI was statistically and clinically significantly higher than with the pMDI. In comparative studies with DPIs, the total satisfaction score was statistically significantly higher than for the Turbuhaler® DPI, but only the performance domain of satisfaction was clinically significantly higher for Respimat® SMI. Whether the observed higher levels of patient satisfaction reported with Respimat® SMI might be expected to result in improved adherence to therapy and thus provide benefits consistent with those recently shown to be associated with sustained bronchodilator treatment in patients with COPD remains to be proven.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2019
                05 March 2019
                : 14
                : 509-523
                Affiliations
                [1 ]Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN 37920, USA
                [2 ]Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein 55216, Germany, herbert.wachtel@ 123456boehringer-ingelheim.com
                [3 ]Boehringer Ingelheim International GmbH, Ingelheim am Rhein 55216, Germany
                [4 ]Boehringer Ingelheim Pharma, Biberach an der Riss 88397, Germany
                Author notes
                Correspondence: Herbert Wachtel, Boehringer Ingelheim Pharma GmbH & Co. KG, 173 Binger Strasse, Ingelheim am Rhein 55216, Germany, Tel +49 613 2779 8552, Email herbert.wachtel@ 123456boehringer-ingelheim.com
                Article
                copd-14-509
                10.2147/COPD.S190639
                6407979
                © 2019 Dhand et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Original Research

                Respiratory medicine

                environment, inhalers, handling, smi, soft mist

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