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      Assessment of Patient Experiences with Respimat ® in Everyday Clinical Practice

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          Abstract

          Introduction

          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 β 2-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).

          Methods

          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.

          Results

          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.

          Conclusion

          In this study, over 9000 patients reported satisfaction with respect to inhalation and handling of the Respimat SMI, and patient adherence was high.

          Trial registration

          ClinicalTrials.gov: NCT02675517 (SPIRIT) and NCT02719639 (OTIVACTO).

          Plain Language Summary

          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.

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          Most cited references30

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          A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease.

          Currently available inhaled bronchodilators used as therapy for chronic obstructive pulmonary disease (COPD) necessitate multiple daily dosing. The present study evaluates the long-term safety and efficacy of tiotropium, a new once-daily anticholinergic in COPD. Patients with stable COPD (age 65.2+/-8.7 yrs (mean+/-SD), n=921) were enrolled in two identical randomized double-blind placebo-controlled 1-yr studies. Patients inhaled tiotropium 18 microg or placebo (mean screening forced expiratory volume in one second (FEV1) 1.01 versus 0.99 L, 39.1 and 38.1% of the predicted value) once daily as a dry powder. The primary spirometric outcome was trough FEV1 (i.e. FEV1 prior to dosing). Changes in dyspnoea were measured using the Transition Dyspnea Index, and health status with the disease-specific St. George's Respiratory Questionnaire and the generic Short Form 36. Medication use and adverse events were recorded. Tiotropium provided significantly superior bronchodilation relative to placebo for trough FEV1 response (approximately 12% over baseline) (p<0.01) and mean response during the 3 h following dosing (approximately 22% over baseline) (p<0.001) over the 12-month period. Tiotropium recipients showed less dyspnoea (p<0.001), superior health status scores, and fewer COPD exacerbations and hospitalizations (p<0.05). Adverse events were comparable with placebo, except for dry mouth incidence (tiotropium 16.0% versus placebo 2.7%, p<0.05). Tiotropium is an effective, once-daily bronchodilator that reduces dyspnoea and chronic obstructive pulmonary disease exacerbation frequency and improves health status. This suggests that tiotropium will make an important contribution to chronic obstructive pulmonary disease therapy.
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            Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline

            Background: This document provides clinical recommendations for the pharmacologic treatment of chronic obstructive pulmonary disease (COPD). It represents a collaborative effort on the part of a panel of expert COPD clinicians and researchers along with a team of methodologists under the guidance of the American Thoracic Society. Methods: Comprehensive evidence syntheses were performed on all relevant studies that addressed the clinical questions and critical patient-centered outcomes agreed upon by the panel of experts. The evidence was appraised, rated, and graded, and recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Results: After weighing the quality of evidence and balancing the desirable and undesirable effects, the guideline panel made the following recommendations: 1) a strong recommendation for the use of long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) combination therapy over LABA or LAMA monotherapy in patients with COPD and dyspnea or exercise intolerance; 2) a conditional recommendation for the use of triple therapy with inhaled corticosteroids (ICS)/LABA/LAMA over dual therapy with LABA/LAMA in patients with COPD and dyspnea or exercise intolerance who have experienced one or more exacerbations in the past year; 3) a conditional recommendation for ICS withdrawal for patients with COPD receiving triple therapy (ICS/LABA/LAMA) if the patient has had no exacerbations in the past year; 4) no recommendation for or against ICS as an additive therapy to long-acting bronchodilators in patients with COPD and blood eosinophilia, except for those patients with a history of one or more exacerbations in the past year requiring antibiotics or oral steroids or hospitalization, for whom ICS is conditionally recommended as an additive therapy; 5) a conditional recommendation against the use of maintenance oral corticosteroids in patients with COPD and a history of severe and frequent exacerbations; and 6) a conditional recommendation for opioid-based therapy in patients with COPD who experience advanced refractory dyspnea despite otherwise optimal therapy. Conclusions: The task force made recommendations regarding the pharmacologic treatment of COPD based on currently available evidence. Additional research in populations that are underrepresented in clinical trials is needed, including studies in patients with COPD 80 years of age and older, those with multiple chronic health conditions, and those with a codiagnosis of COPD and asthma.
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              Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes

              Background Inhaled drug delivery is the cornerstone treatment for asthma and chronic obstructive pulmonary disease (COPD). However, use of inhaler devices can be challenging, potentially leading to critical errors in handling that can significantly reduce drug delivery to the lungs and effectiveness of treatment. Methods A systematic review was conducted to define ‘critical’ errors and their impact on health outcomes and resource use between 2004 and 2016, using key search terms for inhaler errors in asthma and COPD (Search-1) and associated health-economic and patient burden (Search-2). Results Search-1 identified 62 manuscripts, 47 abstracts, and 5 conference proceedings (n = 114 total). Search-2 identified 9 studies. We observed 299 descriptions of critical error. Age, education status, previous inhaler instruction, comorbidities and socioeconomic status were associated with worse handling error frequency. A significant association was found between inhaler errors and poor disease outcomes (exacerbations), and greater health-economic burden. Conclusions We have shown wide variations in how critical errors are defined, and the evidence shows an important association between inhaler errors and worsened health outcomes. Given the negative impact diminished disease outcomes impose on resource use, our findings highlight the importance of achieving optimal inhaler technique, and a need for a consensus on defining critical and non-critical errors. Electronic supplementary material The online version of this article (10.1186/s12931-017-0710-y) contains supplementary material, which is available to authorized users.
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                Author and article information

                Contributors
                christian.taube@rlk.uk-essen.de
                Journal
                Pulm Ther
                Pulm Ther
                Pulmonary Therapy
                Springer Healthcare (Cheshire )
                2364-1754
                2364-1746
                28 August 2020
                28 August 2020
                December 2020
                : 6
                : 2
                : 371-380
                Affiliations
                [1 ]GRID grid.410718.b, ISNI 0000 0001 0262 7331, University Hospital Essen-Ruhrlandklinik, ; Essen, Germany
                [2 ]GRID grid.418412.a, ISNI 0000 0001 1312 9717, Boehringer Ingelheim Pharmaceuticals, Inc., ; Ridgefield, CT USA
                [3 ]GRID grid.420061.1, ISNI 0000 0001 2171 7500, Boehringer Ingelheim Pharma GmbH & Co. KG, ; Ingelheim am Rhein, Germany
                [4 ]Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria
                Article
                127
                10.1007/s41030-020-00127-4
                7671953
                32857327
                db28023a-f63c-40c0-b35a-7f68eabbc314
                © The Author(s) 2020
                History
                : 29 June 2020
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100008349, Boehringer Ingelheim;
                Categories
                Brief Report
                Custom metadata
                © The Author(s) 2020

                bronchodilator,copd,inhaler,non-interventional studies,observational patient satisfaction,otivacto,soft mist,spirit

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