BACKGROUND: Reduced physical activity is associated with increased morbidity and mortality in patients with COPD. Studies suggest that treatment with the long-acting muscarinic antagonist tiotropium and the long-acting β2-agonist olodaterol increases exercise capacity. This study assessed the effects of a fixed-dose combination (FDC) of tiotropium/olodaterol (delivered via Respimat®) on physical functioning in patients with stable COPD in a "real-world setting". METHODS: An international, open-label, single-arm, non-interventional study conducted in nine countries measuring changes in self-reported physical functioning in COPD patients treated with tiotropium/olodaterol 5/5 μg FDC for approximately 6 weeks. The primary endpoint was therapeutic success, defined as a minimum 10-point increase in the 10-question Physical Functioning Questionnaire (PF-10) score. Secondary endpoints included absolute change in PF-10 from Visit 1 to Visit 2, patient general condition (measured by Physician's Global Evaluation score) and patient satisfaction with the treatment and device (assessed by Patient Satisfaction Questionnaire at the end of the study period). RESULTS: Therapeutic success was observed in 67.8% of 7218 patients (95% CI 66.7, 68.8) in the final analysis set after approximately 6 weeks of treatment with tiotropium/olodaterol. Mean change in PF-10 score between Visit 1 and Visit 2 was 16.6 points (95% CI 16.2, 17.0). Therapeutic success was 64.3% (95% CI 63.0-65.6%) in patients with infrequent (≤1) and 76.1% (95% CI 74.3-77.9%) in patients with frequent (≥2) exacerbations (p<0.0001). Patient general condition improved as indicated by an improvement in Physician's Global Evaluation scores between visits. Most patients were very satisfied or satisfied with tiotropium/olodaterol treatment in general (81%), reported inhalation satisfaction (85%), and satisfactory handling of the device (84%). 1.3% of patients reported an investigator-defined drug-related adverse event. CONCLUSION: Treatment with tiotropium/olodaterol led to an improvement in self-reported physical functioning in patients with COPD.

Biostatistics and Data Sciences Boehringer Ingelheim Pharmaceuticals Inc Ridgefield CT USA

Department of Functional Diagnostics Specialized Hospital of Saint Zoerardus Teaching Facility of the Slovak Medical University Nitra Slovakia

Department of Internal Medicine Hebrew University Hadassah Medical School Jerusalem Israel

Department Of Pneumology Carol Davila University of Medicine and Pharmacy Bucharest Romania

Department of Pneumology Institute of Pneumatology Marius Nasta Bucharest Romania

Department of Pulmonology Pirogov Russian National Research Medical University Pletnev Hospital Moscow Russian Federation

Department of Respiratory and Critical Care Medicine Karl Landsteiner Institute for Lung Research and Pulmonary Oncology Krankenhaus Nord Klinik Floridsdorf Vienna Austria

Elizabeth Nursing Home Gödöllő Hungary

Lung Centre Pneumology Department University Hospital Basel Basel Switzerland

Medical Affairs Regional Center Boehringer Ingelheim RCV GmbH and Co KG Vienna Austria

Pneumological Outpatient Department MephaCentrum a s Ostrava Poruba Czech Republic

Respiratory TA Boehringer Ingelheim RCV GmbH and Co KG Vienna Austria

Topolšica Hospital Topolšica Slovenia

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Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study