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Karl-Otto Steinmetz,1 Birgit Abenhardt,2 Stefan Pabst,3 Michaela Hänsel,4 Anke Kondla,5 Valentina Bayer,6 Roland Buhl71LungCenter Darmstadt, Darmstadt, Germany; 2Pulmonary Practice, Heidelberg, Germany; 3Lung Center, Bonn-Duisdorf, Germany; 4TA Respiratory/Biosimilars, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 5Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 6Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 7Pulmonary Department, Johannes Gutenberg University Hospital Mainz, Mainz, GermanyBackground: 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 ß2-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.Keywords: tiotropium, olodaterol, chronic obstructive pulmonary disease, physical activity, noninterventional study |
