Improvement In Self-Reported Physical Functioning With Tiotropium/Olodaterol In Central And Eastern European COPD Patients

Abstract

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 β ₂-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.

Journal

Journal ID (nlm-ta): Int J Chron Obstruct Pulmon Dis

Journal ID (iso-abbrev): Int J Chron Obstruct Pulmon Dis

Journal ID (publisher-id): COPD

Journal ID (pmc): copd

Title: International Journal of Chronic Obstructive Pulmonary Disease

Publisher: Dove

ISSN (Print): 1176-9106

ISSN (Electronic): 1178-2005

Publication date (Electronic): 11 October 2019

Publication date Collection: 2019

Volume: 14

Pages: 2343-2354

Affiliations

[1 ]Department of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology , Krankenhaus Nord – Klinik Floridsdorf, Vienna, Austria

[2 ]Lung Centre/Pneumology Department, University Hospital Basel , Basel, Switzerland

[3 ]Pneumological Outpatient Department, MephaCentrum, a.s ., Ostrava-Poruba, Czech Republic

[4 ]Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc ., Ridgefield, CT, USA

[5 ]Respiratory TA, Boehringer Ingelheim RCV GmbH & Co. KG , Vienna, Austria

[6 ]Medical Affairs Regional Center, Boehringer Ingelheim RCV GmbH & Co. KG , Vienna, Austria

[7 ]Elizabeth Nursing Home , Gödöllő, Hungary

[8 ]Department of Internal Medicine, Hebrew University Hadassah Medical School , Jerusalem, Israel

[9 ]Department of Pneumology, Institute of Pneumatology “Marius Nasta” , Bucharest, Romania

[10 ]Department Of Pneumology, Carol Davila University of Medicine and Pharmacy , Bucharest, Romania

[11 ]Department of Pulmonology, Pirogov Russian National Research Medical University, Pletnev Hospital , Moscow, Russian Federation

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

[13 ]Topolšica Hospital , Topolšica, Slovenia

Author notes

Correspondence: Arschang Valipour Department of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology , Krankenhaus Nord-Klinik, Floridsdorf Brünnerstrasse 68, Wien, Vienna1210, AustriaTel [phone] Email [e-mail]

Article

Publisher ID: 204388

DOI: 10.2147/COPD.S204388

PMC ID: 6793952

Copyright statement: © 2019 Valipour et al.

License:

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Page count

Figures: 3, Tables: 4, References: 68, Pages: 12

Categories

Subject: Clinical Trial Report