Back to Journals » International Journal of Chronic Obstructive Pulmonary Disease » Volume 14

Assessment of physical functioning and handling of tiotropium/olodaterol Respimat® in patients with COPD in a real-world clinical setting

Authors Steinmetz KO, Abenhardt B, Pabst S, Hänsel M, Kondla A, Bayer V, Buhl R

Received 24 November 2018

Accepted for publication 17 May 2019

Published 4 July 2019 Volume 2019:14 Pages 1441—1453


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Dr Richard Russell

Karl-Otto Steinmetz,1 Birgit Abenhardt,2 Stefan Pabst,3 Michaela Hänsel,4 Anke Kondla,5 Valentina Bayer,6 Roland Buhl7

1LungCenter 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, Germany

Background: 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

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. 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. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]