Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.

Phase 3 Completed 291 enrolled Boehringer Ingelheim

RandomizedCrossoverDouble-blindTreatment

Summary

The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD.

Timeline

Start: 2012-02
Primary completion: 2013-11
Completion: 2013-11

Outcome

Mixed primary results

registry Placebo vs Tiotropium + Olodaterol 5/5; p <0.0001; Mean Difference (Final Values) 0.265 (95% CI 0.215 to 0.315); Mixed Models Analysis NCT01533935 ↗

registry Placebo vs Tiotropium + Olodaterol 5/5; p <0.0001; Ratio 1.134 (95% CI 1.065 to 1.206); Mixed Models Analysis NCT01533935 ↗

registry Tiotropium 5 µg vs Tiotropium + Olodaterol 5/5; p = 0.1807; Ratio 1.043 (95% CI 0.981 to 1.109); Mixed Models Analysis NCT01533935 ↗

Publications

O'Donnell DE, Casaburi R, Frith P, Kirsten A, De Sousa D, Hamilton A, Xue W, Maltais F. Effects of combined tiotropium/olodaterol on inspiratory capacity and exercise endurance in COPD. Eur Respir J. 2017 Apr 19;49(4):1601348. doi: 10.1183/13993003.01348-2016. Print 2017 Apr.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Olodaterol	Small molecule	5 ug	Inhaled
Subject	Tiotropium	Other / unclassified	2.5 ug	Inhaled
Subject	Tiotropium	Other / unclassified	5 ug	Inhaled