Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I

Phase 3 Completed 151 enrolled Boehringer Ingelheim

RandomizedCrossoverDouble-blindTreatment

Summary

To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease

Timeline

Start: 2010-01
Primary completion: 2011-04
Completion: —

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Olo 5 mcg qd; p = 0.0002; Ratio to placebo 1.140 (95% CI 1.065 to 1.221); Mixed Models Analysis NCT01040130 ↗

registry analysis (superiority or other test); Placebo vs Olo 10 mcg qd; p = 0.0003; Ratio to placebo 1.138 (95% CI 1.062 to 1.219); Mixed Models Analysis NCT01040130 ↗

Publications

Maltais F, Kirsten AM, Hamilton A, De Sousa D, Voss F, Decramer M. Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies. Respir Res. 2016 Jul 6;17(1):77. doi: 10.1186/s12931-016-0389-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olodaterol	Small molecule	5 ug	Inhaled
Subject	Olodaterol	Small molecule	10 ug	Inhaled