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

Phase 3 Completed 157 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 Placebo vs Olo 5 mcg qd; p = 0.0018; Ratio to placebo 1.118 (95% CI 1.043 to 1.199) NCT01040793 ↗

registry Placebo vs Olo 10 mcg qd; p = 0.0052; Ratio to placebo 1.105 (95% CI 1.030 to 1.184) NCT01040793 ↗

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