Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease

Summary

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Timeline

Start

2010-01

Primary completion

2011-01

Completion

—

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Olo 5 mcg qd; p <0.0001; Mean Difference (Final Values) 0.185 (95% CI 0.145 to 0.224); Mixed Models Analysis NCT01040689 ↗

registry analysis (superiority or other test); Placebo vs Olo 5 mcg qd; p <0.0001; Mean Difference (Final Values) 0.131 (95% CI 0.090 to 0.173); Mixed Models Analysis NCT01040689 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olodaterol	Small molecule	5 ug	Inhaled
Subject	Olodaterol	Small molecule	10 ug	Inhaled
Comparator	Tiotropium	Other / unclassified	18 ug	Inhaled

Indications