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

Phase 3 Completed 99 enrolled Boehringer Ingelheim

RandomizedCrossoverDouble-blindTreatment

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: 2009-06
Primary completion: 2010-04
Completion: —

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Olo 5 mcg qd; p <0.0001; Mean Difference (Final Values) 0.148 (95% CI 0.113 to 0.183); Mixed Models Analysis NCT00931385 ↗

registry analysis (superiority or other test); Placebo vs Olo 5 mcg qd; p <0.0001; Mean Difference (Final Values) 0.109 (95% CI 0.073 to 0.146); Mixed Models Analysis NCT00931385 ↗

Publications

Feldman GJ, Bernstein JA, Hamilton A, Nivens MC, Korducki L, LaForce C. The 24-h FEV1 time profile of olodaterol once daily via Respimat(R) and formoterol twice daily via Aerolizer(R) in patients with GOLD 2-4 COPD: results from two 6-week crossover studies. Springerplus. 2014 Aug 9;3:419. doi: 10.1186/2193-1801-3-419. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Formoterol	Other / unclassified	12 ug	Inhaled
Subject	Olodaterol	Small molecule	5 ug	Inhaled
Subject	Olodaterol	Small molecule	10 ug	Inhaled