BI 1744 CL With Respimat Once Daily Versus Twice Daily in COPD

Phase 2 Completed 47 enrolled Boehringer Ingelheim

CrossoverTreatment

Summary

The primary objective of the trial is to determine the effect of BI 17444Cl on the lung function over a 24-hour period, when it is inhaled using the Respimat inhaler in patients with chronic obstructive pulmonary disease. In the trial four treatments of each 3 weeks of duration are included: 2 dosages in a once daily administration and 2 dosages for administration twice daily.

Timeline

Start: 2009-02
Primary completion: 2009-07
Completion: —

Outcome

Mixed primary results

registry analysis (superiority or other test); Olo 2 mcg Bid vs Olo 5 mcg qd; p = 0.0003; Mean Difference (Final Values) 0.054 (95% CI 0.025 to 0.083); Mixed Models Analysis NCT00846768 ↗

registry analysis (superiority or other test); Olo 2 mcg Bid vs Olo 5 mcg qd; p = 0.4111; Mean Difference (Final Values) -0.012 (95% CI -0.041 to 0.017); Mixed Models Analysis NCT00846768 ↗

Publications

Joos GF, Aumann JL, Coeck C, Korducki L, Hamilton AL, Kunz C, Aalbers R. A randomised, double-blind, four-way, crossover trial comparing the 24-h FEV1 profile for once-daily versus twice-daily treatment with olodaterol, a novel long-acting beta2-agonist, in patients with chronic obstructive pulmonary disease. Respir Med. 2015 May;109(5):606-15. doi: 10.1016/j.rmed.2015.02.005. Epub 2015 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olodaterol	Small molecule	2 ug	Inhaled
Subject	Olodaterol	Small molecule	5 ug	Inhaled
Subject	Olodaterol	Small molecule	10 ug	Inhaled