Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanese Patients With COPD

Phase 2 Completed 328 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.

Timeline

Start: 2009-01
Primary completion: 2010-03
Completion: —

Outcome

Met primary endpoint

paper All olodaterol doses assessed in the study showed statistically significant increases in trough FEV1 compared to placebo at Day 29 (P<0.0001). PMID 26316741 ↗

registry Placebo vs Olodaterol 2mcg; p <0.0001; Least Squares Mean for the difference 0.091 (95% CI 0.051 to 0.131); ANCOVA NCT00824382 ↗

Publications

Ichinose M, Takizawa A, Izumoto T, Tadayasu Y, Hamilton AL, Kunz C, Fukuchi Y. Efficacy and safety of the long-acting beta2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015 Aug 20;10:1673-83. doi: 10.2147/COPD.S86002. eCollection 2015.

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