Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

Phase 2 Completed 233 enrolled Boehringer Ingelheim

RandomizedCrossoverDouble-blindTreatment

Summary

The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.

Timeline

Start: 2010-01
Primary completion: 2011-02
Completion: —

Outcome

Met primary endpoint

paper Addition of tiotropium 1.25, 2.5, and 5 µg to olodaterol 5 µg increased mean trough FEV1 response by 0.054, 0.065, and 0.084 L, respectively; PMID 26404912 ↗

registry analysis (superiority or other test); Olo 5 vs T+O 1.25/5; Mean Difference (Final Values) 0.054 (95% CI 0.016 to 0.092); Mixed Models Analysis NCT01040403 ↗

registry analysis (superiority or other test); Olo 10 vs T+O 2.5/10; Mean Difference (Final Values) 0.083 (95% CI 0.045 to 0.122); Mixed Models Analysis NCT01040403 ↗

Publications

Aalbers R, Maleki-Yazdi MR, Hamilton A, Waitere-Wijker S, Zhao Y, Amatto VC, Schmidt O, Bjermer L. Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat(R) Inhaler in Patients with Chronic Obstructive Pulmonary Disease. Adv Ther. 2015 Sep;32(9):809-22. doi: 10.1007/s12325-015-0239-8. Epub 2015 Sep 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olodaterol	Small molecule	5 ug	Inhaled
Subject	Olodaterol	Small molecule	10 ug	Inhaled
Subject	Tiotropium	Other / unclassified	1.25 ug	Inhaled
Subject	Tiotropium	Other / unclassified	2.5 ug	Inhaled
Subject	Tiotropium	Other / unclassified	5 ug	Inhaled