Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD)

Phase 2 Completed 360 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 micrograms tiotropium bromide solution for inhalation, delivered by the Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).

Timeline

Start: 2008-06
Primary completion: 2009-02
Completion: —

Outcome

Met primary endpoint

registry p = 0.0337; Mean Difference (Final Values) 0.057 (95% CI 0.004 to 0.110) NCT00696020 ↗

Publications

Maltais F, Hamilton A, Voss F, Maleki-Yazdi MR. Dose Determination for a Fixed-Dose Drug Combination: A Phase II Randomized Controlled Trial for Tiotropium/Olodaterol Versus Tiotropium in Patients with COPD. Adv Ther. 2019 Apr;36(4):962-968. doi: 10.1007/s12325-019-00911-y. Epub 2019 Mar 6.

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
Subject	Tiotropium	Other / unclassified	5 ug	Inhaled