At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomised, Double-blind, Double-dummy, Placebo-controlled, 4-way Cross-over Study to Characterise the 24-hour Forced, Expiratory Volume After 1 Second (FEV1) Time Profiles of BI 1744 CL 5µg and 10µg (Oral Inhalation, Delivered by the Respimat® Inhaler) and Tiotropium Bromide 18µg (Oral Inhalation, Delivered by the HandiHaler®) After 6 Weeks of Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Olodaterol (BI1744) Low, Placebo (for olodaterol BI1744), and 3 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 108 participants across 15 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Low dose inhaled orally once daily from Respimat inhaler
Placebo (olodaterol low and high dose)delivered by Respimat
Placebo (Tiotropium 18 mcg) delivered by HandiHaler
High dose inhaled orally once daily from Respimat inhaler
18mcg inhaled once daily from Handihaler