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 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, Olodaterol (BI1744) High, and 3 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 122 participants across 12 sites in 4 countries.
Detailed Summary
The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (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
High dose inhaled orally once daily from Respimat inhaler
18 mcg inhaled once daily from HandiHaler
Placebo (olodaterol low and high dose) delivered by Respimat
Placebo (Tiotropium 18 mcg) delivered by HandiHaler