An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.
Pulmonary Disease, Chronic Obstructive
Drug: BEA 2180 BR
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multinational, Randomised, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison Over 24 Weeks of Three Doses (50µg, 100µg, 200µg) of BEA 2180 BR to Tiotropium 5µg, Delivered by the Respimat Inhaler and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)|
- The primary endpoint in this study is trough FEV1 response after 24 weeks. [ Time Frame: 24 weeks ]
- Trough FEV1 response after 1, 2, 4, 8, 12, and 18 weeks [ Time Frame: 24 weeks ]
|Study Start Date:||September 2007|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Show 178 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim Pharmaceuticals|