At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL Delivered by the Respimat Inhaler in Japanese Patients With COPD
In Brief
A Phase 2 clinical trial evaluating BI 1744 CL 2 µg, BI 1744 CL 5 µg, and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 328 participants across 48 sites.
Detailed Summary
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.
Study Details
Timeline
Interventions
2 puffs of 1 µg/actuation delivered by the Respimat® inhaler
2 puffs of 2.5 µg/actuation delivered by the Respimat® inhaler
2 puffs of 5 µg/actuation delivered by Respimat®
2 puffs delivered by the Respimat® inhaler