At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 644 enrolled
Drug / intervention
Olodaterol (BI 1744) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized 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 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 mcg [2 Actuations of 2.5 mcg] and 10 mcg [2 Actuations of 5 mcg]) Delivered by the Respimat® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD
In Brief
A Phase 3 clinical trial evaluating Olodaterol (BI 1744) and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 644 participants across 51 sites in 4 countries.
Detailed Summary
This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesChina, Germany, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartFeb 2009
Primary CompletionSep 2010
TodayJul 2026
First PostedOct 31, 2008
Enrollment StartFeb 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.7 years ago
Interventions
Olodaterol (BI 1744)drug
Comparison of low and high doses on efficacy and safety in COPD patients
Olodaterol (BI 1744)drug
Comparison of low and high doses on efficacy and safety in COPD patients
Placebodrug
Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler