CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 625 enrolled
Drug / intervention
Olodaterol (BI1744) +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.

Search/NCT00782210
NCT00782210Phase 3Completed
CompareCT.gov

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)

Boehringer Ingelheim·interventional·Posted Oct 31, 2008·Updated Jun 9, 2014

In Brief

A Phase 3 clinical trial evaluating Olodaterol (BI1744) and placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 625 participants across 54 sites in 6 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). The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesAustralia, China, Germany, New Zealand, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2008
Enrollment StartNov 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.7 years ago

Interventions

Olodaterol (BI1744)drug

Comparison of low and high doses on efficacy and safety in COPD patients

Olodaterol (BI1744)drug

Comparison of low and high doses on efficacy and safety in COPD patients

placebodrug

Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler