CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 906 enrolled
Drug / intervention
Olodaterol (BI 1744) +4 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/NCT00793624
NCT00793624Phase 3Completed
CompareCT.gov

A Randomised, Double-blind, Double-dummy, 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 µg [2 Actuations of 2.5 ug] and 10 ug [2 Actuations of 5 ug]) Delivered by the Respimat® Inhaler, and 48 Weeks of Twice Daily Foradil® (12 µg) Delivered by the Aerolizer® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim·interventional·Posted Nov 19, 2008·Updated Jun 27, 2014

In Brief

A Phase 3 clinical trial evaluating Olodaterol (BI 1744), Formoterol, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 906 participants across 93 sites in 20 countries.

Detailed Summary

The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Brazil, Canada, Croatia, Czechia, Denmark, Finland, Germany, Hong Kong, India, Italy, Malaysia, Norway, Philippines, South Africa, South Korea, Spain, Sweden, Thailand, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2008
Enrollment StartFeb 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.6 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

Formoteroldrug

Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients

Placebodrug

Placebo for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients

Placebodrug

Placebo for comparison Formoterolon safety and efficacy in COPD patients