CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 198 enrolled
Drug / intervention
Placebo +5 moredrug
Likely dose
Formoterol 12 mcgfrom 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/NCT01013753
NCT01013753Phase 2Completed
CompareCT.gov

A Randomised, Double-Blind, Placebo- and Active-Controlled, Incomplete Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Once Daily Treatment of 4 Doses of BI 1744 CL Inhalation Solution Delivered by the Respimat® in Patients With Asthma

Boehringer Ingelheim·interventional·Posted Nov 16, 2009·Updated Jun 27, 2014

In Brief

A Phase 2 clinical trial evaluating Placebo, Olodaterol (BI 1744) high, and 4 other interventions for Asthma. Completed, enrolled 198 participants across 27 sites in 6 countries.

Detailed Summary

The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustria, Germany, Poland, Romania, Slovakia, Slovenia
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 16, 2009
Enrollment StartFeb 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.6 years ago

Interventions

Placebodrug

Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler

Olodaterol (BI 1744) highdrug

Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat

Olodaterol (BI 1744) mediumdrug

Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat

Olodaterol (BI 1744) very lowdrug

Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat

Formoterol 12 mcgdrug

Determine efficacy and safety of 12 mcg Formoterol dose inhaled orally twice daily from the Aerolizer in comparison to other treatment groups

Olodaterol (BI 1744) lowdrug

Determine efficacy and safety of 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat