At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 389 enrolled
Drug / intervention
BI 671800 +3 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.
A Randomized, Double Blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 6-week Treatment With Oral Doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in Steroid-naïve Patients With Persistent Asthma
In Brief
A Phase 2 clinical trial evaluating BI 671800, Fluticasone propionate placebo, and 2 other interventions for Asthma. Completed, enrolled 389 participants across 92 sites in 10 countries.
Detailed Summary
This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustralia, Canada, Colombia, Mexico, New Zealand, Peru, Philippines, South Korea, Taiwan, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionMar 2011
TodayJul 2026
First PostedMar 24, 2010
Enrollment StartMar 18, 2010
Primary CompletionMar 26, 2011
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 16.3 years ago
Interventions
BI 671800drug
BI 671800
Fluticasone propionate placebodrug
Placebo matching Fluticasone propionate
Fluticasone propionatedrug
Fluticasone propionate
BI 671800 Placebodrug
Placebo matching BI 671800