CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 243 enrolled
Drug / intervention
BI 671800 +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/NCT01103349
NCT01103349Phase 2Completed
CompareCT.gov

Randomised, Double Blind, Double Dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 6 Weeks of Oral BI 671800 ED Twice Daily (b.i.d.), Montelukast Once Daily (q.d.) or Placebo in Symptomatic Asthmatic Patients on Low Dose Fluticasone Propionate MDI (Metered Dose Inhaler)

Boehringer Ingelheim·interventional·Posted Apr 14, 2010·Updated May 31, 2022

In Brief

A Phase 2 clinical trial evaluating BI 671800, Placebo, and 1 other intervention for Asthma. Completed, enrolled 243 participants across 53 sites in 9 countries.

Detailed Summary

This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustria, Germany, Italy, New Zealand, South Korea, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2010
Enrollment StartApr 20, 2010
Primary CompletionAug 9, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.2 years ago

Interventions

BI 671800drug

Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma

Placebodrug

Patients receive placebo capsules and/or encapsulated tablets

Montelukastdrug

Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma