At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 37 enrolled
Drug / intervention
BI 443651 +1 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 Two Part Phase I, Multiple-dose, Single- and Double-blind, Randomised, Double-dummy, Placebo-controlled, Four-way Crossover Study to Assess Safety and Tolerability of BI 443651 Via Respimat® Versus Placebo Via Respimat® in Subjects With Mild Asthma Following Methacholine Challenge.
In Brief
A Phase 1 clinical trial evaluating BI 443651 and Placebo for Asthma. Completed, enrolled 37 participants across 1 site.
Detailed Summary
The primary objective of this study is to investigate safety and tolerability of three consecutive administrations, 12 hours apart, at three different dose-levels of BI 443651 administered via oral inhalation in male and female mild asthmatic subjects after a bolus methacholine challenge.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartMay 2017
Primary CompletionFeb 2018
Study CompletionFeb 2018
TodayJul 2026
First PostedMay 2, 2017
Enrollment StartMay 18, 2017
Primary CompletionFeb 7, 2018
Study CompletionFeb 21, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.2 years ago
Interventions
BI 443651drug
Three doses, each 12 hours apart
Placebodrug
Three doses, each 12 hours apart