drugset / Trial / NCT03135899

BI 443651 Methacholine Challenge

NCT03135899 ↗

Phase 1 Completed 37 enrolled Boehringer Ingelheim
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2017-05-18
Primary completion
2018-02-07
Completion
2018-02-21

Outcome

Met primary endpoint

registry Placebo - Part 2 vs BI 443651 1200 μg - Part 2; Mean Difference (Final Values) -0.157 (90% CI -0.266 to -0.047) NCT03135899 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 443651 Unknown — Inhaled

Indications