BI 443651 Methacholine Challenge

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: BI 443651

• Registration Number: NCT03135899
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-02
• Study Start: 2017-05-18
• Primary Completion: 2018-02-07
• Study Completion: 2018-02-21
• Status Verified: 2019-11
• Results First Submitted: 2019-11-07
• Results First Submitted QC: 2019-11-07
• Last Update Submitted: 2019-11-07
• Results First Posted: 2019-11-27
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BI 443651	BI 443651	-

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 1	Baseline and Day 2	Absolute change from baseline in maximum forced expiratory volume within 1 second (FEV1) reduction following bolus methacholine challenge in Part 1 was defined as the difference between the maximum reduction in FEV1 obtained during the treatment challenge and during the baseline challenge.
Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 2.	Baseline and Day 2	Absolute change from baseline in maximum FEV1 reduction following bolus methacholine challenge in Part 2 was defined as the difference between the maximum reduction in FEV1 obtained during the treatment challenge and during the baseline challenge.

Secondary Outcome Measures

Name	Time	Method
Relative Change From Baseline in FEV1 Area Under the Curve Over the Time Interval From 0 to Timepoint tz (FEV1 AUC0-tz) Following Bolus Methacholine Challenge in Part 1	Baseline and Day 2	Relative change from baseline in FEV1 area under the curve over the time interval from 0 to timepoint tz (FEV1 AUC0-tz) following bolus methacholine challenge in Part 1 was defined as the ratio of FEV1 AUC0-tz obtained during the treatment challenge and during the baseline challenge, where the time tz refers to the last time point before recovery of FEV1 to within 95% of post-diluent value.
Time to Recovery of FEV1 to Within 95% of Post-diluent Value in Part 1	Day 2	Time to recovery of FEV1 to within 95% of post-diluent value in Part 1 was defined as the time from maximum reduction to last time before recovery to within 95% of the value obtained pre-methacholine challenge during the respective challenge.
Relative Change From Baseline in FEV1 Area Under the Curve Over the Time Interval From 0 to Timepoint tz (FEV1 AUC0-tz) Following Bolus Methacholine Challenge in Part 2	Baseline and Day 2	Relative change from baseline in FEV1 area under the curve over the time interval from 0 to timepoint tz (FEV1 AUC0-tz) following bolus methacholine challenge in Part 2 was defined as the ratio of FEV1 AUC0-tz obtained during the treatment challenge and during the baseline challenge, where the time tz refers to the last time point before recovery of FEV1 to within 95% of post-diluent value. Geometric mean is actually adjusted geometric mean. Standard error presented here is a geometric standard error.
Time to Recovery of FEV1 to Within 95% of Post-diluent Value in Part 2	Day 2	Time to recovery of FEV1 to within 95% of post-diluent value in Part 2 was defined as the time from maximum reduction to last time before recovery to within 95% of the value obtained pre-methacholine challenge during the respective challenge. Median is actually model-based median.

Trial Locations

Locations (1)

The Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom