Phase 1
Completed N=37
BI 443651 Methacholine Challenge
Source: ClinicalTrials.gov NCT03135899 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 1 — 0.018; 0.390; -0.195; 0.272 Litres (L)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 1 |
0.018; 0.390; -0.195; 0.272 | — |
| PRIMARY Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 2. |
0.005; 0.064; -0.032; -0.152 | — |
| SECONDARY 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 |
1.097; 0.625; 0.925; 0.296 | — |
| SECONDARY 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 |
0.863; 0.665; 0.799; 0.729 | — |
| SECONDARY Time to Recovery of FEV1 to Within 95% of Post-diluent Value in Part 1 |
0.775; 0.452; 0.751; 0.597 | — |
| SECONDARY Time to Recovery of FEV1 to Within 95% of Post-diluent Value in Part 2 |
0.65; 0.48; 0.44; 0.32 | — |
Eligibility Criteria
Inclusion criteria
- Male or female subjects must have a diagnosis of asthma by a physician at least 3 months prior to screening. The diagnosis of asthma must meet the following spirometric criteria:
-- Pre-bronchodilator clinic measured FEV1 >=70% of predicted normal (calculated by the Global Lung Function Initiative equation (GLI)) measured >= 8 hours after the last use of short acting bronchodilator at the screening visit and on the day of randomisation.
- Age >= 18 = 40 years and the diagnosis has not yet been recorded in the subject's medical files, the investigator should assess whether the subject's medical history (e.g. symptoms and prescribed medications) confirms the subject suffered from asthma since before the age of 40. If so, this subject may be considered for inclusion after consultation with the sponsor.
- ACQ value = 18.5 and 5 pack years (1 pack year = 20 cigarettes per day for 1 year of 5 cigarettes per day for 4 years)
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03135899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.