Trial Outcomes & Findings for BI 443651 Methacholine Challenge (NCT NCT03135899)
NCT ID: NCT03135899
Last Updated: 2019-11-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
Baseline and Day 2
Results posted on
2019-11-27
Participant Flow
Patients with mild asthma were recruited in this trial, which was split into 2 parts. Part 1 was a multiple-dose, single-blind, double-dummy, randomized, 4-way crossover trial with dose ordered sequences. Part 2 was a multiple-dose, double-blind, double-dummy, randomized, 4-way crossover trial.
All patients were screened for eligibility to participate in the trial. Patients attended a specialist site which ensured that they (the patients) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria was violated.
Participant milestones
| Measure |
Placebo/BI 443651 100/400/1200 Micro Gram (μg) - Part 1
Patients were orally administered placebo matched to BI 443651 inhalation solution in period 1, followed by BI 443651 100 micro gram (μg) inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100 μg/Placebo/BI 443651 400/1200 μg - Part 1
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by placebo matched to BI 443651 inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100/400 μg/Placebo/BI 443651 1200 μg - Part 1
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, placebo matched to BI 443651 inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100/400/1200 μg/Placebo - Part 1
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, BI 443651 1200 μg inhalation solution in period 3 and placebo matched to BI 443651 inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
Placebo/BI 443651 100/400/1200 μg - Part 2
Patients were orally administered placebo matched to BI 443651 inhalation solution in period 1, followed by BI 443651 100 μg inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 400/1200 μg/Placebo/BI 443651 100 μg - Part 2
Patients were orally administered BI 443651 400 μg inhalation solution in period 1, followed by BI 443651 1200 μg inhalation solution in period 2, placebo matched to BI 443651 inhalation solution in period 3 and BI 443651 100 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100 μg/Placebo/BI 443651 1200/400 μg - Part 2
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by placebo matched to BI 443651 inhalation solution in period 2, BI 443651 1200 μg inhalation solution in period 3 and BI 443651 400 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 1200/400/100 μg/Placebo - Part 2
Patients were orally administered BI 443651 1200 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, BI 443651 100 μg inhalation solution in period 3 and placebo matched to BI 443651 inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
8
|
9
|
8
|
8
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
8
|
7
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo/BI 443651 100/400/1200 Micro Gram (μg) - Part 1
Patients were orally administered placebo matched to BI 443651 inhalation solution in period 1, followed by BI 443651 100 micro gram (μg) inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100 μg/Placebo/BI 443651 400/1200 μg - Part 1
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by placebo matched to BI 443651 inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100/400 μg/Placebo/BI 443651 1200 μg - Part 1
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, placebo matched to BI 443651 inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100/400/1200 μg/Placebo - Part 1
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, BI 443651 1200 μg inhalation solution in period 3 and placebo matched to BI 443651 inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
Placebo/BI 443651 100/400/1200 μg - Part 2
Patients were orally administered placebo matched to BI 443651 inhalation solution in period 1, followed by BI 443651 100 μg inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 400/1200 μg/Placebo/BI 443651 100 μg - Part 2
Patients were orally administered BI 443651 400 μg inhalation solution in period 1, followed by BI 443651 1200 μg inhalation solution in period 2, placebo matched to BI 443651 inhalation solution in period 3 and BI 443651 100 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100 μg/Placebo/BI 443651 1200/400 μg - Part 2
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by placebo matched to BI 443651 inhalation solution in period 2, BI 443651 1200 μg inhalation solution in period 3 and BI 443651 400 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 1200/400/100 μg/Placebo - Part 2
Patients were orally administered BI 443651 1200 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, BI 443651 100 μg inhalation solution in period 3 and placebo matched to BI 443651 inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Failed spirometry,unable to repeat visit
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
BI 443651 Methacholine Challenge
Baseline characteristics by cohort
| Measure |
Placebo/BI 443651 100/400/1200 Micro Gram (μg) - Part 1
n=1 Participants
Patients were orally administered placebo matched to BI 443651 inhalation solution in period 1, followed by BI 443651 100 micro gram (μg) inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100 μg/Placebo/BI 443651 400/1200 μg - Part 1
n=1 Participants
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by placebo matched to BI 443651 inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100/400 μg/Placebo/BI 443651 1200 μg - Part 1
n=1 Participants
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, placebo matched to BI 443651 inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100/400/1200 μg/Placebo - Part 1
n=1 Participants
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, BI 443651 1200 μg inhalation solution in period 3 and placebo matched to BI 443651 inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
Placebo/BI 443651 100/400/1200 μg - Part 2
n=8 Participants
Patients were orally administered placebo matched to BI 443651 inhalation solution in period 1, followed by BI 443651 100 μg inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 400/1200 μg/Placebo/BI 443651 100 μg - Part 2
n=9 Participants
Patients were orally administered BI 443651 400 μg inhalation solution in period 1, followed by BI 443651 1200 μg inhalation solution in period 2, placebo matched to BI 443651 inhalation solution in period 3 and BI 443651 100 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 100 μg/Placebo/BI 443651 1200/400 μg - Part 2
n=8 Participants
Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by placebo matched to BI 443651 inhalation solution in period 2, BI 443651 1200 μg inhalation solution in period 3 and BI 443651 400 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
BI 443651 1200/400/100 μg/Placebo - Part 2
n=8 Participants
Patients were orally administered BI 443651 1200 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, BI 443651 100 μg inhalation solution in period 3 and placebo matched to BI 443651 inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42 Years
n=99 Participants
|
41 Years
n=107 Participants
|
59 Years
n=206 Participants
|
35 Years
n=157 Participants
|
39.1 Years
STANDARD_DEVIATION 10.5 • n=390 Participants
|
36.1 Years
STANDARD_DEVIATION 10.3 • n=16 Participants
|
35.4 Years
STANDARD_DEVIATION 11.1 • n=3 Participants
|
35.9 Years
STANDARD_DEVIATION 11.7 • n=6 Participants
|
37.4 Years
STANDARD_DEVIATION 10.6 • n=114 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
6 Participants
n=390 Participants
|
8 Participants
n=16 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
34 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
8 Participants
n=390 Participants
|
9 Participants
n=16 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
37 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
7 Participants
n=390 Participants
|
9 Participants
n=16 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
28 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 2Population: Methacholine set (MCS): The MCS included all patients in the TS who provided at least one pair (baseline and end-of-treatment) of evaluable measures of spirometry parameters that were not excluded due to use of rescue medication within 3 hours (h) after start of bolus methacholine challenge.
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.
Outcome measures
| Measure |
Placebo - Part 1
n=4 Participants
Patients were orally administered 4 actuations, thrice 12 hours (h) apart, of placebo matched with BI 443651 inhalation solution via Respimat® inhaler.
|
BI 443651 100 μg - Part 1
n=4 Participants
Patients were orally administered 1 actuation of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 400 μg - Part 1
n=4 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 1200 μg - Part 1
n=4 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 300 μg inhalation solution via Respimat® inhaler.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 1
|
0.018 Litres (L)
Standard Deviation 0.554
|
0.390 Litres (L)
Standard Deviation 0.261
|
-0.195 Litres (L)
Standard Deviation 0.431
|
0.272 Litres (L)
Standard Deviation 0.268
|
PRIMARY outcome
Timeframe: Baseline and Day 2Population: MCS
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.
Outcome measures
| Measure |
Placebo - Part 1
n=31 Participants
Patients were orally administered 4 actuations, thrice 12 hours (h) apart, of placebo matched with BI 443651 inhalation solution via Respimat® inhaler.
|
BI 443651 100 μg - Part 1
n=31 Participants
Patients were orally administered 1 actuation of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 400 μg - Part 1
n=32 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 1200 μg - Part 1
n=31 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 300 μg inhalation solution via Respimat® inhaler.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 2.
|
0.005 Litres (L)
Standard Error 0.056
|
0.064 Litres (L)
Standard Error 0.056
|
-0.032 Litres (L)
Standard Error 0.055
|
-0.152 Litres (L)
Standard Error 0.056
|
SECONDARY outcome
Timeframe: Baseline and Day 2Population: MCS
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.
Outcome measures
| Measure |
Placebo - Part 1
n=4 Participants
Patients were orally administered 4 actuations, thrice 12 hours (h) apart, of placebo matched with BI 443651 inhalation solution via Respimat® inhaler.
|
BI 443651 100 μg - Part 1
n=4 Participants
Patients were orally administered 1 actuation of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 400 μg - Part 1
n=4 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 1200 μg - Part 1
n=4 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 300 μg inhalation solution via Respimat® inhaler.
|
|---|---|---|---|---|
|
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 Ratio
Standard Deviation 0.849
|
0.625 Ratio
Standard Deviation 0.262
|
0.925 Ratio
Standard Deviation 0.364
|
0.296 Ratio
Standard Deviation 0.218
|
SECONDARY outcome
Timeframe: Baseline and Day 2Population: MCS
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.
Outcome measures
| Measure |
Placebo - Part 1
n=31 Participants
Patients were orally administered 4 actuations, thrice 12 hours (h) apart, of placebo matched with BI 443651 inhalation solution via Respimat® inhaler.
|
BI 443651 100 μg - Part 1
n=31 Participants
Patients were orally administered 1 actuation of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 400 μg - Part 1
n=32 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 1200 μg - Part 1
n=31 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 300 μg inhalation solution via Respimat® inhaler.
|
|---|---|---|---|---|
|
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 Ratio
Standard Error 1.152
|
0.665 Ratio
Standard Error 1.152
|
0.799 Ratio
Standard Error 1.150
|
0.729 Ratio
Standard Error 1.152
|
SECONDARY outcome
Timeframe: Day 2Population: MCS
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.
Outcome measures
| Measure |
Placebo - Part 1
n=4 Participants
Patients were orally administered 4 actuations, thrice 12 hours (h) apart, of placebo matched with BI 443651 inhalation solution via Respimat® inhaler.
|
BI 443651 100 μg - Part 1
n=4 Participants
Patients were orally administered 1 actuation of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 400 μg - Part 1
n=4 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 1200 μg - Part 1
n=4 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 300 μg inhalation solution via Respimat® inhaler.
|
|---|---|---|---|---|
|
Time to Recovery of FEV1 to Within 95% of Post-diluent Value in Part 1
|
0.775 hours (h)
Interval 0.283 to 2.752
|
0.452 hours (h)
Interval 0.217 to 1.185
|
0.751 hours (h)
Interval 0.311 to 2.336
|
0.597 hours (h)
Interval 0.266 to 0.996
|
SECONDARY outcome
Timeframe: Day 2Population: MCS
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.
Outcome measures
| Measure |
Placebo - Part 1
n=31 Participants
Patients were orally administered 4 actuations, thrice 12 hours (h) apart, of placebo matched with BI 443651 inhalation solution via Respimat® inhaler.
|
BI 443651 100 μg - Part 1
n=31 Participants
Patients were orally administered 1 actuation of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 400 μg - Part 1
n=32 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 1200 μg - Part 1
n=31 Participants
Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 300 μg inhalation solution via Respimat® inhaler.
|
|---|---|---|---|---|
|
Time to Recovery of FEV1 to Within 95% of Post-diluent Value in Part 2
|
0.65 h
Interval 0.33 to 0.74
|
0.48 h
Interval 0.3 to 0.52
|
0.44 h
Interval 0.3 to 0.48
|
0.32 h
Interval 0.16 to 0.48
|
Adverse Events
Placebo - Part 1 & Part 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 443651 100 Microgram (μg) - Part 1 & Part 2
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
BI 443651 400 μg - Part 1 & Part 2
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
BI 443651 1200 μg - Part 1 & Part 2
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo - Part 1 & Part 2
n=35 participants at risk
Patients were orally administered 4 actuations of placebo matched with BI 443651 inhalation solution via Respimat® inhaler.
|
BI 443651 100 Microgram (μg) - Part 1 & Part 2
n=35 participants at risk
Patients were orally administered 1 actuation of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 400 μg - Part 1 & Part 2
n=36 participants at risk
Patients were orally administered 4 actuations of BI 443651 100 μg inhalation solution via Respimat® inhaler.
|
BI 443651 1200 μg - Part 1 & Part 2
n=36 participants at risk
Patients were orally administered 4 actuations of BI 443651 300 μg inhalation solution via Respimat® inhaler.
|
|---|---|---|---|---|
|
General disorders
Chest discomfort
|
0.00%
0/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
0.00%
0/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
5.6%
2/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
30.6%
11/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
2.9%
1/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
5.6%
2/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
2.8%
1/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
2.9%
1/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
2.9%
1/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
2.8%
1/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
5.6%
2/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
14.3%
5/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
33.3%
12/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
41.7%
15/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
|
Nervous system disorders
Headache
|
17.1%
6/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
20.0%
7/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
8.3%
3/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
8.3%
3/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
40.0%
14/35 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
30.6%
11/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
41.7%
15/36 • From the first drug administration until 14 days after the last drug administration, up to 16 days.
Treated set (TS): The TS included all patients who had been randomised and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patients received.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER