Trial Outcomes & Findings for BI 671800 ED in Steroid-naive Asthmatic Patients (NCT NCT01092143)
NCT ID: NCT01092143
Last Updated: 2022-05-31
Results Overview
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit. MMRM in the statistical test comments is mixed effects model with repeated measures.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
389 participants
Primary outcome timeframe
Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.
Results posted on
2022-05-31
Participant Flow
This was a Phase IIa multi-centre, multi-national, randomized, double-blind, placebo-controlled, parallel group, double-dummy study investigating the efficacy, safety and tolerability of BI 671800 ED (50, 200 and 400 mg b.i.d.) compared to fluticasone propionate 110 mcg 2 puffs b.i.d. and placebo in symptomatic steroid-naïve asthma patients.
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all subjects as required.
Participant milestones
| Measure |
Placebo
Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 50 mg Bid
Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 200 mg Bid
Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
Fluticasone 220 mcg Bid
Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
78
|
77
|
84
|
79
|
71
|
|
Overall Study
Treated
|
78
|
77
|
83
|
79
|
71
|
|
Overall Study
COMPLETED
|
63
|
70
|
80
|
72
|
63
|
|
Overall Study
NOT COMPLETED
|
15
|
7
|
4
|
7
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 50 mg Bid
Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 200 mg Bid
Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
Fluticasone 220 mcg Bid
Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
5
|
1
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Consent withdrawn
|
2
|
1
|
0
|
1
|
3
|
|
Overall Study
Not treated
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
did not reversibility criteria
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Increased Albuterol use for >2 days
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Ineligible patient
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Drop in FEV1 at visit 9
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Patient travel
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Non compliance with study medication
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Randomized by mistake
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
BI 671800 ED in Steroid-naive Asthmatic Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=78 Participants
Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 50 mg Bid
n=77 Participants
Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 200 mg Bid
n=83 Participants
Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
n=79 Participants
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
Fluticasone 220 mcg Bid
n=71 Participants
Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
Total
n=388 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 12.99 • n=93 Participants
|
39.1 years
STANDARD_DEVIATION 11.53 • n=4 Participants
|
35.1 years
STANDARD_DEVIATION 11.09 • n=27 Participants
|
37.5 years
STANDARD_DEVIATION 12.23 • n=483 Participants
|
39.4 years
STANDARD_DEVIATION 12.20 • n=36 Participants
|
37.4 years
STANDARD_DEVIATION 12.06 • n=10 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
36 Participants
n=36 Participants
|
199 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
35 Participants
n=36 Participants
|
189 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
100 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
57 Participants
n=483 Participants
|
45 Participants
n=36 Participants
|
276 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
57 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
71 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
47 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
42 Participants
n=36 Participants
|
211 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Percentage of predicted forced expiratory volume in one second (FEV1)
|
70.811 Percentage of predicted FEV1
STANDARD_DEVIATION 8.6801 • n=93 Participants
|
68.812 Percentage of predicted FEV1
STANDARD_DEVIATION 10.6335 • n=4 Participants
|
72.626 Percentage of predicted FEV1
STANDARD_DEVIATION 9.9901 • n=27 Participants
|
71.646 Percentage of predicted FEV1
STANDARD_DEVIATION 7.4747 • n=483 Participants
|
70.481 Percentage of predicted FEV1
STANDARD_DEVIATION 9.7577 • n=36 Participants
|
70.904 Percentage of predicted FEV1
STANDARD_DEVIATION 9.4014 • n=10 Participants
|
PRIMARY outcome
Timeframe: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.Population: Statistical analysis was performed on the Full Analysis Set (FAS): Randomized patients who received at least one dose of treatment and had both baseline and at least one post-baseline measurement at or before 6 weeks for the primary efficacy variable.
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit. MMRM in the statistical test comments is mixed effects model with repeated measures.
Outcome measures
| Measure |
Placebo
n=63 Participants
Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 50 mg Bid
n=69 Participants
Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 200 mg Bid
n=81 Participants
Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
n=71 Participants
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
Fluticasone 220 mcg Bid
n=63 Participants
Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
|
-2.010 FEV1 percent predicted
Standard Deviation 1.187
|
1.073 FEV1 percent predicted
Standard Deviation 1.144
|
1.580 FEV1 percent predicted
Standard Deviation 1.074
|
1.967 FEV1 percent predicted
Standard Deviation 1.133
|
6.610 FEV1 percent predicted
Standard Deviation 1.194
|
SECONDARY outcome
Timeframe: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.Population: Statistical analysis was performed on the Full Analysis Set (FAS): Randomized patients who received at least one dose of treatment and had both baseline and at least one post-baseline measurement at or before 6 weeks for the primary efficacy variable.
Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment. The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted.
Outcome measures
| Measure |
Placebo
n=64 Participants
Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 50 mg Bid
n=69 Participants
Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 200 mg Bid
n=81 Participants
Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
n=71 Participants
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
Fluticasone 220 mcg Bid
n=63 Participants
Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|---|---|
|
Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment
|
-0.616 Score on a scale
Standard Deviation 0.081
|
-0.543 Score on a scale
Standard Deviation 0.078
|
-0.696 Score on a scale
Standard Deviation 0.074
|
-0.677 Score on a scale
Standard Deviation 0.078
|
-0.949 Score on a scale
Standard Deviation 0.082
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
BI 671800 50 mg Bid
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
BI 671800 200 mg Bid
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 671800 400 mg Bid
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Fluticasone 220 mcg Bid
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=78 participants at risk
Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 50 mg Bid
n=77 participants at risk
Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 200 mg Bid
n=83 participants at risk
Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
n=79 participants at risk
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
Fluticasone 220 mcg Bid
n=71 participants at risk
Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
1.3%
1/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
|
Eye disorders
Vision blurred
|
1.3%
1/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
1.3%
1/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
1.3%
1/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
|
Nervous system disorders
Headache
|
1.3%
1/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
1.3%
1/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
Other adverse events
| Measure |
Placebo
n=78 participants at risk
Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 50 mg Bid
n=77 participants at risk
Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 200 mg Bid
n=83 participants at risk
Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
n=79 participants at risk
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
Fluticasone 220 mcg Bid
n=71 participants at risk
Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
4/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
0.00%
0/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
2.4%
2/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
2.5%
2/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
1.4%
1/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
6.5%
5/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
1.2%
1/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
3.8%
3/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
2.8%
2/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
2/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
2.6%
2/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
3.6%
3/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
6.3%
5/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
2.8%
2/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
5.2%
4/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
3.6%
3/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
5.1%
4/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
5.6%
4/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.3%
8/78 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
5.2%
4/77 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
1.2%
1/83 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
2.5%
2/79 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
4.2%
3/71 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
Additional Information
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Phone: 1-800-243-0127
Email: [email protected]
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