Trial Outcomes & Findings for BI 671800 in Asthmatic Patients on Inhaled Corticosteroids (NCT NCT01103349)
NCT ID: NCT01103349
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
243 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, multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of oral BI 671800 ED 400 mg b.i.d., montelukast 10 mg q.d., or placebo in symptomatic asthma patients on Fluticasone propionate Hydrofluoralkane Metered Dose Inhaler (100μg b.i.d.).
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 BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet 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 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
Montelukast 10 mg qd
Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
95
|
81
|
67
|
|
Overall Study
COMPLETED
|
84
|
74
|
63
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet 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 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
Montelukast 10 mg qd
Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
5
|
3
|
|
Overall Study
Consent withdrawn
|
1
|
0
|
0
|
|
Overall Study
Incorrectly included in the trial
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
did not want to take trial medication
|
0
|
1
|
0
|
|
Overall Study
forgot to take medication
|
0
|
0
|
1
|
Baseline Characteristics
BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
Baseline characteristics by cohort
| Measure |
Placebo
n=95 Participants
Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
n=81 Participants
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
Montelukast 10 mg qd
n=67 Participants
Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 12.64 • n=113 Participants
|
41.8 years
STANDARD_DEVIATION 12.67 • n=163 Participants
|
41.7 years
STANDARD_DEVIATION 11.97 • n=160 Participants
|
41.6 years
STANDARD_DEVIATION 12.42 • n=483 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=113 Participants
|
50 Participants
n=163 Participants
|
42 Participants
n=160 Participants
|
147 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=113 Participants
|
31 Participants
n=163 Participants
|
25 Participants
n=160 Participants
|
96 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
8 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=113 Participants
|
77 Participants
n=163 Participants
|
65 Participants
n=160 Participants
|
235 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=113 Participants
|
12 Participants
n=163 Participants
|
6 Participants
n=160 Participants
|
29 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=113 Participants
|
66 Participants
n=163 Participants
|
56 Participants
n=160 Participants
|
199 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
11 Participants
n=483 Participants
|
|
Percentage of predicted forced expiratory volume in one second (FEV1)
|
68.089 Percentage of predicted FEV1
STANDARD_DEVIATION 10.9109 • n=113 Participants
|
69.286 Percentage of predicted FEV1
STANDARD_DEVIATION 10.5542 • n=163 Participants
|
69.842 Percentage of predicted FEV1
STANDARD_DEVIATION 10.5288 • n=160 Participants
|
68.986 Percentage of predicted FEV1
STANDARD_DEVIATION 10.6644 • n=483 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 randomized patients who received at least one dose of treatment and had both baseline and the post-baseline measurement at 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=81 Participants
Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
n=74 Participants
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
Montelukast 10 mg qd
n=62 Participants
Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast 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
|
-0.859 FEV1 percent predicted
Standard Deviation 1.029
|
3.011 FEV1 percent predicted
Standard Deviation 1.082
|
1.510 FEV1 percent predicted
Standard Deviation 1.181
|
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 randomized patients who received at least one dose of treatment and had both baseline and the post-baseline measurement at 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=81 Participants
Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
n=74 Participants
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
Montelukast 10 mg qd
n=62 Participants
Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|
|
Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment
|
-0.418 Score on a scale
Standard Deviation 0.081
|
-0.698 Score on a scale
Standard Deviation 0.085
|
-0.598 Score on a scale
Standard Deviation 0.093
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
BI 671800 400 mg Bid
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Montelukast 10 mg qd
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=95 participants at risk
Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
n=81 participants at risk
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
Montelukast 10 mg qd
n=67 participants at risk
Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/95 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 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%
1/81 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 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%
0/67 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 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=95 participants at risk
Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
BI 671800 400 mg Bid
n=81 participants at risk
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
|
Montelukast 10 mg qd
n=67 participants at risk
Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.3%
5/95 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
6.2%
5/81 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
4.5%
3/67 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 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
|
5.3%
5/95 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
4.9%
4/81 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
6.0%
4/67 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 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
|
8.4%
8/95 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 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%
2/81 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
|
3.0%
2/67 • Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 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
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