Trial Outcomes & Findings for Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma (NCT NCT01947946)
NCT ID: NCT01947946
Last Updated: 2015-11-24
Results Overview
The number of asthma exacerbations over 48 weeks treatment will be counted
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
13 participants
Primary outcome timeframe
48 weeks treatment
Results posted on
2015-11-24
Participant Flow
The study was stopped with 13 patients randomised
Participant milestones
| Measure |
Benra 30 mg q.4 Weeks
Fixed 30 mg dose of benralizumab every 4 weeks.
|
Benra 30 Mg-Placebo q.8 Weeks
Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
|
Placebo
A (Dummy) injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
Baseline characteristics by cohort
| Measure |
Benra 30 mg q.4 Weeks
n=3 Participants
Fixed 30 mg dose of benralizumab every 4 weeks.
|
Benra 30 Mg-Placebo q.8 Weeks
n=5 Participants
Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
|
Placebo
n=5 Participants
A (Dummy) injection
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 15.70 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 6.38 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 6.35 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 9.32 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 48 weeks treatmentPopulation: Patients from the full analysis set will be used. All patients randomized and receiving any investigational product will be included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
The number of asthma exacerbations over 48 weeks treatment will be counted
Outcome measures
| Measure |
Benra 30 mg q.4 Weeks
n=3 Participants
Fixed 30 mg dose of benralizumab every 4 weeks.
|
Benra 30 Mg-Placebo q.8 Weeks
n=3 Participants
Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
|
Placebo
n=3 Participants
A (Dummy) injection
|
|---|---|---|---|
|
Asthma Exacerbations Over 48 Weeks Treatment
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
Adverse Events
Benra 30 mg q.4 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Benra 30 Mg-Placebo q.8 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Benra 30 mg q.4 Weeks
n=3 participants at risk
Fixed 30 mg dose of benralizumab every 4 weeks.
|
Benra 30 Mg-Placebo q.8 Weeks
n=5 participants at risk
Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
|
Placebo
n=5 participants at risk
A (Dummy) injection
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Prolonged expiration
|
0.00%
0/3
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place