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Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy

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ClinicalTrials.gov Identifier: NCT02075255
Recruitment Status : Completed
First Posted : March 3, 2014
Results First Posted : October 17, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Biological: Benralizumab
Biological: Placebo
Enrollment 220
Recruitment Details  
Pre-assignment Details 369 participants signed informed consent. 271 entered run in/OCS optimization period. 220 participants were randomized to receive treatment with benralizumab 30 mg Q4W, Q8W, or placebo. Of the 220 patients randomised, all (100.0%) received treatment with study drug
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks Placebo administered subcutaneously
Period Title: Overall Study
Started 72 73 75
Completed 68 69 72
Not Completed 4 4 3
Reason Not Completed
Study specific withdrawal criteria             0             1             1
Withdrawal by Subject             4             1             0
Lost to Follow-up             0             0             1
Adverse Event             0             0             1
Death             0             2             0
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo Total
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks Placebo administered subcutaneously Total of all reporting groups
Overall Number of Baseline Participants 72 73 75 220
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 73 participants 75 participants 220 participants
50.2  (12.0) 52.9  (10.1) 49.9  (11.7) 51.0  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 73 participants 75 participants 220 participants
Female
40
  55.6%
47
  64.4%
48
  64.0%
135
  61.4%
Male
32
  44.4%
26
  35.6%
27
  36.0%
85
  38.6%
1.Primary Outcome
Title Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control
Hide Description Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Median (95% Confidence Interval)
Unit of Measure: Percent
75.00
(50.00 to 83.30)
75.00
(60.00 to 87.50)
25.00
(0.00 to 33.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 33.3
Confidence Interval (2-Sided) 95%
16.70 to 50.00
Estimation Comments Hodges-Lehmann estimate is used.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 37.50
Confidence Interval (2-Sided) 95%
20.80 to 50.00
Estimation Comments Hodges Lehmann estimate is used.
2.Secondary Outcome
Title Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control
Hide Description Number and percentage of patients in different categories of percent reduction from baseline in final OCS dose.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Measure Type: Count of Participants
Unit of Measure: Participants
>=90% reduction
24
  33.3%
27
  37.0%
9
  12.0%
>=75% reduction
38
  52.8%
37
  50.7%
15
  20.0%
>=50% reduction
48
  66.7%
48
  65.8%
28
  37.3%
>0% reduction
55
  76.4%
58
  79.5%
40
  53.3%
No change or any increase
17
  23.6%
15
  20.5%
35
  46.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method proportional odds model
Comments Controlling for treatment group, region, and baseline OCS dose.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.09
Confidence Interval (2-Sided) 95%
2.22 to 7.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method proportional odds model
Comments Controlling for treatment group, region, and baseline OCS dose.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.12
Confidence Interval (2-Sided) 95%
2.22 to 7.63
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control for Patients With Baseline Eosinophils >=300/uL
Hide Description Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline blood eosinophil >=300/uL
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 62 61 64
Median (95% Confidence Interval)
Unit of Measure: Percent
75.00
(60.00 to 100.00)
75.00
(60.00 to 91.70)
0.00
(0.00 to 28.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 50.00
Confidence Interval (2-Sided) 95%
25.00 to 66.70
Estimation Comments Hodges Lehmann estimate is used.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 50.00
Confidence Interval (2-Sided) 95%
25.00 to 66.70
Estimation Comments Hodges Lehmann estimate is used.
4.Secondary Outcome
Title The Percentage of Patients With ≥50% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control
Hide Description Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Measure Type: Count of Participants
Unit of Measure: Participants
48
  66.7%
48
  65.8%
28
  37.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.59
Confidence Interval (2-Sided) 95%
1.79 to 7.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.03
Confidence Interval (2-Sided) 95%
1.57 to 5.86
Estimation Comments [Not Specified]
5.Secondary Outcome
Title The Proportion of Eligible Patients With ≥100% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control
Hide Description Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, eligible for 100% reduction (ie, patients with baseline OCS dose <= 12.5 mg)
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 39 42 42
Measure Type: Number
Unit of Measure: Participants
22 22 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.23
Confidence Interval (2-Sided) 95%
1.92 to 14.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.19
Confidence Interval (2-Sided) 95%
1.58 to 11.12
Estimation Comments [Not Specified]
6.Secondary Outcome
Title The Proportion of Patients With ≤5.0 mg Reduction on Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control.
Hide Description Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Measure Type: Number
Unit of Measure: Participants
22 25 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.21 to 0.83
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.27 to 1.01
Estimation Comments [Not Specified]
7.Secondary Outcome
Title The Proportion of Patients With Average Final OCS Dose ≤5.0 mg Daily at Visit 14, While Maintaining Asthma Control
Hide Description Final OCS dose is the dose at Week 28. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Measure Type: Number
Unit of Measure: Participants
44 43 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.16
Confidence Interval (2-Sided) 95%
1.60 to 6.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.74
Confidence Interval (2-Sided) 95%
1.41 to 5.31
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number and Percentage of Patients With ≥1 Asthma Exacerbation
Hide Description Number and percentage of patients with at least one post randomisation asthma exacerbation.
Time Frame Immediately following the randomisation through Study Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Measure Type: Count of Participants
Unit of Measure: Participants
19
  26.4%
17
  23.3%
39
  52.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
0.16 to 0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.14 to 0.56
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Time to the First Asthma Exacerbation
Hide Description Time to the first occurrence of asthma exacerbation post randomisation
Time Frame The time from randomisation to the date of first asthma exacerbation over 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
155 [2] 
(111 to NA)
[1]
median survival time is not estimable due to number of exacerbations had not reached 50%.
[2]
Upper 95% CI for median is not estimable due to the curve representing the upper confidence limit of the survival function is above 50%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments Including covariates treatment group, region, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.22 to 0.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments Including covariates treatment group, region, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
0.17 to 0.57
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Time to the First Asthma Exacerbation Requiring Hospitalization or ER Visit
Hide Description Time to the first exacerbation requiring hospitalization or ER visit post randomisation
Time Frame The time from randomisation to the date of first asthma exacerbation associated with hospitalization or ER over 28 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
median survival time is not estimable due to number of exacerbations resulting hospitalization or ER visit had not reached 50%.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.291
Comments [Not Specified]
Method Regression, Cox
Comments Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.14 to 1.64
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Regression, Cox
Comments Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.01 to 0.63
Estimation Comments [Not Specified]
11.Secondary Outcome
Title The Annualized Rate of Asthma Exacerbation
Hide Description The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator adjusted by the time of follow-up.
Time Frame The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: events/year
0.83
(0.55 to 1.26)
0.54
(0.34 to 0.88)
1.83
(1.33 to 2.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method negative binomial model
Comments Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.27 to 0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method negative binomial model
Comments Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.17 to 0.53
Estimation Comments [Not Specified]
12.Secondary Outcome
Title The Annualized Rate of Asthma Exacerbations That Are Associated With an Emergency Room Visit or a Hospitalization
Hide Description The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator that are associated with an emergency room visit or a hospitalization adjusted by the time of follow-up.
Time Frame The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: events/year
0.14
(0.05 to 0.38)
0.02
(0.00 to 0.18)
0.32
(0.16 to 0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.187
Comments [Not Specified]
Method negative binomial model
Comments Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
0.13 to 1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method negative binomial model
Comments Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
0.01 to 0.63
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Days in Hospital Due to Asthma
Hide Description Number of days in hospital due to asthma, if none, 0 day is considered
Time Frame The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Mean (Standard Deviation)
Unit of Measure: Days
0.3  (1.41) 0.5  (3.86) 1.2  (6.66)
14.Secondary Outcome
Title Change From Baseline to Week 28 in Pre-bronchodilator FEV1
Hide Description Baseline is defined as the last non-missing value prior to the first dose of study treatment. Change from baseline to Week 28 in two treatment groups is compared to placebo group.
Time Frame Change from baseline at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 68 68 73
Mean (Standard Deviation)
Unit of Measure: Liter
0.230  (0.429) 0.255  (0.508) 0.114  (0.401)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments [Not Specified]
Method Mixed Models Analysis
Comments Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.105
Confidence Interval (2-Sided) 95%
-0.040 to 0.251
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method Mixed Models Analysis
Comments Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.112
Confidence Interval (2-Sided) 95%
-0.033 to 0.258
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline to Week 28 in Asthma Symptom Scores (Total)
Hide Description Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Time Frame Change from baseline at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 67 68 67
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.58  (1.03) -0.77  (1.03) -0.58  (1.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.947
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.35 to 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.291
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.51 to 0.16
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline to Week 28 in Asthma Symptom Scores (Daytime)
Hide Description Asthma symptoms during daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma). Lower score (0) is indicating better asthma symptom, while higher score (3) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Time Frame Change from baseline at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 67 69 69
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.32  (0.56) -0.44  (0.52) -0.32  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.998
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.00
Confidence Interval (2-Sided) 95%
-0.18 to 0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.30 to 0.05
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline to Week 28 in Asthma Symptom Scores (Nighttime)
Hide Description Asthma symptoms during night time are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma). Lower score (0) is indicating better asthma symptom, while higher score (3) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Time Frame Change from baseline at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 67 68 67
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.27  (0.51) -0.34  (0.54) -0.27  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.00
Confidence Interval (2-Sided) 95%
-0.17 to 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.480
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.23 to 0.11
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline to Week 28 in Rescue Medication Use
Hide Description Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this will be considered as missing. The number of inhalations (puffs) per day will be calculated as follows: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of day inhaler puffs + 2 x [number of day nebulizer times].
Time Frame Change from baseline at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 67 68 67
Mean (Standard Deviation)
Unit of Measure: number of puffs per day
-1.39  (2.86) -2.58  (4.36) -1.07  (2.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.397
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-1.44 to 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.41
Confidence Interval (2-Sided) 95%
-2.42 to -0.41
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline to Week 28 in Home Lung Function (Morning Peak Expiratory Flow)
Hide Description Morning peak expiratory flow change from baseline to week 28. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data.
Time Frame Change from baseline at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 67 68 67
Mean (Standard Deviation)
Unit of Measure: Liter/min
32.697  (89.457) 43.022  (73.303) 10.884  (69.356)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 19.25
Confidence Interval (2-Sided) 95%
-6.58 to 45.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 30.01
Confidence Interval (2-Sided) 95%
4.26 to 55.76
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline to Week 28 in Home Lung Function (Evening Peak Expiratory Flow)
Hide Description Evening peak expiratory flow change from baseline to week 28. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data
Time Frame Change from baseline at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 67 69 66
Mean (Standard Deviation)
Unit of Measure: Liter/min
21.885  (83.136) 34.157  (69.287) 2.933  (72.302)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.237
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.19
Confidence Interval (2-Sided) 95%
-10.08 to 40.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 31.52
Confidence Interval (2-Sided) 95%
6.32 to 56.71
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline to Week 28 in the Proportion of Nights With Awakening Due to Asthma Requiring Rescue Medication
Hide Description Baseline is defined as the proportion of nights from the evening of study day -14 to the morning of study day 1.Each timepoint is calculated as bi-weekly proportions based on daily diary data. If more than 50% of data are missing in a 14 day period then this will be considered as missing.Proportion of nights with noctural awakenings is defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data.
Time Frame Change from baseline at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 67 68 67
Mean (Standard Deviation)
Unit of Measure: Proportion
-0.158  (0.283) -0.2  (0.337) -0.186  (0.344)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.742
Comments [Not Specified]
Method Mixed Models Analysis
Comments Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.08 to 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.693
Comments [Not Specified]
Method Mixed Models Analysis
Comments Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.11 to 0.07
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline to Week 28 in ACQ-6
Hide Description ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
Time Frame Change from baseline at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 66 66 67
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.86  (0.95) -1.09  (1.09) -0.68  (1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.55 to 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.86 to -0.23
Estimation Comments [Not Specified]
23.Secondary Outcome
Title ACQ-6 Responders (Improvement) at Week 28
Hide Description Improvement is defined as ACQ-6 (End of treatment - baseline) <= -0.5. No change is defined as ACQ-6 (End of treatment - baseline) >-0.5 and <0.5. Deterioration is defined as ACQ-6 (End of treatment - baseline) >= 0.5. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations and rescue medication.Scores range from 0 (totally controlled) to 6 (severely uncontrolled). Baseline is defined as the last non-missing value prior to randomisation. End of treatment is defined as week 28. Patients with missing or non-evaluable ACQ-6 at week 28 are considered non-responder.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Measure Type: Number
Unit of Measure: Participants
41 46 41
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.658
Comments [Not Specified]
Method Regression, Logistic
Comments Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.165
Confidence Interval (2-Sided) 95%
0.592 to 2.295
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.155
Comments [Not Specified]
Method Regression, Logistic
Comments Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.661
Confidence Interval (2-Sided) 95%
0.826 to 3.340
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline at Week 28 in AQLQ(S)+12 (Overall)
Hide Description AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.
Time Frame Change from baseline at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 66 67 68
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.90  (0.93) 1.05  (1.04) 0.67  (1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method Mixed Models Analysis
Comments Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-0.08 to 0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.14 to 0.76
Estimation Comments [Not Specified]
25.Secondary Outcome
Title AQLQ(s)+12 Responders (Improvement) at Week 28
Hide Description AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. Improvement is defined as AQLQ(S)+12 (End of treatment - baseline)>=0.5. No change is defined as AQLQ(S)+12 (End of treatment - baseline) >-0.5 and <0.5. Deterioration is defined as AQLQ(S)+12 (End of treatment - baseline) <= -0.5. Baseline is defined as the last AQLQ(S)+12 score prior to randomisation. End of treatment is defined as week 28. Patients with missing or non-evaluable score at week 28 are considered as non-responder.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Measure Type: Number
Unit of Measure: Participants
43 44 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.220
Comments [Not Specified]
Method Regression, Logistic
Comments Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.538
Confidence Interval (2-Sided) 95%
0.773 to 3.060
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Regression, Logistic
Comments Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.783
Confidence Interval (2-Sided) 95%
0.882 to 3.605
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Extent of Exposure
Hide Description Duration of exposure from first dose date to last dose date.
Time Frame From first dose to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Mean (Standard Deviation)
Unit of Measure: Days
162.53  (30.09) 159.77  (35.781) 167.05  (10.697)
27.Secondary Outcome
Title Serum Concentration of Benralizumab
Hide Description Pre-dose serum concentrations at each visit
Time Frame Pre-first dose to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 71 72 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Baseline (n=69, 71)
NA [1] 
(NA%)
NA [1] 
(NA%)
Week 4 (n=67, 71)
804.37
(52.77%)
721.42
(52.30%)
week 8 (n=66, 69)
1152.96
(53.16%)
1019.65
(89.51%)
Week 12 (n=68, 67)
1319.14
(66.05%)
1057.91
(125.74%)
Week 16 (n=67,67)
1337.98
(118.90%)
303.54
(144.53%)
Week 24 (n=65, 66)
1162.62
(151.35%)
185.17
(278.32%)
Week 28 (n=65, 65)
1125.96
(173.79%)
684.57
(205.67%)
Week 36 (n=2, 4)
11.11
(2140.87%)
5.92
(1230.68%)
[1]
Value is less than lower limit of quantification
28.Secondary Outcome
Title Anti-drug Antibody Response
Hide Description Number and percentage of patients in different ADA response categories
Time Frame From baseline to follow-up Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 72 73 75
Measure Type: Count of Participants
Unit of Measure: Participants
Positive at any visit Number Analyzed 72 participants 73 participants 75 participants
5
   6.9%
7
   9.6%
6
   8.0%
Baseline and Post-baseline Postive Number Analyzed 68 participants 69 participants 75 participants
0
   0.0%
0
   0.0%
3
   4.0%
Only post-baseline positive Number Analyzed 71 participants 70 participants 75 participants
5
   7.0%
6
   8.6%
3
   4.0%
Only baseline positive Number Analyzed 69 participants 72 participants 75 participants
0
   0.0%
1
   1.4%
0
   0.0%
Persistently positive Number Analyzed 71 participants 70 participants 75 participants
4
   5.6%
6
   8.6%
5
   6.7%
Transient positive Number Analyzed 71 participants 70 participants 75 participants
1
   1.4%
0
   0.0%
1
   1.3%
29.Secondary Outcome
Title Percent Change From Baseline in Blood Eosinophil Counts
Hide Description Percent change from baseline in blood eosinophil counts at week 28
Time Frame Change from baseline at Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 63 62 66
Mean (Standard Deviation)
Unit of Measure: percent change
-97.4  (12.93) -94.9  (16.54) 45.5  (239.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.4 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -162.2
Confidence Interval (2-Sided) 95%
-220.1 to -104.3
Estimation Comments Percent change
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg q.8 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -159.4
Confidence Interval (2-Sided) 95%
-217.9 to -100.9
Estimation Comments Percent change
30.Secondary Outcome
Title Total Lung Capacity
Hide Description Change from baseline in total lung capacity
Time Frame From baseline to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Global Sputum Substudy
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 22 26 23
Mean (Standard Deviation)
Unit of Measure: Liter
Week 12 (n=17, 23, 17) -0.02  (0.95) -0.07  (0.68) -0.30  (1.08)
Week 28 (n=14, 18, 15) 0.11  (1.31) -0.21  (0.70) -0.47  (1.47)
31.Secondary Outcome
Title Residual Volume
Hide Description Change from baseline in residual volume
Time Frame From baseline to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Global Sputum Substudy
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 22 26 23
Mean (Standard Deviation)
Unit of Measure: Liter
Week 12 (n=17, 23, 17) 0.02  (1.00) -0.22  (0.74) -0.35  (1.03)
Week 28 (n=14, 18, 15) 0.07  (1.34) -0.31  (0.71) -0.41  (1.27)
32.Secondary Outcome
Title Vital Capacity
Hide Description Change from baseline in vital capacity
Time Frame From baseline to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Global Sputum Substudy
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 22 26 23
Mean (Standard Deviation)
Unit of Measure: Liter
Week 12 (n=17, 24, 18) 0.15  (0.80) 0.18  (0.35) 0.13  (0.89)
Week 28 (n=14, 18, 15) 0.15  (0.41) 0.11  (0.48) -0.08  (0.41)
33.Secondary Outcome
Title Functional Residual Capacity
Hide Description Change from baseline in functional residual capacity
Time Frame From baseline to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Global Sputum Substudy
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 22 26 23
Mean (Standard Deviation)
Unit of Measure: Liter
Week 12 (n=17,23, 18) -0.05  (1.06) -0.09  (0.74) -0.38  (0.99)
Week 28 (n=13,18, 15) -0.15  (1.49) -0.26  (0.74) -0.43  (1.25)
34.Secondary Outcome
Title Inspiratory Capacity
Hide Description Change from baseline in inspiratory capacity
Time Frame From baseline to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Global Sputum Substudy
Arm/Group Title Benralizumab 30 mg q.4 Weeks Benralizumab 30 mg q.8 Weeks Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
Placebo administered subcutaneously
Overall Number of Participants Analyzed 22 26 23
Mean (Standard Deviation)
Unit of Measure: Liter
Week 12 (n=17, 23, 17) 0.44  (1.22) 0.14  (0.88) -0.01  (0.40)
Week 28 (n=14, 17, 15) 0.52  (1.16) 0.09  (1.01) -0.02  (0.40)
Time Frame Include events occurred from the start of study treatment to the end of study (up to 36 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benra 30 mg q.4 Weeks Benra 30 mg q.8 Weeks Placebo
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks Placebo administered subcutaneously
All-Cause Mortality
Benra 30 mg q.4 Weeks Benra 30 mg q.8 Weeks Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Benra 30 mg q.4 Weeks Benra 30 mg q.8 Weeks Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/72 (9.72%)      7/73 (9.59%)      14/75 (18.67%)    
Cardiac disorders       
Atrial fibrillation  1  0/72 (0.00%)  0 1/73 (1.37%)  1 0/75 (0.00%)  0
Atrial flutter  1  0/72 (0.00%)  0 0/73 (0.00%)  0 1/75 (1.33%)  1
Cardiac failure acute  1  0/72 (0.00%)  0 1/73 (1.37%)  1 0/75 (0.00%)  0
Pericarditis  1  0/72 (0.00%)  0 0/73 (0.00%)  0 1/75 (1.33%)  1
Gastrointestinal disorders       
Oesophagitis  1  0/72 (0.00%)  0 1/73 (1.37%)  1 0/75 (0.00%)  0
Umbilical hernia  1  1/72 (1.39%)  1 0/73 (0.00%)  0 0/75 (0.00%)  0
General disorders       
Adverse drug reaction  1  1/72 (1.39%)  1 0/73 (0.00%)  0 0/75 (0.00%)  0
Hepatobiliary disorders       
Gallbladder polyp  1  0/72 (0.00%)  0 1/73 (1.37%)  1 0/75 (0.00%)  0
Immune system disorders       
Hypersensitivity  1  1/72 (1.39%)  1 0/73 (0.00%)  0 0/75 (0.00%)  0
Infections and infestations       
Atypical pneumonia  1  0/72 (0.00%)  0 0/73 (0.00%)  0 1/75 (1.33%)  1
Chronic sinusitis  1  0/72 (0.00%)  0 0/73 (0.00%)  0 1/75 (1.33%)  1
Colonic abscess  1  0/72 (0.00%)  0 0/73 (0.00%)  0 1/75 (1.33%)  1
Influenza  1  0/72 (0.00%)  0 0/73 (0.00%)  0 2/75 (2.67%)  2
Pneumonia  1  0/72 (0.00%)  0 2/73 (2.74%)  2 3/75 (4.00%)  3
Pneumonia staphylococcal  1  0/72 (0.00%)  0 0/73 (0.00%)  0 1/75 (1.33%)  1
Urinary tract infection bacterial  1  1/72 (1.39%)  1 0/73 (0.00%)  0 0/75 (0.00%)  0
Urosepsis  1  1/72 (1.39%)  1 0/73 (0.00%)  0 0/75 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  1/72 (1.39%)  1 0/73 (0.00%)  0 0/75 (0.00%)  0
Nervous system disorders       
Presyncope  1  0/72 (0.00%)  0 1/73 (1.37%)  1 0/75 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis  1  1/72 (1.39%)  1 0/73 (0.00%)  0 0/75 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma  1  3/72 (4.17%)  3 1/73 (1.37%)  1 4/75 (5.33%)  5
Sleep apnoea syndrome  1  0/72 (0.00%)  0 0/73 (0.00%)  0 1/75 (1.33%)  1
Status asthmaticus  1  0/72 (0.00%)  0 0/73 (0.00%)  0 3/75 (4.00%)  3
Skin and subcutaneous tissue disorders       
Dermatitis atopic  1  1/72 (1.39%)  1 0/73 (0.00%)  0 0/75 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Benra 30 mg q.4 Weeks Benra 30 mg q.8 Weeks Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/72 (47.22%)      34/73 (46.58%)      49/75 (65.33%)    
Ear and labyrinth disorders       
Vertigo  1  1/72 (1.39%)  5 3/73 (4.11%)  3 2/75 (2.67%)  2
Gastrointestinal disorders       
Nausea  1  1/72 (1.39%)  1 0/73 (0.00%)  0 3/75 (4.00%)  3
Infections and infestations       
Bronchitis  1  5/72 (6.94%)  7 8/73 (10.96%)  10 12/75 (16.00%)  13
Influenza  1  3/72 (4.17%)  3 1/73 (1.37%)  1 5/75 (6.67%)  5
Nasopharyngitis  1  11/72 (15.28%)  13 12/73 (16.44%)  14 15/75 (20.00%)  17
Oral candidiasis  1  0/72 (0.00%)  0 0/73 (0.00%)  0 4/75 (5.33%)  4
Rhinitis  1  2/72 (2.78%)  2 6/73 (8.22%)  7 2/75 (2.67%)  2
Sinusitis  1  5/72 (6.94%)  8 4/73 (5.48%)  5 8/75 (10.67%)  11
Upper respiratory tract infection  1  4/72 (5.56%)  7 5/73 (6.85%)  6 5/75 (6.67%)  7
Musculoskeletal and connective tissue disorders       
Back pain  1  2/72 (2.78%)  2 2/73 (2.74%)  2 4/75 (5.33%)  5
Nervous system disorders       
Headache  1  5/72 (6.94%)  7 6/73 (8.22%)  10 4/75 (5.33%)  4
Respiratory, thoracic and mediastinal disorders       
Asthma  1  6/72 (8.33%)  11 1/73 (1.37%)  2 14/75 (18.67%)  17
Cough  1  2/72 (2.78%)  2 1/73 (1.37%)  1 4/75 (5.33%)  4
Dyspnoea  1  2/72 (2.78%)  2 1/73 (1.37%)  1 4/75 (5.33%)  4
Vascular disorders       
Hypertension  1  2/72 (2.78%)  2 3/73 (4.11%)  3 2/75 (2.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ’s Confidential Information without AZ’s written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
Results Point of Contact
Name/Title: Mitchell Goldman, Global Clinical Lead Benralizumab
Organization: AstraZeneca
Phone: +1 301 398 0323
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02075255     History of Changes
Other Study ID Numbers: D3250C00020
First Submitted: February 14, 2014
First Posted: March 3, 2014
Results First Submitted: July 24, 2017
Results First Posted: October 17, 2017
Last Update Posted: June 8, 2018