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A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation (SOLANA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02869438
Recruitment Status : Completed
First Posted : August 17, 2016
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition Asthma
Interventions Drug: Benralizumab
Other: Placebo
Enrollment 233
Recruitment Details  
Pre-assignment Details 233 participants were randomized to receive treatment in study D3250C00038 (Solana) with benralizumab 30 mg or placebo. Of the 233 patients randomised, all (100.0%) received treatment with study drug. 118 (50.6%) patients received benralizumab 30 mg and 115 (49.4%) patients received placebo.
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description 12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days). 12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Period Title: Overall Study
Started 118 115
Completed 115 113
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             1             0
Adverse Event             1             0
Withdrawal by Subject             1             2
Arm/Group Title Benra 30 mg Placebo Total
Hide Arm/Group Description 12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days). 12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days). Total of all reporting groups
Overall Number of Baseline Participants 118 115 233
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 118 participants 115 participants 233 participants
51.9  (13.62) 50.9  (12.34) 51.4  (12.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 115 participants 233 participants
Female
74
  62.7%
83
  72.2%
157
  67.4%
Male
44
  37.3%
32
  27.8%
76
  32.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 118 participants 115 participants 233 participants
White 69 67 136
Black or African American 3 4 7
Asian 39 40 79
Other 7 4 11
1.Primary Outcome
Title Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1
Hide Description The average over the mean differences between benralizumab and placebo for change from baseline in pre-BD FEV1 is used to determine if the study is positive and to determine maintenance of effect. The first post baseline time point where the p-value for the mean difference between benralizumab and placebo is less than or equal to 0.05 is used to determine time to onset of effect.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Mean (Standard Deviation)
Unit of Measure: Liter
Day 28 Number Analyzed 118 participants 113 participants
0.21  (0.335) 0.132  (0.316)
Day 56 Number Analyzed 116 participants 113 participants
0.22  (0.367) 0.203  (0.349)
Day 84 Number Analyzed 114 participants 114 participants
0.209  (0.344) 0.149  (0.366)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0707
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.077
Confidence Interval (2-Sided) 95%
-0.007 to 0.161
Estimation Comments For Day 28
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7747
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.013
Confidence Interval (2-Sided) 95%
-0.077 to 0.104
Estimation Comments For Day 56
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0969
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.079
Confidence Interval (2-Sided) 95%
-0.014 to 0.173
Estimation Comments For Day 84
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1558
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.057
Confidence Interval (2-Sided) 95%
-0.022 to 0.135
Estimation Comments For average over Day 28, 56, and 84
2.Primary Outcome
Title Change From Baseline (Visit 4) to End of Treatment Day 84 (Visit 10) in Residual Volume (RV)
Hide Description Body plethysmography was performed for sub-study patients. Lung volume subdivisions measures were performed by the investigator or qualified designee according to ATS/ERS guidelines.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Body plethysmography sub-study analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 18 22
Mean (Standard Deviation)
Unit of Measure: Liter
-0.415  (0.609) -0.208  (0.528)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2847
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline RV, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.176
Confidence Interval (2-Sided) 95%
-0.505 to 0.153
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline to End of Treatment in Eosinophils Counts
Hide Description Percent change from baseline to Day 84
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Mean (Full Range)
Unit of Measure: Percentage
-88.55
(-100 to -12.5)
11.55
(-91.4 to 833.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline eosinophils counts, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -101.0
Confidence Interval (2-Sided) 95%
-118.9 to -83.06
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline (Visit 4) to Post Baseline Visits in Pre-BD FEV1
Hide Description Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, Day 84. [Note: Day 28, 56, 84 are presented in the Primary measure.]
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Mean (Standard Deviation)
Unit of Measure: Liter
Day 3 Number Analyzed 110 participants 107 participants
0.104  (0.223) 0.081  (0.269)
Day 7 Number Analyzed 118 participants 112 participants
0.125  (0.229) 0.081  (0.263)
Day 14 Number Analyzed 118 participants 113 participants
0.126  (0.3) 0.1  (0.287)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6384
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.015
Confidence Interval (2-Sided) 95%
-0.049 to 0.08
Estimation Comments For Day 3
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.046
Confidence Interval (2-Sided) 95%
-0.016 to 0.109
Estimation Comments For Day 7
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4959
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.026
Confidence Interval (2-Sided) 95%
-0.049 to 0.101
Estimation Comments For Day 14
5.Secondary Outcome
Title Change From Baseline to Post Baseline for Pre-BD FVC
Hide Description Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, and Day 84.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Mean (Standard Deviation)
Unit of Measure: Liter
Day 3 Number Analyzed 110 participants 107 participants
0.122  (0.247) 0.11  (0.267)
Day 7 Number Analyzed 118 participants 112 participants
0.138  (0.277) 0.099  (0.292)
Day 14 Number Analyzed 118 participants 113 participants
0.126  (0.331) 0.111  (0.312)
Day 28 Number Analyzed 118 participants 113 participants
0.21  (0.347) 0.134  (0.34)
Day 56 Number Analyzed 116 participants 113 participants
0.211  (0.404) 0.187  (0.369)
Day 84 Number Analyzed 114 participants 114 participants
0.213  (0.376) 0.131  (0.359)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8667
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.006
Confidence Interval (2-Sided) 95%
-0.062 to 0.073
Estimation Comments For Day 3
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2734
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.041
Confidence Interval (2-Sided) 95%
-0.033 to 0.115
Estimation Comments For Day 7
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7252
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.015
Confidence Interval (2-Sided) 95%
-0.068 to 0.098
Estimation Comments For Day 14
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0976
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.075
Confidence Interval (2-Sided) 95%
-0.014 to 0.164
Estimation Comments For Day 28
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6536
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.023
Confidence Interval (2-Sided) 95%
-0.077 to 0.122
Estimation Comments For Day 56
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0595
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.092
Confidence Interval (2-Sided) 95%
-0.004 to 0.188
Estimation Comments For Day 84
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1377
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.063
Confidence Interval (2-Sided) 95%
-0.02 to 0.147
Estimation Comments For average of Day 28, 56, 84.
6.Secondary Outcome
Title Percentage of Pre-BD FEV1 Responder
Hide Description Pre-BD FEV1 responder is defined as change from baseline in FEV1 >=100 ml
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Measure Type: Number
Unit of Measure: Percentage of Participants
Day 3 Number Analyzed 110 participants 107 participants
48.2 37.4
Day 7 Number Analyzed 118 participants 112 participants
48.3 42.0
Day 14 Number Analyzed 118 participants 113 participants
50.0 38.9
Day 28 Number Analyzed 118 participants 113 participants
57.6 46.9
Day 56 Number Analyzed 116 participants 113 participants
62.1 55.8
Day 84 Number Analyzed 114 participants 114 participants
57.9 51.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1604
Comments [Not Specified]
Method Regression, Logistic
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
0.85 to 2.58
Estimation Comments For Day 3
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3400
Comments [Not Specified]
Method Regression, Logistic
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
0.76 to 2.19
Estimation Comments For Day 7
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0924
Comments [Not Specified]
Method Regression, Logistic
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.58
Confidence Interval (2-Sided) 95%
0.93 to 2.70
Estimation Comments For Day 14
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1052
Comments [Not Specified]
Method Regression, Logistic
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.57
Confidence Interval (2-Sided) 95%
0.91 to 2.71
Estimation Comments For Day 28
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3271
Comments [Not Specified]
Method Regression, Logistic
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.77 to 2.21
Estimation Comments For Day 56
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3017
Comments [Not Specified]
Method Regression, Logistic
Comments Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.77 to 2.29
Estimation Comments For Day 84
7.Secondary Outcome
Title Change From Baseline 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 From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 14 Number Analyzed 118 participants 113 participants
-0.989  (0.901) -0.665  (0.837)
Day 28 Number Analyzed 118 participants 113 participants
-1.126  (0.947) -0.693  (0.869)
Day 56 Number Analyzed 115 participants 113 participants
-1.164  (1.132) -0.827  (1.023)
Day 84 Number Analyzed 114 participants 113 participants
-1.355  (1.146) -0.867  (1.114)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.293
Confidence Interval (2-Sided) 95%
-0.481 to -0.105
Estimation Comments For Day 14
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.402
Confidence Interval (2-Sided) 95%
-0.609 to -0.195
Estimation Comments For Day 28
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0117
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.312
Confidence Interval (2-Sided) 95%
-0.554 to -0.07
Estimation Comments For Day 56
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.472
Confidence Interval (2-Sided) 95%
-0.731 to -0.213
Estimation Comments For Day 84
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.395
Confidence Interval (2-Sided) 95%
-0.603 to -0.188
Estimation Comments For average of Day 28, 56, 84.
8.Secondary Outcome
Title Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Hide Description The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients’ recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 28 Number Analyzed 118 participants 113 participants
-16.956  (15.51) -9.444  (14.136)
Day 56 Number Analyzed 115 participants 113 participants
-19.941  (21.528) -13.802  (16.705)
Day 84 Number Analyzed 114 participants 113 participants
-23.343  (20.302) -14.385  (18.836)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.229
Confidence Interval (2-Sided) 95%
-10.832 to -3.626
Estimation Comments For Day 28
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0115
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.942
Confidence Interval (2-Sided) 95%
-10.538 to -1.346
Estimation Comments For Day 56
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.599
Confidence Interval (2-Sided) 95%
-13.3 to -3.898
Estimation Comments For Day 84
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.257
Confidence Interval (2-Sided) 95%
-11.133 to -3.38
Estimation Comments For average of Day 28, 56, 84.
9.Secondary Outcome
Title Change From Baseline to End of Treatment in FeNO
Hide Description Airway inflammation was evaluated via fractional exhaled nitric oxide (FeNO) measurement.
Time Frame From first IP dose to Day 84
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Full analysis set
Arm/Group Title Benra 30 mg Placebo
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12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Mean (Standard Deviation)
Unit of Measure: ppb
5.92  (45.295) 0.05  (27.634)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2825
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline FeNO value, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.414
Confidence Interval (2-Sided) 95%
-4.492 to 15.321
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to End of Treatment in Total Lung Capacity (TLC) for Sub-study Patients
Hide Description Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Time Frame From first IP dose to Day 84
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Hide Analysis Population Description
Body plethysmography sub-study analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 18 22
Mean (Standard Deviation)
Unit of Measure: Liter
-0.276  (0.677) -0.175  (0.418)
11.Secondary Outcome
Title Change From Baseline to End of Treatment in Ratio of Residual Volume (RV) and Total Lung Capacity (TLC) for Sub-study Patients
Hide Description Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Body plethysmography sub-study analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 18 22
Mean (Standard Deviation)
Unit of Measure: ratio
-0.05  (0.056) -0.026  (0.087)
12.Secondary Outcome
Title Change From Baseline to End of Treatment in Inspiratory Capacity (IC) for Sub-study Patients
Hide Description Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Body plethysmography sub-study analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 18 22
Mean (Standard Deviation)
Unit of Measure: Liter
0.119  (0.447) -0.268  (0.603)
13.Secondary Outcome
Title Change From Baseline to End of Treatment in Functional Residual Capacity (FRC) for Sub-study Patients
Hide Description Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Body plethysmography sub-study analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 18 22
Mean (Standard Deviation)
Unit of Measure: Liter
-0.394  (0.783) 0.093  (0.466)
14.Secondary Outcome
Title Change From Baseline to End of Treatment in Vital Capacity (VC) for Sub-study Patients
Hide Description Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Body plethysmography sub-study analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 18 22
Mean (Standard Deviation)
Unit of Measure: Liter
0.139  (0.245) 0.033  (0.676)
15.Secondary Outcome
Title Duration of IP Administration
Hide Description Duration of IP administration is last IP dose date - first IP dose +1.
Time Frame From first IP to last IP
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Safety analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Mean (Standard Deviation)
Unit of Measure: Days
55.9  (7.83) 56.2  (7.61)
16.Other Pre-specified Outcome
Title Serum Concentration of Benralizumab
Hide Description PK sample was collected pre-dose at each visit
Time Frame From first dose to end of treatment period (Day 84)
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PK analysis set
Arm/Group Title Benra 30 mg
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12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 117
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Baseline Number Analyzed 116 participants
1.95 [1] 
(NA%)
Day 3 Number Analyzed 91 participants
1266.78
(199.59%)
Day 7 Number Analyzed 112 participants
1449.47
(125.02%)
Day 14 Number Analyzed 116 participants
1317.92
(79.53%)
Day 28 Number Analyzed 114 participants
738.47
(80.77%)
Day 56 Number Analyzed 114 participants
1015.72
(59.74%)
Day 84 Number Analyzed 108 participants
1079.22
(73.24%)
[1]
Only 1 patient had PK concentration detectable, ie, PK concentration <LLOQ for 115 participants.
17.Other Pre-specified Outcome
Title PK Parameter of Benralizumab (Cmax)
Hide Description PK parameters are derived in patients with at least three qualifiable serum PK concentrations post first dose (collected on Day 3, 7, and either 14, or 28)
Time Frame First IP dose cycle (ie, data collected on Days 3, 7, 14 and 28)
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PK analysis set
Arm/Group Title Benra 30 mg
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 117
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1729.6
(36.8%)
18.Other Pre-specified Outcome
Title Anti-drug Antibody Responses
Hide Description Anti-drug antibody responses at baseline and post baseline, including nAb responses
Time Frame From first IP dose to end of treatment period (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Measure Type: Count of Participants
Unit of Measure: Participants
ADA prevalence Number Analyzed 117 participants 114 participants
7
   6.0%
2
   1.8%
nAb prevalence Number Analyzed 117 participants 114 participants
2
   1.7%
0
   0.0%
Both baseline and post baseline positive Number Analyzed 114 participants 113 participants
1
   0.9%
2
   1.8%
Only post baseline positive Number Analyzed 116 participants 113 participants
5
   4.3%
0
   0.0%
Only baseline positive Number Analyzed 115 participants 114 participants
1
   0.9%
0
   0.0%
19.Other Pre-specified Outcome
Title Change From Baseline to End of Treatment in PGI-S
Hide Description The patient global impression of severity (PGI-S) is a single item designed to capture the patient's perception of overall symptom severity at the time of the completion using a 6-point categorical response scale (no symptom [0] to very severe symptom [5])
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.2  (1.31) -0.8  (1.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0120
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes covariates of treatment, baseline PGI-S score, region, visit, treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.365
Confidence Interval (2-Sided) 95%
-0.649 to -0.081
Estimation Comments For Day 84
20.Other Pre-specified Outcome
Title Change From Baseline to End of Treatment in CGI-C
Hide Description Clinician global impression of change (CGI-C) is used for an overall evaluation of response to treatment. The investigator is asked to rate the degree of change in overall asthma status compare to the start of treatment. A 7-point rating scale is used from 1=very much improved to 7=very much worse.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Measure Type: Count of Participants
Unit of Measure: Participants
Very much improved
18
  15.3%
10
   8.7%
Much improved
39
  33.1%
36
  31.3%
Minimally improved
39
  33.1%
28
  24.3%
No change
17
  14.4%
28
  24.3%
Minimally worse
0
   0.0%
7
   6.1%
Much worse
0
   0.0%
1
   0.9%
Very much worse
0
   0.0%
0
   0.0%
Missing
5
   4.2%
5
   4.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments Responder analysis: responder is defined as Very much improved, improved, and minimally improved.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method Regression, Logistic
Comments Model includes covariates of treatment, region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.97
Confidence Interval (2-Sided) 95%
1.50 to 5.88
Estimation Comments For Day 84
21.Other Pre-specified Outcome
Title Change From Baseline to End of Treatment in PGI-C
Hide Description Patient global impression of change (PGI-C) is used for an overall evaluation of response to treatment. The patient is asked to rate the degree of change in overall asthma status compare to the start of treatment. A 7-point rating scale is used from 1=very much improved to 7=very much worse.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 118 115
Measure Type: Count of Participants
Unit of Measure: Participants
Very much improved
32
  27.1%
17
  14.8%
Much improved
42
  35.6%
35
  30.4%
Minimally improved
23
  19.5%
29
  25.2%
No change
14
  11.9%
27
  23.5%
Minimally worse
1
   0.8%
4
   3.5%
Much worse
1
   0.8%
1
   0.9%
Very much worse
1
   0.8%
0
   0.0%
Missing
4
   3.4%
2
   1.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg, Placebo
Comments Responder analysis: responder is defined as Very much improved, improved, and minimally improved.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0107
Comments [Not Specified]
Method Regression, Logistic
Comments Model includes covariates of treatment, region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.51
Confidence Interval (2-Sided) 95%
1.24 to 5.09
Estimation Comments For Day 84
22.Other Pre-specified Outcome
Title Change From Baseline to End of Treatment in Specific Airway Resistance (SGaw) for Sub-study Patients
Hide Description Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Body plethysmography sub-study analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 18 22
Mean (Standard Deviation)
Unit of Measure: 1/(kPa*sec)
-0.05  (0.146) 0.052  (0.224)
23.Other Pre-specified Outcome
Title Change From Baseline to End of Treatment in Airway Resistance (Raw) for Sub-study Patients
Hide Description Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Time Frame From first IP dose to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Body plethysmography sub-study analysis set
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description:
12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
Overall Number of Participants Analyzed 18 22
Mean (Standard Deviation)
Unit of Measure: kPa/L/sec
-0.233  (1.509) -0.2  (0.532)
Time Frame From informed consent form was signed to end of study (ie, Day 112 follow-up)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benra 30 mg Placebo
Hide Arm/Group Description 12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days). 12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
All-Cause Mortality
Benra 30 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/118 (0.00%)      0/115 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Benra 30 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/118 (0.85%)      7/115 (6.09%)    
Cardiac disorders     
Coronary artery disease  1  0/118 (0.00%)  0 1/115 (0.87%)  1
Immune system disorders     
Drug hypersensitivity  1  1/118 (0.85%)  1 0/115 (0.00%)  0
Infections and infestations     
Lower respiratory tract infection  1  0/118 (0.00%)  0 1/115 (0.87%)  1
Pneumonia  1  0/118 (0.00%)  0 2/115 (1.74%)  2
Nervous system disorders     
Generalised tonic-clonic seizure  1  0/118 (0.00%)  0 1/115 (0.87%)  1
Migraine  1  0/118 (0.00%)  0 1/115 (0.87%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/118 (0.00%)  0 2/115 (1.74%)  2
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Benra 30 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/118 (23.73%)      30/115 (26.09%)    
Infections and infestations     
Bronchitis  1  6/118 (5.08%)  6 3/115 (2.61%)  3
Nasopharyngitis  1  8/118 (6.78%)  9 6/115 (5.22%)  7
Upper respiratory tract infection  1  6/118 (5.08%)  7 6/115 (5.22%)  8
Respiratory, thoracic and mediastinal disorders     
Asthma  1  11/118 (9.32%)  11 18/115 (15.65%)  22
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Ubaldo Martin, Global Clinical Lead Benralizumab
Organization: AstraZeneca
Phone: +1 301 398 0163
EMail: Ubaldo.Martin@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02869438     History of Changes
Other Study ID Numbers: D3250C00038
2016-002094-36 ( EudraCT Number )
U1111-1185-6625 ( Other Identifier: WHO (UTN number) )
First Submitted: August 16, 2016
First Posted: August 17, 2016
Results First Submitted: July 23, 2019
Results First Posted: October 7, 2019
Last Update Posted: October 7, 2019