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Study to Assess Functionality, Reliability, and Performance of a Single-Use Auto-Injector With Benralizumab Administered at Home (GRECO)

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: NCT02918071
Recruitment Status : Completed
First Posted : September 28, 2016
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Intervention Biological: Benralizumab
Enrollment 121
Recruitment Details  
Pre-assignment Details 121 participants receive treatment with benralizumab 30 mg at every 4 weeks schedule.
Arm/Group Title Benra 30 mg
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks
Period Title: Overall Study
Started 121
Completed 118
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Lost to Follow-up             1
Arm/Group Title Benra 30 mg
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks
Overall Number of Baseline Participants 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants
48.5  (14.95)
[1]
Measure Analysis Population Description: Full analysis set
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants
Female
77
  63.6%
Male
44
  36.4%
[1]
Measure Analysis Population Description: Full analysis set
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants
White 97
Black or African American 14
Asian 9
Other 1
[1]
Measure Analysis Population Description: Full analysis set
1.Primary Outcome
Title Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home
Hide Description Patients who are still in the study is defined as patients who had been treated for the specified timepoint. A successful administration is defined as an injection completed, an answer of “Yes” to all 5 questions in the Questionnaire, and adequately passed the visual inspection and function tests.
Time Frame Week 12, Week 16, Week 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all patients who were administered for at least one dose of Benralizumab.
Arm/Group Title Benra 30mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 121
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12 Number Analyzed 116 participants
113
  97.4%
Week 16 Number Analyzed 116 participants
112
  96.6%
Week 12 and 16 Number Analyzed 116 participants
108
  93.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 12)
Method of Estimation Estimation Parameter percentage
Estimated Value 97.4
Confidence Interval (2-Sided) 95%
92.63 to 99.46
Estimation Comments Percentage of patients successfully administered benralizumab with an AI at home (Week 12)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 96.6
Confidence Interval (2-Sided) 95%
91.41 to 99.05
Estimation Comments Percentage of patients who successfully administered benralizumab with an AI at home (Week 16)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 12 and 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 93.1
Confidence Interval (2-Sided) 95%
86.86 to 96.98
Estimation Comments Percentage of patients who successfully administered benralizumab with an AI at home (Week 12 and 16)
2.Primary Outcome
Title Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional
Hide Description AI evaluated as functional is defined as the device having adequately passed the visual inspection and function tests.
Time Frame Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all patients who were administered for at least one dose of Benralizumab.
Arm/Group Title Benra 30mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 121
Overall Number of Units Analyzed
Type of Units Analyzed: Auto-injector
234
Count of Units
Unit of Measure: Auto-injector
Week 12 Number Analyzed 117 Auto-injector [1] 
114
  97.4%
Week 16 Number Analyzed 117 Auto-injector [1] 
113
  96.6%
[1]
116 participants
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 12)
Method of Estimation Estimation Parameter Percentage
Estimated Value 97.4
Confidence Interval (2-Sided) 95%
92.69 to 99.47
Estimation Comments Percentage of patients returned functional AI administered at home (Week 12)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper Pearson Exact CI
Comments One sample confidence interval (Week 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 96.6
Confidence Interval (2-Sided) 95%
91.48 to 99.06
Estimation Comments Percentage of patients returned functional AI administered at home (Week 16)
3.Primary Outcome
Title Number of AI Devices Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)
Hide Description Number (%) of AI used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on AI dispensed for patients who were treated for the specific time point. This excludes AIs dispensed but never used for the treatment or the device not returned for evaluation.
Time Frame Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Units analyzed per row represents number of auto-injector used at each time point.
Arm/Group Title Benra 30mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 121
Overall Number of Units Analyzed
Type of Units Analyzed: Auto-injector
595
Count of Units
Unit of Measure: Auto-injector
Week 0 Number Analyzed 121 Auto-injector
0
   0.0%
Week 4 Number Analyzed 121 Auto-injector
1
   0.8%
Week 8 Number Analyzed 119 Auto-injector
1
   0.8%
Week 12 Number Analyzed 117 Auto-injector
3
   2.6%
Week 16 Number Analyzed 117 Auto-injector
4
   3.4%
Week 0 to Week 8 Number Analyzed 361 Auto-injector
2
   0.6%
Week 12 to Week 16 Number Analyzed 234 Auto-injector
7
   3.0%
Week 0 to Week 16 Number Analyzed 595 Auto-injector
9
   1.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 0)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.00 to 3.00
Estimation Comments Percentage of mulfunctioning AI used to administer benralizumab at home or clinic (Week 0)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 4)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.02 to 4.52
Estimation Comments Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 4)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 8)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.02 to 4.59
Estimation Comments Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 8)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 12)
Method of Estimation Estimation Parameter Percentage
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
0.53 to 7.31
Estimation Comments Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
0.94 to 8.52
Estimation Comments Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 16)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 0 to 8)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.07 to 1.99
Estimation Comments Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 8)
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 12 to 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
1.21 to 6.07
Estimation Comments Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12 to 16)
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Benra 30mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 0 to 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.69 to 2.85
Estimation Comments Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 16)
4.Secondary Outcome
Title Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score
Hide Description The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. 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. Smaller score indicates better controlled asthma.
Time Frame Week 0 (baseline) and weeks 4, 8, 12, 16, 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all patients who were administered for at least one dose of Benralizumab.
Arm/Group Title Benra 30mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 121
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 4 Number Analyzed 121 participants
-0.63  (0.99)
Week 8 Number Analyzed 119 participants
-0.91  (1.05)
Week 12 Number Analyzed 117 participants
-1.07  (1.02)
Week 16 Number Analyzed 116 participants
-1.13  (1.06)
Week 20 Number Analyzed 116 participants
-1.04  (1.08)
5.Secondary Outcome
Title The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab
Hide Description Mean PK Concentration at each visit
Time Frame Baseline, Week 8, Week 20, and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set - include all patients who had at least one quantifiable serum PK observation post first dose of Benralizumab.
Arm/Group Title Benra 30mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 121
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Baseline Number Analyzed 121 participants
NA [1] 
(NA%)
Week 8 Number Analyzed 118 participants
698.18
(186.455%)
Week 20 Number Analyzed 115 participants
787.51
(280.788%)
Week 28 Number Analyzed 117 participants
62.86
(469.359%)
[1]
Value is less than lower limit of quantification
6.Secondary Outcome
Title The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels
Hide Description Blood eosinophil counts by timepoint
Time Frame Baseline, Week 20, and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all patients who were administered for at least one dose of Benralizumab.
Arm/Group Title Benra 30mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 121
Median (Inter-Quartile Range)
Unit of Measure: cells/ uL
Baseline Number Analyzed 121 participants
230
(150 to 360)
Week 20 Number Analyzed 118 participants
20
(10 to 30)
Week 28 Number Analyzed 115 participants
20
(10 to 50)
7.Secondary Outcome
Title The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)
Hide Description Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive
Time Frame Baseline until Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all patients who were administered for at least one dose of Benralizumab.
Arm/Group Title Benra 30mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 121
Measure Type: Number
Unit of Measure: Participants
Positive at any visit Number Analyzed 121 participants
9
Base- and Post-baseline Positive Number Analyzed 120 participants
0
Only post-baseline positive Number Analyzed 120 participants
9
Only baseline positive Number Analyzed 121 participants
0
Persistently Positive Number Analyzed 120 participants
8
Transiently Positive Number Analyzed 120 participants
1
Time Frame 28 weeks.
Adverse Event Reporting Description

Adverse events were collected from the time the patient signed the informed consent, throughout the treatment period and including the follow-up period (through Week 28).

Serious adverse events were recorded from the time of informed consent.

 
Arm/Group Title Benra 30 mg
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks
All-Cause Mortality
Benra 30 mg
Affected / at Risk (%)
Total   0/121 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Benra 30 mg
Affected / at Risk (%) # Events
Total   1/121 (0.83%)    
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/121 (0.83%)  1
1
Term from vocabulary, MedDRA 20.0
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 3%
Benra 30 mg
Affected / at Risk (%) # Events
Total   45/121 (37.19%)    
Immune system disorders   
Seasonal allergy  1  4/121 (3.31%)  4
Infections and infestations   
Bronchitis  1  4/121 (3.31%)  4
Respiratory tract infection viral  1  4/121 (3.31%)  5
Upper respiratory tract infection  1  10/121 (8.26%)  11
Viral upper respiratory tract infection  1  18/121 (14.88%)  22
Nervous system disorders   
Headache  1  8/121 (6.61%)  8
Respiratory, thoracic and mediastinal disorders   
Asthma  1  10/121 (8.26%)  14
1
Term from vocabulary, MedDRA 20.0
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
Name/Title: Ubaldo Martin, Global Clinical Lead Benralizumab
Organization: AstraZeneca
Phone: +1 301 398 0163
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02918071     History of Changes
Other Study ID Numbers: D3250C00031
First Submitted: September 27, 2016
First Posted: September 28, 2016
Results First Submitted: August 1, 2018
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018