Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home
- Conditions
- Asthma
- Interventions
- Biological: Benralizumab
- Registration Number
- NCT02417961
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to assess functionality, performance, and reliability of an accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Benralizumab 30 mg Benralizumab Benralizumab administered subcutaneously every 4 weeks
- Primary Outcome Measures
Name Time Method Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home Week 12, Week 16, and Weeks 12 and 16 Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection and function tests. The percentage is calculated among all patients/caregivers who had been deemed by the Principal Investigator to be suitable for at home administration and were still in the study at the time point.
Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints) Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16 Number (%) of APFS used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on APFS dispensed and used for the specified time point.
Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional Week 12, Week 16 Number (%) of returned APFS used to administer benralizumab at home that have been evaluated as functional among all returned APFS used to administer benralizumab at home. A functional APFS is defined as an answer of "Yes" to all the questions in the visual inspection and function tests. The percentage is calculated among all returned APFS at the specified time point.
- Secondary Outcome Measures
Name Time Method The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA) Baseline until Week 28 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
The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score Week 0 (baseline) and weeks 4, 8, 12, 16, 20 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.
The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab Baseline, Week 8, Week 20, and Week 28 Mean PK Concentration at each visit
The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels Baseline, Week 20, and Week 28 Blood eosinophil counts by timepoint
Trial Locations
- Locations (1)
Research Site
🇨🇦Quebec, Canada