Study to Assess Functionality, Reliability, and Performance of a Single-Use Auto-Injector With Benralizumab Administered at Home
- Conditions
- Asthma
- Registration Number
- NCT02918071
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to assess functionality, performance, and reliability of an single-use auto-injector (AI) 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
- 121
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home Week 12, Week 16, Week 12 and 16 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.
Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional Week 12, Week 16 AI evaluated as functional is defined as the device having adequately passed the visual inspection and function tests.
Number of AI Devices 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 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.
- Secondary Outcome Measures
Name Time Method The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels Baseline, Week 20, and Week 28 Blood eosinophil counts by timepoint
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 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
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.
Trial Locations
- Locations (1)
Research Site
🇨🇦Quebec, Canada
Research Site🇨🇦Quebec, Canada