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Benralizumab safety extension in asthma (BORA)
NCT02258542Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2014
- Primary completion
- Oct 2017
- Countries
- 24
- Sponsor
- AstraZeneca
- Modality
- Monoclonal Antibodies
- Drugs
- benralizumab
- Conditions
- asthma
01
Overview
Phase 3, randomised, double-blind trial of benralizumab in asthma (2 arms), sponsored by AstraZeneca. Primary endpoints: Change From Baseline in Basophils at Week 108, Change From Baseline in Leukocytes at Week 108 and 6 more. Started Nov 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Benralizumab Arm A
Benralizumab 30mg SC Q4W
Benralizumab Arm B
Benralizumab 30mg SC Q8W
03
Who it enrols
Patients who completed the double-blind treatment period in a predecessor study (SIROCCO, CALIMA, or ZONDA) on benralizumab or matching placebo.
04
Endpoints
Primary
Change From Baseline in Basophils
Change From Baseline in Leukocytes
Change From Baseline in Lymphocytes
Change From Baseline in Neutrophils
Change From Baseline in Eosinophils
Secondary
Number of Overall Patients With Asthma Exacerbations During Study Period
Change From Baseline in Pre-bronchodilator FEV1
Change From Baseline in Asthma Control Questionnaire
Change From Baseline in Asthma Related and General Health-related Quality of Life Questionnaire
Change of Blood Eosinophil Levels
Change From Baseline in EQ-5D-5L Visual Analog Scale
Work Productivity Loss
Number of Patients Who Had Health Care Encounter
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