Castro 2014a.
Study characteristics | ||
Methods | Double‐blind, dose‐ranging RCT | |
Participants | 606 participants with uncontrolled asthma randomised and 535 completed
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Interventions | 6 arms: benralizumab 2 mg or benralizumab 20 mg or benralizumab 100 mg or placebo delivered by 2 SC injections every 4 weeks for the first 3 doses (weeks 1, 4, and 8), then every 8 weeks (weeks 16, 24, 32, and 40) | |
Outcomes | Primary outcomes
Secondary outcomes in eosinophilic individuals
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Notes | 52‐week multi‐national study with sites in 10 countries. The study protocol was developed by MedImmune and the corresponding author. The investigators collected and had full access to all study data, which were analysed by the funding source. The analysis was done solely by MedImmune; however, study authors helped determine which analyses were done and could request further ad‐hoc analyses. The report was written by the study authors with a medical writer funded by the funding source. The corresponding author had final responsibility for decision to submit for publication. Funding: MedImmune |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Interactive web/voice‐response system for random assignment |
Allocation concealment (selection bias) | Low risk | Allocation concealment was ensured by the vendor systems and no study personnel or site had access to the system. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants, treating physicians, study investigators, and study statisticians were masked to treatment allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The withdrawal rates were even across groups. |
Selective reporting (reporting bias) | Low risk | Results for most but not all listed primary and secondary outcomes were reported (e.g. symptoms score, AQLQ – shown in supplementary material in graphs only) |