Methods | Randomised, double‐blind, parallel‐group, placebo‐controlled trial run over 48 weeks | |
Participants | 1204 participants with symptomatic asthma were randomised to 1 of 3 groups (benralizumab 30 mg 4 weeks, benralizumab 30 mg 8 weeks, or placebo)
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Interventions | SC benralizumab 30 mg/mL every 4 weeks or every 8 weeks versus placebo | |
Outcomes | Primary outcomes
Secondary outcomes
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Notes | Multi‐centre trial in 374 centres from 17 countries Funded by AstraZeneca and Kyowa Hakko Kirin |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Each participant was assigned a unique enrolment number and randomisation code by an interactive web‐based voice response system |
Allocation concealment (selection bias) | Low risk | The identity of the treatment allocation was not made available to the participants, investigators involved in participant treatment or clinical assessment, or study funder |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind (participant, caregiver and investigator) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated, no clarification available from study authors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawal rates were relatively low (10.1%‐12.8%) |
Selective reporting (reporting bias) | Low risk | Unless otherwise specified, all results were presented for participants with baseline blood eosinophilia |