NCT01947946.
Study characteristics | ||
Methods | Multicentre, randomised, double‐blind, parallel‐group, placebo‐controlled, phase 3 efficacy and safety study | |
Participants | 13 participants with uncontrolled asthma taking medium‐dose ICS plus LABA
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Interventions | Fixed 30 mg dose of benralizumab every 4 weeks or fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter versus placebo | |
Outcomes | Primary outcomes
Secondary outcomes
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Notes | Study terminated due to sponsor decision after recruitment of 13 participants. No participant completed the study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised but no further details |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Reported as double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Reported as double‐blind, but blinding of outcome assessment not specifically described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Study terminated due to decision of sponsor after recruitment of 13 participants. No reason given for decision to terminate |
Selective reporting (reporting bias) | High risk | Study terminated due to decision of sponsor after recruitment of 13 participants. No reason given for decision to terminate. Original secondary outcomes listed removed from study registration. Outcomes could not be incorporated into meta‐analysis |