Harrison 2020.
Study characteristics | ||
Methods | Multicentre, randomised, double‐blind, parallel‐group, placebo‐controlled, phase 3b study | |
Participants | 656 participants aged 18‐75 with severe eosinophilic asthma
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Interventions | Benralizumab SC every 8 weeks at 30 mg (1st 3 doses given 4 weeks apart) for 24 weeks vs matched placebo. Patients were randomised 2:1 intervention to placebo | |
Outcomes | Primary
Secondary
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Notes | Study conducted from July 2017‐September 2019 at 221 research centres across Europe and North America. Supported by AstraZeneca. NCT03170271 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed by a web‐based system. |
Allocation concealment (selection bias) | Low risk | Treatment group assignment as well as kit allocation was performed by a web‐based system. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Reported as: "...eosinophil, basophil, and monocyte counts were removed from any central laboratory reports sent to investigative sites to prevent unintentional unblinding of treatment allocation post‐dose.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 92.3% of participants completed intervention, and 95.2% of participants completed placebo |
Selective reporting (reporting bias) | Low risk | No evidence of reporting bias |