Methods | Randomised, double‐blind, double‐dummy, phase 3 study | |
Participants | 576 participants with recurrent asthma exacerbations and evidence of eosinophilic inflammation despite high doses of inhaled glucocorticoids to 1 of 3 study groups
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Interventions | Mepolizumab in a 75 mg intravenous dose versus mepolizumab in a 100 mg subcutaneous dose versus placebo every 4 weeks for 32 weeks | |
Outcomes | Primary outcomes
Secondary outcomes:
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Notes | 32‐week treatment intervention, with 1‐6 weeks run‐in and 8‐week follow‐up. Conducted in Baltimore, Middlesex, Ghent, Vancouver, Parma, Marseille and Paris Funding: GlaxoSmithKline |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Centralised computer‐generated permuted block schedule |
Allocation concealment (selection bias) | Low risk | Treatment allocations will be concealed via the RandAll system |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Mepolizumab and placebo were identical in appearance and were administered by a staff member who was unaware of the study group assignments. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The study drugs were prepared by staff members who were aware of the study group assignments but were not involved in study assessments. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 6% (placebo), 8% (IV), 5% ( SC) did not complete the study |
Selective reporting (reporting bias) | Low risk | All outcome measures reported |