Moore 2022.
Study characteristics | ||
Methods | Multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group study | |
Participants | 195 adults with severe eosinophilic asthma who had previous long‐term treatment with mepolizumab
|
|
Interventions | Mepolizumab SC 100 mg every 4 weeks for 52 weeks vs placebo (but can switch to open‐label mepolizumab after a severe exacerbation). Placebo is discontinuation from previous mepolizumab treatment | |
Outcomes | Primary
Secondary
|
|
Notes | Study conducted from January 2016‐July 2019 at 75 centres in 14 countries Supported by GlaxoSmithKline. NCT02555371 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed by an interactive response technology system. |
Allocation concealment (selection bias) | Low risk | Reported as: "[Treatement] will be administered by a designated blinded member of the site staff. Once prepared, mepolizumab and placebo will be identical in appearance." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Reported as: "The blinding of all those involved in the evaluation of the study treatment (e.g. physician/nurse as well as the subject) shall be maintained at all times." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Reported as: "The blinding of all those involved in the evaluation of the study treatment (e.g. physician/nurse as well as the subject) shall be maintained at all times." Biomarker results will be masked to outcome assessors to protect unblinding. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only 41% of the placebo group and 67% of the intervention group finished the randomised study. |
Selective reporting (reporting bias) | Low risk | All outcomes reported |