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. 2022 Jul 12;2022(7):CD010834. doi: 10.1002/14651858.CD010834.pub4

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

  1. Main inclusion/exclusion criteria:

    1. completion of either COLUMBA (NCT01691859) or COSMEX (NCT02135692) study

    2. continuous mepolizumab treatment for ≥ 3 years (no treatment gaps ≥ 12 weeks)

    3. remained on asthma controller medication/therapy

  2. Mean age, years (SD): mepolizumab 100 mg every 4 weeks, 56.6 (11.53); placebo: 55.7 (11.42)

  3. Male, n (%): mepolizumab 100 mg every 4 weeks, 57 (40); placebo, 65 (43)

  4. Baseline mean (SD) prebronchodilator FEV1 % predicted: mepolizumab 100 mg, 61.6 (19.08); placebo, 65.5 (19.64)

  5. Baseline blood eosinophil count, cells / μL,geometric mean (SD): mepolizumab 100 mg, 50 (0.881); placebo, 40 (0.870)

  6. Allocation: mepolizumab, 144; placebo, 151
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

  1. Percentage of participants with 1st clinically significant exacerbation in Part C (primary)

  2. Time to 1st clinically significant exacerbation (requiring systemic corticosteroids, ED visit or hospitalisation)


Secondary

  1. Ratio to baseline in blood eosinophil count in Part C

  2. Percentage of participants with ≥ 0.5 point increase in ACQ‐5 score from baseline in Part C

  3. Time to decrease in asthma control (ACQ‐5 score increase from baseline ≥ 0.5 points)

  4. Percentage of participants with exacerbation requiring ED visit/hospitalisation

  5. Time to first exacerbation requiring ED visit/hospitalisation
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