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

Castro 2015a.

Study characteristics
Methods Double‐blind, placebo‐controlled, parallel‐group study
Participants 489 participants with moderate‐severe asthma (medium dose of ICS, inadequate control ACQ ≥ 1.5, and at least 1 exacerbation in the past 12 months)
  1. Main inclusion/exclusion criteria:

    1. blood eosinophils ≥ 400 cells/μL during 2 to 4‐week screening period

    2. ACQ‐7 score ≥ 1.5

    3. maintenance treatment with medium‐dose ICS (i.e. ≥ 440 μg/d FP or equivalent daily); ± additional controller or maintenance OCS

  2. Mean age, years (IQR): reslizumab, 48 (38‐57); placebo, 49 (38‐57)

  3. Male, n (%): reslizumab, 103 (42); placebo, 83 (34)

  4. Baseline mean FEV1 % predicted: reslizumab, 64; placebo, 65

  5. 245 allocated to reslizumab, 244 to placebo

Interventions IV infusion of reslizumab 3 mg/kg or matching placebo every 4 weeks (13 doses with last dose in week 48)
Outcomes Primary outcomes (per protocol)
  1. HRQoL (as measured by a validated questionnaire)

  2. Asthma exacerbation as defined by a hospital admission or treatment OCS

  3. Serious adverse events


Secondary outcomes (per protocol)
  1. Measures of lung function: FEV1, PEFR

  2. Asthma symptoms

  3. Adverse events/side effects

  4. Eosinophil counts in peripheral blood, sputum or bronchioalveolar lavage fluid

Notes 128 clinical research centres. The research was funded by Teva Branded Pharmaceutical Products R&D. Teva employees were involved in the study design, data collection and analysis, and in the writing of this manuscript. All study authors had full access to all study data and had final responsibility for the decision to submit for publication.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was done with use of interactive response technology with computerised central randomisation.
Allocation concealment (selection bias) Low risk The funder’s clinical personnel involved in the study were also masked to the study drug identity until the database was locked for analysis and the treatment assignment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants and investigators remained masked to treatment assignment during the study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Participants and investigators remained masked to treatment assignment during the study
Incomplete outcome data (attrition bias)
All outcomes Low risk The withdrawal rates were relatively low and even across the groups (11%‐14%)
Selective reporting (reporting bias) Low risk All primary and secondary outcome measures were reported.