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. 2017 Sep 21;2017(9):CD010834. doi: 10.1002/14651858.CD010834.pub3
Methods Parallel, double‐blind
Participants 496 participants with moderate‐severe asthma (based on at least medium‐dose ICS, inadequate control ACQ ≥ 1.5)
  1. Main inclusion/exclusion criteria:

    1. ACQ‐7 score ≥ 1.5

    2. maintenance treatment with medium‐dose ICS; maintenance OCS not allowed

  2. Age: reslizumab, mean 44.9; placebo, mean 45.1

  3. Males: reslizumab, 137; placebo, 44

  4. Baseline mean (SD) FEV1, % predicted: reslizumab, 66.8% placebo, 66.5%

  5. Allocation: to reslizumab, 398; to placebo, 98

Interventions IV reslizumab 3.0 mg/kg or placebo once every 4 weeks (total of 4 doses)
Outcomes Primary outcomes
  1. HRQoL (as measured by a validated questionnaire)

  2. Asthma exacerbation as defined by a hospital admission or treatment with oral corticosteroids

  3. Serious adverse events.


Secondary outcomes
  1. FEV1

  2. PEFR

  3. Asthma symptoms

  4. Adverse events/side effects

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

Notes 66 study locations across the USA
Funding: Teva Branded Pharmaceutical Products R&D, Inc
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated, no clarification available from study authors
Allocation concealment (selection bias) Unclear risk Not stated, no clarification available from study authors
Blinding of participants and personnel (performance bias) All outcomes Low risk Double blind
Blinding of outcome assessment (detection bias) All outcomes Low risk Double blind
Incomplete outcome data (attrition bias) All outcomes Low risk Dropouts comparable in each group (16/98, 16%, placebo vs 58/398, 15%, reslizumab)
Selective reporting (reporting bias) Low risk All primary and secondary outcomes reported with numbers, except blood eosinophil counts only shown as a chart