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

Park 2016.

Study characteristics
Methods Parallel
Participants 103: 38 male (age 53.2, 55.6, 51.4, 50.8)
Moderate/severe (based on ICS dose (medium/high), exacerbation history, and ACQ ≥ 1.5 on at least 2 occasions) participants also had to demonstrate post‐bronchodilator FEV1 reversibility ≥ 12% and ≥ 200 mL, or a positive response to methacholine challenge (PC20 ≤ 8 mg/mL)

  1. Main inclusion/exclusion criteria:

    1. 2‐6 exacerbations in the previous 12 months

    2. ACQ‐6 score ≥ 1.5 at least twice during screening

    3. morning pre‐bronchodilator FEV1 40%‐90%

    4. maintenance treatment with medium‐ to high‐dose ICS in combination with LABA for ≥ 12 months

  2. Mean age, years (SD): benralizumab 2 mg, 53 (11.3); benralizumab 20 mg, 56 (8.9); benralizumab 100 mg, 51 (13.8); placebo, 51 (11.8)

  3. Male, n (%): benralizumab 2 mg, 13 (50); benralizumab 20 mg, 6 (24); benralizumab 100 mg, 10 (39); placebo, 9 (35)

  4. Baseline mean (SD) FEV1 % predicted: benralizumab 2 mg, 65 (14.1); benralizumab 20 mg, 71 (13.2); benralizumab 100 mg, 68 (15.8); placebo, 69 (16.3)

  5. Allocation: benralizumab 2 mg, 26; benralizumab 20 mg, 25; benralizumab 100 mg, 26; placebo, 26
Interventions SC doses given at weeks 1, 4, 8, 16, 24, 32, 40. Benralizumab 2 mg, 20 mg or 100 mg SC
Outcomes Primary outcomes

  1. Annual exacerbation rate


Secondary outcomes

  1. Lung function

  2. ACQ‐6

  3. FeNO


Exploratory endpoints included blood eosinophil counts.
Notes 32 sites in South Korea and Japan
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Eosinophilic participants were randomised using a central, interactive web‐response system
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 The study medication was administered … in a blinded fashion
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated, no clarification available from study authors
Incomplete outcome data (attrition bias)
All outcomes Low risk Attrition rates relatively high but even across groups (19.2% for placebo vs 16.0%‐23.1% for treatment groups)
Selective reporting (reporting bias) Low risk All outcomes reported