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

Harrison 2020.

Study characteristics
Methods Multicentre, randomised, double‐blind, parallel‐group, placebo‐controlled, phase 3b study
Participants 656 participants aged 18‐75 with severe eosinophilic asthma

  1. Main inclusion/exclusion criteria:

    1. history of physician‐diagnosed asthma requiring treatment

    2. history of at least 2 asthma exacerbations in previous 12 months, despite treatment with medium‐dose to high‐dose ICS plus another asthma controller

    3. use of a high‐dose ICS plus another asthma controller for 3 months prior to enrolment

    4. ACQ‐6 of at least 1.5 at screening

    5. Blood eosinophils of at least 300 cells/µL (or at least 150 with at least 1 of the following: maintenance OCS use at study entry, history of nasal polyposis, ≥ 3 exacerbations in the previous year, FVC of < 65% predicted, or ≥ 18 years at asthma diagnosis)

    6. Documented prebronchodilator FEV1 < 80%, ACQ‐6 of at least 1.5, FEV1 ≥ 12%, and PEF variability ≥ 10%

  2. Exclusion: other pulmonary disease or disorder, alcohol abuse, current malignancy

  3. Age mean, years (SD): benralizumab 30 mg, 52.5 (12.7); placebo, 53.3 (12.5)

  4. Male, n (%): benralizumab 30 mg, 164 (38%); placebo, 93 (41%)

  5. Baseline mean (SD) prebronchodilator FEV1 % predicted: benralizumab 30 mg, 54 (14.2); placebo, 55.9 (13.6)

  6. Baseline mean (SD) post‐bronchodilator FEV1 % of predicted: benralizumab 30 mg, 68 (16.44); placebo, 68.6 (15.24)

  7. Blood eosinophil count, median (range): benralizumab 30 mg, 390 (40‐7970); placebo, 390 (20‐5600)
Interventions Benralizumab SC every 8 weeks at 30 mg (1st 3 doses given 4 weeks apart) for 24 weeks vs matched placebo. Patients were randomised 2:1 intervention to placebo
Outcomes Primary

  1. Annualised exacerbation rate


Secondary

  1. Time to first asthma exacerbation

  2. Mean change from baseline of SGRQ score

  3. Mean weekly PEF change from baseline

  4. FEV1 % predicted

  5. ACQ‐6
Notes Study conducted from July 2017‐September 2019 at 221 research centres across Europe and North America.
Supported by AstraZeneca. NCT03170271
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was performed by a web‐based system.
Allocation concealment (selection bias) Low risk Treatment group assignment as well as kit allocation was performed by a web‐based system.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Reported as: "...eosinophil, basophil, and monocyte counts were removed from any central laboratory reports sent to investigative sites to prevent unintentional unblinding of treatment allocation post‐dose.”
Incomplete outcome data (attrition bias)
All outcomes Low risk 92.3% of participants completed intervention, and 95.2% of participants completed placebo
Selective reporting (reporting bias) Low risk No evidence of reporting bias