NCT01947946 2013

Methods	Multicentre, randomised, double‐blind, parallel‐group, placebo‐controlled, phase 3 efficacy and safety study
Participants	13 participants with uncontrolled asthma taking medium‐dose ICS plus long‐acting beta2 agonist (LABA) Main inclusion criteria: aged from 18‐75 years, inclusively history of physician‐diagnosed asthma requiring treatment with medium‐dose ICS (> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to first visit Documented treatment with medium‐dose ICS (> 250 μg and ≤ 500 μg fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 month prior to first visit Age mean (SD) years: benralizumab 30 mg every 4 weeks 58.7 (15.70); benralizumab 30 mg every 8 weeks 57.8 (6.38); placebo: 49.6 (6.35) Males n (15): benralizumab 30 mg every 4 weeks 2 (67) benralizumab 30 mg every 8 weeks: 4 (80); placebo: 5 (100) Baseline lung function not reported Allocation: benralizumab 30 mg every 4 weeks 3; benralizumab 30 mg every 8 weeks: 5; placebo: 5
Interventions	Fixed 30 mg dose of benralizumab every 4 weeks or fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter versus placebo
Outcomes	Primary outcomes Asthma exacerbations over planned 48‐week study period Secondary outcomes Not stated
Notes	Study terminated due to sponsor decision after recruitment of 13 participants. No participant completed the study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as randomised but no further details
Allocation concealment (selection bias)	Unclear risk	No details given
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Reported as double blind
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Reported as double blind, but blinding of outcome assessment not specifically described
Incomplete outcome data (attrition bias) All outcomes	High risk	Study terminated due to decision of sponsor after recruitment of 13 participants. No reason given for decision to terminate
Selective reporting (reporting bias)	High risk	Study terminated due to decision of sponsor after recruitment of 13 participants. No reason given for decision to terminate. Original secondary outcomes listed removed from trial registration. Outcomes could not be incorporated into meta‐analysis