Randomised clinical trial to investigate efficacy and safety of benralizumab 30 mg SC as an add-on therapy in uncontrolled eosinophilic asthma patients treated with medium-dose ICS-LABA compared to conventional escalation to high-dose ICS-LABA treatment - BRISOTE

Inclusion Criteria

• - Written informed consent
• - Participant must be 12 to 75 years of age
• - Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit (V) 1.
• - Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids).
• - Weight of ≥ 35 kg.
• - Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted
• - Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent.
• - ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3.
• - Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol.
• - Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol.
• - At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary.