Quebec

Researchers are evaluating the effectiveness and safety of benralizumab as an additional treatment for people aged 12 to 75 with uncontrolled eosinophilic asthma who are already using medium-dose inhaled corticosteroids combined with long-acting beta2-agonists (ICS-LABA). The study compares this approach to the usual care of increasing inhaled therapy to high-dose ICS-LABA. This is a global, phase 3b, randomized, double-blind, active-controlled trial involving participants with a history of eosinophilic asthma. Participants receive either benralizumab 30 mg by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks, alongside their medium-dose ICS-LABA treatment, or they receive a placebo injection with an increased high-dose ICS-LABA treatment. The study includes a run-in period to monitor compliance with usual asthma treatment and aims to assess adding benralizumab versus stepping up inhaled therapy. During the study, researchers monitor asthma control, lung function, and exacerbations over 48 weeks. Participants complete asthma diaries to track medication adherence and symptoms. The main outcome measured is the annual rate of asthma exacerbations. Safety and adverse events are also closely followed throughout the study period.