Respiratory drug meets primary endpoint in CAPTAIN trial

GlaxoSmithKline and Innoviva’s drug Trelegy Ellipta, a once-daily single inhaler triple therapy consisting of fluticasone furoate (an inhaled corticosteroid), umeclidiniumand (a long-acting muscarinic antagonist) and vilanterol (a long-acting beta agonist) has met primary endpoint in the phase III CAPTAIN study. The CAPTAIN trial involved 2,436 patients and assessed fluticasone furoate, umeclidiniumand and vilanterol versus Relvar/Breo Ellipta (FF/VI) given once-daily to patients whose asthma is inadequately controlled despite treatment with ICS/LABA maintenance asthma medication. There was a statistically significant 110mL improvement in lung function for FF/UMEC/VI 100/62.5/25mcg versus Relvar/Breo 100/25mcg and a statistically significant 92mL improvement in trough FEV1 for FF/UMEC/VI 200/62.5/25mcg versus Relvar/Breo 200/25mcg.
Dr Hal Barron, GSK chief scientific officer and R&D president, said: “We believe a once-daily single inhaler triple therapy that improves lung function is an advance for patients with uncontrolled asthma since this option is not currently available. We plan to submit these data for regulatory review after the full dataset is available.”