GlaxoSmithKline and Innoviva commence trial of new asthma drug

GlaxoSmithKline and Innoviva have announced the commencement of a new phase III clinical trial of a promising asthma therapy.

The partners are launching the study to assess the safety and efficacy of a once-daily closed triple combination therapy consisting of fluticasone furoate, umeclidinium and vilanterol (FF/UMEC/VI) compared to the once-daily dual combination therapy Relvar/Breo.

In this new phase III trial, entitled CAPTAIN, the primary endpoint will be a change from baseline in trough forced expiratory volume in one second after 24 weeks of treatment, while secondary endpoints include asthma exacerbation rates, health-related quality of life and symptom control.

The study aims to randomise 2,250 patients, with 375 patients randomly assigned to each of the six treatment arms. The established comparator therapy, Relvar/Breo Ellipta, combines fluticasone furoate and vilanterol in a single inhaler called the Ellipta.

Dave Allen, head of respiratory research and development at GlaxoSmithKline, said: "While some patients already receive triple therapy in two or more inhalers, we believe there will be real benefits from delivering the dual bronchodilators together with their inhaled steroid once a day in a single inhalation."

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