GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that they launched a phase III trial evaluating the triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with asthma.
The companies’ triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatment is delivered once a day using GSK’s Ellipta dry powder inhaler.
The phase III Captain study will evaluate the change in trough forced expiratory volume in 1 second at 24 weeks, as well as the annual rates of moderate or severe asthma exacerbations. Researchers will compare the triple combination therapy with the dual Relvar/Breo (FF/VI) treatment.
“Despite the availability of treatments, many patients have asthma that is inadequately controlled,” head of respiratory R&D Dave Allen said in prepared remarks. “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.”
“Closed triple therapy may provide a new once-a-day treatment option for asthma patients not adequately controlled by existing therapy,” Innoviva CEO Mike Aguiar added. “If successful, this would further expand the portfolio of respiratory therapy products delivered via the Ellipta inhaler for the treatment of asthma and COPD.”