GlaxoSmithKline and Innoviva have announced the initiation of a Phase 3 study of a fluticasone furoate/umeclidinium/vilanterol DPI compared to Relvar/Breo Ellipta for the treatment of asthma. GSK recently filed regulatory submissions for the FF/UMEC/VI DPI for the treatment of COPD in the United States and in the European Union.
The Clinical study of Asthma Patients receiving Triple therapy through A single INhaler (CAPTAIN) is expected to enroll a total of 2,250 patients with poorly controlled asthma in 6 treatment arms comparing various dosage strengths.
GSK Head of Respiratory R&D Dave Allen commented, “Despite the availability of treatments, many patients have asthma that is inadequately controlled. 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.”
Innoviva CEO Mike Aguiar said, “Closed triple therapy may provide a new once-a-day treatment option for asthma patients not adequately controlled by existing therapy. If successful, this would further expand the portfolio of respiratory therapy products delivered via the Ellipta inhaler for the treatment of asthma and COPD.”
Read the GSK and Innoviva press release.
