The study will investigate the effects of once-daily closed triple combination therapy fluticasone furoate/ umeclidinium/vilanterol compared to therapy with the once-daily dual combination therapy, Relvar/Breo(R) (FF/VI).
Comprising three medicines in fluticasone furoate, umeclidinium, and vilanterol in a closed form, the triple combination will be delivered to patients daily once through GSK’s Ellipta dry powder inhaler.
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.”
Fluticasone furoate is an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA), while vilanterol is a long-acting beta2-adrenergic agonist (LABA).
The combination will undergo a phase III study dubbed, CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler).
The trial's primary endpoint will be the variation from baseline in trough Forced Expiratory volume in 1 second (FEV1) after 24 weeks of treatment.
The main secondary endpoint will be the annualised rate of moderate or severe asthma exacerbations. Other secondary endpoints are assessments of health-related quality of life and control of symptoms.
GSK Respiratory R&D head Dave Allen said: “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.”
The CAPTAIN will be a randomized, double-blinded, active controlled, six-arm parallel group, global multicentre study which will enroll 2,250 patients, with 375 patients assigned randomly to each of the six treatment arms.