GlaxoSmithKline (GSK) and Innoviva have initiated a Phase III Captain study of a triple combination therapy consisting of fluticasone furoate / umeclidinium / vilanterol (FF/UMEC/VI) compared to dual combination therapy of Relvar / Breo (FF/VI) to treat asthma.
Fluticasone furoate is an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol is a long-acting beta-adrenergic agonist (LABA), all three of which are delivered 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.”
The Phase III Clinical study of Asthma Patients receiving Triple therapy through A single Inhaler (CAPTAIN) is being conducted as a randomised, double-blind, active controlled, six-arm parallel group, global multicentre study to evaluate FF/UMEC/VI against FF/VI for treating patients whose asthma is inadequately controlled despite treatment with maintenance asthma medication.
The study is planning to enrol 2,250 patients, out of which 375 will be randomly divided into six treatment arms.
It is primarily focused on determining the baseline change in trough Forced Expiratory volume in one second (FEV1) after completing 24 weeks of treatment.
The secondary endpoint of the trial is to determine the rate of moderate / severe asthma exacerbations on an annual basis. Other secondary endpoints are to evaluate quality of life and symptom control as a result of the triple combination therapy.