Phase 3 Study Begins on Triple-combo Therapy for Asthma

GlaxoSmithKline and Innoviva Inc have initiated a phase III study investigating the effects of once-daily closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) as a treatment for patients with asthma. The product will be compared to therapy with the once-daily dual combination therapy, Relvar/Breo (FF/VI).

The closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta₂-adrenergic agonist (LABA), delivered once-daily in GSK’s Ellipta dry powder inhaler.

In the phase III study, termed CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler), the primary endpoint is the change from baseline in trough FEV₁ at 24 weeks of treatment and the key secondary endpoint is the annualized rate of moderate/severe asthma exacerbations. Other secondary endpoints are assessing health-related quality of life and symptom control.

Dave Allen, Head of Respiratory R&D at GSK, 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.”