GlaxoSmithKline plc (GSK) and Innoviva, Inc. announced the start of a phase III study investigating the effects of once-daily closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) when compared to therapy with the once-daily dual combination therapy, Relvar/Breo (FF/VI), as a treatment for patients with asthma.
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 Forced Expiratory volume in 1 second (FEV1) at 24 weeks of treatment and the key secondary endpoint is the annualised 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.”
Mike Aguiar, CEO of Innoviva, Inc., added, “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.”
CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) is a superiority study to demonstrate the add-on benefit of UMEC at two dosage strengths of 62.5 mcg and 31.25 mcg in a single inhaler when compared to FF/VI. It is a randomised, double-blind, active controlled, six-arm parallel group, global multicentre study evaluating FF/UMEC/VI (100/31.25/25, 100/62.5/25, 200/31.25/25 and 200/62.5/25 micrograms) versus FF/VI (100/25 and 200/25 micrograms) given once daily in the morning to patients whose asthma is inadequately controlled despite treatment with maintenance asthma medication. The study aims to randomise 2,250 patients, with 375 patients randomly assigned to each of the six treatment arms
Relvar/Breo Ellipta is a once-daily dual combination treatment comprising fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting beta2-agonist, in a single inhaler, the Ellipta.
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