20 December 2016 - - UK-based pharmaceutical company GlaxoSmithKline plc (LSE: GSK) (NYSE: GSK) and US-based healthcare-focused asset manager Innoviva, Inc. (NASDAQ: INVA) have started 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 companies said.

The closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2-adrenergic agonist, 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 one second 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.

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 multicenter 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 randomize 2,250 patients, with 375 patients randomly assigned to each of the six treatment arms.

Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 242 m people worldwide. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms.

The causes of asthma are not completely understood but likely involve an interaction between a person's genetic make-up and the environment.

Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

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.

Full US prescribing information, including Boxed Warning and Medication Guide is available at us.gsk.com or US Prescribing Information for Breo Ellipta, EU Prescribing Information for Relvar Ellipta.

Innoviva is focused on bringing compelling new medicines to patients in areas of unmet need by leveraging its significant expertise in the development, commercialisation and financial management of bio-pharmaceuticals.

Innoviva's portfolio is anchored by the respiratory assets partnered with Glaxo Group Ltd., including Relvar/Breollipta and Anoro Ellipta , which were jointly developed by Innoviva and GSK.

Under the agreement with GSK, Innoviva is eligible to receive associated royalty revenues from Relvar / Breollipta, Anoro Ellipta.

In addition, Innoviva retains a 15% economic interest in future payments made by GSK for earlier-stage programs partnered with Theravance Biopharma, Inc., including the closed triple combination therapy for COPD.