GlaxoSmithKline (GSK) and Theravance have announced the completion of patient enrolment in the SUMMIT trial designed to determine the impact of Relvar/Breo Ellipta (fluticasone furoate’FF’/vilanterol ‘VI’) in patients with moderate chronic obstructive pulmonary disease (COPD) who have cardiovascular disease (CVD) or are at increased risk for CVD.
Around 16,000 patients enrolled in the multicentre, double-blind, parallel-group, placebo-controlled SUMMIT (‘Study to Understand Mortality and MorbidITy’) trial.
The trial includes patients with moderate COPD and a history of or increased risk for cardiovascular disease who are randomised to receive either once daily treatment with fluticasone furoate/vilanterol (100/25mcg), fluticasone furoate (100mcg), vilanterol (25mcg) or placebo.
The primary objective of the trial is to assess the effect of FF/VI compared with placebo on survival evaluated by the primary endpoint of all-cause mortality, while the secondary endpoints are rate of decline in forced expiratory volume in 1 second (FEV) and a composite cardiovascular endpoint.
The company said that the exact duration of the treatment phase will depend on the mortality rate within the trial and it is expected that each patient will participate in the trial for between 16-53 months.
GSK SVP and head of global respiratory Franchise Darrell Baker said: "We hope that results from this study will increase our understanding of cardiovascular comorbidity in COPD, and of the effects of Relvar/Breo Ellipta when used to manage COPD."
In May 2013, the US Food and Drug Administration (FDA) had granted license to Breo Ellipta (FF/VI 100/25mcg) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
The company said that Breo Ellipta is not indicated for the relief of acute bronchospasm or the treatment of asthma in the US.
Theravance chief executive officer Rick Winningham said: "We believe that, once available, the results from this landmark study will enhance our knowledge of these co-morbid conditions and provide important information about treatment with Relvar/Breo in a COPD population with cardiovascular risk factors."