GlaxoSmithKline plc (GSK) and Theravance Inc have completed enrollment of approximately 16,000 patients for the Study to Understand Mortality and MorbidITy — known as SUMMIT.
The study’s goal is to determine the impact of GSK’s Breo Ellipta (EU trade name Relvar) on all cause mortality amongst patients with moderate COPD who have cardiovascular disease (CVD) or are at increased risk for CVD, according to a press announcement from GSK and Theravance Inc.
The patients are all randomised to receive either once daily treatment with fluticasone furoate/vilanterol (100/25mcg), fluticasone furoate (100mcg), vilanterol (25mcg), or placebo.
“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,” said Darrell Baker, SVP and Head, Global Respiratory Franchise, GSK.
The primary objective is to evaluate the effect of FF/VI compared with placebo on survival evaluated by the primary endpoint of all-cause mortality.
The secondary endpoints are rate of decline in forced expiratory volume in 1 second (FEV1) and a composite cardiovascular endpoint.
GSK anticipates that each patient will participate in the study for between 16-53 months, but it emphasized that the exact duration of the treatment phase will depend on the mortality rate within the study.
Rick E Winningham, Chief Executive Officer of Theravance added, “There is limited understanding of the relationship between COPD and cardiovascular disease or the potential to affect patient outcomes. 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.”
More information on Breo Ellipta is available on GSK’s website.
