The study to understand mortality and morbidity in COPD (SUMMIT) study protocol

Abstract

Chronic obstructive pulmonary disease (COPD) often coexists with other chronic diseases and comorbidities that can markedly influence patients' health status and prognosis. This is particularly true for cardiovascular disease (CVD). However, there have been no trials assessing the effect of COPD medications on CVD in patients with both diseases.

The “Study to Understand Mortality and MorbidITy in COPD” (SUMMIT) aims at determining the impact of Fluticasone Furoate/Vilanterol combination (FF/VI), and the individual components on the survival of patients with moderate COPD and either a history of CVD or at increased risk for CVD.

SUMMIT is a multi-center, randomised, double-blind, parallel-group, placebo-controlled trial of 16,000 patients with moderate COPD randomly assigned to once daily treatment with FF/VI (100/25 ;mcg), Fluticasone Furoate (100 ;mcg), Vilanterol (25 ;mcg) or matched placebo; mortality is the primary endpoint. The study is an event-driven trial powered on the comparison of FF/VI vs. placebo. Secondary endpoints are decline in forced expiratory volume in 1 second (FEV1) and effect on a composite cardiovascular endpoint. This manuscript describes the design of the SUMMIT study.