The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol

Eur Respir J. 2013 May;41(5):1017-22. doi: 10.1183/09031936.00087312. Epub 2012 Sep 27.


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 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 multicentre, randomised, double-blind, parallel-group, placebo-controlled trial of 16 000 patients with moderate COPD randomly assigned to once daily treatment with fluticasone furoate/vilanterol (100/25 μg), fluticasone furoate (100 μg), vilanterol (25 μg) or matched placebo; mortality is the primary end-point. The study is an event-driven trial powered by the comparison of furoate/vilanterol versus placebo. Secondary end-points are decline in forced expiratory volume in 1 s and effect on a composite cardiovascular end-point. This article describes the design of the SUMMIT study.

Trial registration: NCT01313676.

Keywords: Cardiovascular disease; chronic obstructive pulmonary disease; mortality.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adult
  • Aged
  • Aged, 80 and over
  • Androstadienes / administration & dosage
  • Benzyl Alcohols / administration & dosage
  • Cardiovascular Diseases / complications
  • Chlorobenzenes / administration & dosage
  • Double-Blind Method
  • Female
  • Forced Expiratory Volume
  • Health Status
  • Humans
  • International Cooperation
  • Male
  • Middle Aged
  • Prognosis
  • Pulmonary Disease, Chronic Obstructive / diagnosis
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / mortality*
  • Time Factors
  • Treatment Outcome


  • Androstadienes
  • Benzyl Alcohols
  • Chlorobenzenes
  • vilanterol
  • fluticasone furoate

Associated data