title: 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 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.
authors.affiliation: Dept of Respiratory Medicine J, Odense University Hospital and University of Southern Denmark, Odense, Denmark. jvestbo@dadlnet.dk
authors.forename: Jørgen
authors.initials: J
authors.lastname: Vestbo
authors.forename: Julie
authors.initials: J
authors.lastname: Anderson
authors.forename: Robert D
authors.initials: RD
authors.lastname: Brook
authors.forename: Peter M A
authors.initials: PM
authors.lastname: Calverley
authors.forename: Bartolome R
authors.initials: BR
authors.lastname: Celli
authors.forename: Courtney
authors.initials: C
authors.lastname: Crim
authors.forename: Brett
authors.initials: B
authors.lastname: Haumann
authors.forename: Fernando J
authors.initials: FJ
authors.lastname: Martinez
authors.forename: Julie
authors.initials: J
authors.lastname: Yates
authors.forename: David E
authors.initials: DE
authors.lastname: Newby
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage; D001592:Benzyl Alcohols / Q000008:administration & dosage; D002318:Cardiovascular Diseases / Q000150:complications; D002722:Chlorobenzenes / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006304:Health Status; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D001592:Benzyl Alcohols; D002722:Chlorobenzenes; C550468:vilanterol; C523187:fluticasone furoate