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The study to understand mortality and morbidity in COPD (SUMMIT) study protocol.
MedLine Citation:
PMID:  23018908     Owner:  NLM     Status:  Publisher    
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.
Jørgen Vestbo; Julie Anderson; Robert D Brook; Peter Ma Calverley; Bartolome R Celli; Courtney Crim; Brett Haumann; Fernando Martinez; Julie Yates; David E Newby
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-27
Journal Detail:
Title:  The European respiratory journal : official journal of the European Society for Clinical Respiratory Physiology     Volume:  -     ISSN:  1399-3003     ISO Abbreviation:  Eur. Respir. J.     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8803460     Medline TA:  Eur Respir J     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Odense University Hospital and University of Southern Denmark, Odense, Denmark.
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