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RATIONALE: Inhaled corticosteroids have been shown to decrease exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Their effects in patients with milder airflow obstruction remain unclear. OBJECTIVES: This was an analysis of exacerbations in the SUMMIT (Study to Understand Mortality and Morbidity) study. METHODS: In a double-blind, randomized controlled trial, once-daily inhaled placebo, fluticasone furoate (FF; 100 μg), vilanterol (VI; 25 μg), or the combination of FF/VI was administered. The primary outcome was all-cause mortality. Exacerbations of COPD were an additional predefined endpoint. A total of 1,368 centers in 43 countries and 16,485 patients with moderate COPD and heightened cardiovascular risk were included in the study. MEASUREMENTS AND MAIN RESULTS: Compared with placebo, FF/VI reduced the rate of moderate and/or severe exacerbations by 29% (95% confidence interval [CI], 22-35; P 

Original publication




Journal article


Am j respir crit care med

Publication Date





881 - 888


COPD, cardiovascular disease, exacerbations, fluticasone furoate, vilanterol, Administration, Inhalation, Adrenal Cortex Hormones, Aged, Airway Obstruction, Androstadienes, Benzyl Alcohols, Bronchodilator Agents, Chlorobenzenes, Double-Blind Method, Female, Forced Expiratory Volume, Humans, Male, Prospective Studies, Pulmonary Disease, Chronic Obstructive, Treatment Outcome