Effect of Fluticasone Furoate and Vilanterol on Exacerbations of COPD in Patients with Moderate Airflow Obstruction

SUMMIT Investigators, Fernando J Martinez, Jørgen Vestbo, Julie A Anderson, Robert D Brook, Bartolome R Celli, Nicholas J Cowans, Courtney Crim, Mark Dransfield, Sally Kilbride, Julie Yates, David E Newby, Dennis Niewoehner, Peter Ma Calverley

Research output: Contribution to journalArticlepeer-review


BACKGROUND: Inhaled corticosteroids have been shown to decrease exacerbations in COPD patients with moderate to severe COPD. Their effect in patients with milder airflow obstruction remains unclear.

OBJECTIVE: This was an analysis of exacerbations in the Study to Understand Mortality and MorbidITy (SUMMIT) study.

DESIGN: In a double-blind randomized controlled trial, once daily inhaled placebo, fluticasone furoate (FF, 100 μg), vilanterol (VI, 25 μg) or the combination (FF/VI) was administered. The primary outcome was all-cause mortality. Exacerbations of COPD were an additional pre-defined endpoint.

SETTING: 1,368 centers in 43 countries.

PARTICIPANTS: 16,485 patients with moderate COPD and heightened cardiovascular risk.

RESULTS: Compared with placebo, FF/VI reduced the rate of moderate/severe exacerbations by 29% (95% CI 22, 35; p<0.001) and the rate of hospitalized exacerbations by 27 % (95% CI 13, 39; p<0.001). These relative effects were similar regardless of whether subjects had a history of exacerbation in the year prior to the study or an FEV1 less than or ≥ 60% predicted. The number needed to treat was not influenced by baseline FEV1 but was influenced by the prior history of exacerbations. FF/VI also reduced the rate of exacerbations treated with corticosteroids alone or with corticosteroids and antibiotics but not those treated with antibiotics alone.

CONCLUSIONS: Patients with moderate chronic airflow obstruction experienced a reduction in exacerbations with FF/VI, compared with placebo, irrespective of a prior history of exacerbations or baseline FEV1. Clinical trial registration available at www.clinicaltrials.gov, ID NCT01313676.

Original languageEnglish
JournalAmerican Journal of Respiratory and Critical Care Medicine
Publication statusPublished - 21 Oct 2016


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