Study to Understand Mortality and MorbidITy - SUMMIT


The goal of the trial was to evaluate treatment with a corticosteroid and long-acting β agonist among patients with chronic obstructive pulmonary disease (COPD) and increased cardiovascular risk.

Contribution to the Literature: The SUMMIT trial failed to show that a corticosteroid and long-acting β agonist improved survival in moderate COPD.

Study Design

  • Randomized
  • Parallel
  • Placebo

Patients with moderate COPD were randomized to fluticasone furoate (100 μg) (n = 4,157), vilanterol (25 μg) (n = 4,140), the combination of fluticasone furoate and vilanterol (n = 4,140), or placebo (n = 4,131).

  • Total number of enrollees: 16,568
  • Duration of follow-up: maximum 4 years, median 1.8 years
  • Mean patient age: 65 years
  • Percentage female: 25%
  • Percentage diabetics: 27%

Inclusion criteria:

  • Patients 40-80 years of age with moderate COPD
  • Forced expiratory volume in 1 second (FEV1) 50-70%, FEV1/forced vital capacity (FVC) ≤0.7, smoking history ≥10 pack-years, and score ≥2 on modified Medical Research Council dyspnea scale
  • History of, or increased risk of, cardiovascular disease

Exclusion criteria:

  • Respiratory disorders other than COPD
  • Lung reduction surgery
  • Use of long-term oxygen or oral corticosteroid therapy
  • Severe heart failure (New York Heart Association class IV or ejection fraction <30%)
  • Life expectancy <3 years
  • End-stage chronic renal disease

Principal Findings:

The primary outcome, incidence of all-cause mortality, occurred in 6.1% of the fluticasone furoate group (p = 0.28 vs. placebo), 6.4% of the vilanterol group (p = 0.66 vs. placebo), 6.0% of the combination fluticasone and vilanterol group (p = 0.14 vs. placebo), and 6.7% with placebo.

Secondary outcomes:

  • FEV1 decline: 38 ml per year in the fluticasone furoate group (p = 0.026 vs. placebo), 47 ml per year in the vilanterol group (p = 0.65), 38 ml per year in the combination treatment group (p = 0.019), and 46 ml per year in the placebo group
  • Percent reduction in moderate and severe exacerbations: 12% for the fluticasone furoate group (p = 0.004 vs. placebo), 10% for the vilanterol group (p = 0.017 vs. placebo), and 29% for the combination group (p < 0.0001 vs. placebo)


Among patients with moderate COPD, fluticasone furoate (alone or in combination with vilanterol) was associated with a reduction in the rate of decline in FEV1 and a reduction in moderate and severe exacerbations. Despite a study cohort enriched for cardiovascular risk, none of the study medications was associated with a reduction in mortality.


Vestbo J, Anderson JA, Brook RD, et al., on behalf of the SUMMIT Investigators. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet 2016;387:1817-26.

Clinical Topics: Prevention, Smoking

Keywords: Cardiovascular Diseases, Forced Expiratory Volume, Ischemia, Mortality, Pulmonary Disease, Chronic Obstructive, Risk Factors, Secondary Prevention, Smoking, Treatment Outcome, Vital Capacity

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