Abstract | BACKGROUND: Evidence for the management of chronic obstructive pulmonary disease ( COPD) comes from closely monitored efficacy trials involving groups of patients who were selected on the basis of restricted entry criteria. There is a need for randomized trials to be conducted in conditions that are closer to usual clinical practice. METHODS: In a controlled effectiveness trial conducted in 75 general practices, we randomly assigned 2799 patients with COPD to a once-daily inhaled combination of fluticasone furoate at a dose of 100 μg and vilanterol at a dose of 25 μg (the fluticasone furoate- vilanterol group) or to usual care (the usual-care group). The primary outcome was the rate of moderate or severe exacerbations among patients who had had an exacerbation within 1 year before the trial. Secondary outcomes were the rates of primary care contact (contact with a general practitioner, nurse, or other health care professional) and secondary care contact (inpatient admission, outpatient visit with a specialist, or visit to the emergency department), modification of the initial trial treatment for COPD, and the rate of exacerbations among patients who had had an exacerbation within 3 years before the trial, as assessed in a time-to-event analysis. RESULTS: The rate of moderate or severe exacerbations was significantly lower, by 8.4% (95% confidence interval, 1.1 to 15.2), with fluticasone furoate- vilanterol therapy than with usual care (P=0.02). There was no significant difference in the annual rate of COPD-related contacts to primary or secondary care. There were no significant between-group differences in the rates of the first moderate or severe exacerbation and the first severe exacerbation in the time-to-event analyses. There were no excess serious adverse events of pneumonia in the fluticasone furoate- vilanterol group. The numbers of other serious adverse events were similar in the two groups. CONCLUSIONS: In patients with COPD and a history of exacerbations, a once-daily treatment regimen of combined fluticasone furoate and vilanterol was associated with a lower rate of exacerbations than usual care, without a greater risk of serious adverse events. (Funded by GlaxoSmithKline; Salford Lung Study ClinicalTrials.gov number, NCT01551758 .).
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Authors | Jørgen Vestbo, David Leather, Nawar Diar Bakerly, John New, J Martin Gibson, Sheila McCorkindale, Susan Collier, Jodie Crawford, Lucy Frith, Catherine Harvey, Henrik Svedsater, Ashley Woodcock, Salford Lung Study Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 375
Issue 13
Pg. 1253-60
(09 29 2016)
ISSN: 1533-4406 [Electronic] United States |
PMID | 27593504
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Androstadienes
- Benzyl Alcohols
- Chlorobenzenes
- Drug Combinations
- Glucocorticoids
- vilanterol
- fluticasone furoate
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Topics |
- Administration, Inhalation
- Aged
- Androstadienes
(administration & dosage, adverse effects)
- Benzyl Alcohols
(administration & dosage, adverse effects)
- Chlorobenzenes
(administration & dosage, adverse effects)
- Drug Combinations
- Female
- Glucocorticoids
(administration & dosage, adverse effects)
- Humans
- Male
- Middle Aged
- Pneumonia
(etiology)
- Pulmonary Disease, Chronic Obstructive
(drug therapy)
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