Abstract
Background. Evidence for the management of chronic obstructive pulmonary disease (COPD) comes from closely monitored efficacy trials on patient groups selected on restricted entry criteria. There is a need for randomized trials closer to usual clinical practice.
Methods. In a randomized, controlled effectiveness trial, 2,799 patients with a general practitioner’s diagnosis of COPD were initiated on once-daily inhaled combination of 100 μg fluticasone furoate and 25 μg vilanterol (FF/VI) or usual care. The primary outcome was moderate-severe exacerbations in patients who had an exacerbation within 1 year before the study. Secondary outcomes were primary and secondary care contacts, modification to initial study COPD treatment, and time to exacerbations in patients who had an exacerbation within 3 years before the study.
Results. Compared with usual care, the rate of moderate-severe exacerbations was significantly reduced by FF/VI therapy, percent reduction 8.4% (95% confidence interval [CI] 1.1 to 15.2%, p=0.025). There was no difference in annual rate of COPD-related contacts to primary or secondary care. There was no difference in time to first moderate-severe exacerbation and time to first severe exacerbation between the FF/VI group vs. the usual care group. There were no excess serious adverse events of pneumonia in the FF/VI group. Other serious adverse events were similar between treatment arms.
Conclusion. In patients with a general practitioner’s diagnosis of COPD and a history of exacerbations, a simple once-daily treatment regimen of combined fluticasone furoate and vilanterol reduced exacerbations without increasing risk of serious adverse events compared to usual care.
The study is registered on clinicaltrials.gov as NCT01551758.
Methods. In a randomized, controlled effectiveness trial, 2,799 patients with a general practitioner’s diagnosis of COPD were initiated on once-daily inhaled combination of 100 μg fluticasone furoate and 25 μg vilanterol (FF/VI) or usual care. The primary outcome was moderate-severe exacerbations in patients who had an exacerbation within 1 year before the study. Secondary outcomes were primary and secondary care contacts, modification to initial study COPD treatment, and time to exacerbations in patients who had an exacerbation within 3 years before the study.
Results. Compared with usual care, the rate of moderate-severe exacerbations was significantly reduced by FF/VI therapy, percent reduction 8.4% (95% confidence interval [CI] 1.1 to 15.2%, p=0.025). There was no difference in annual rate of COPD-related contacts to primary or secondary care. There was no difference in time to first moderate-severe exacerbation and time to first severe exacerbation between the FF/VI group vs. the usual care group. There were no excess serious adverse events of pneumonia in the FF/VI group. Other serious adverse events were similar between treatment arms.
Conclusion. In patients with a general practitioner’s diagnosis of COPD and a history of exacerbations, a simple once-daily treatment regimen of combined fluticasone furoate and vilanterol reduced exacerbations without increasing risk of serious adverse events compared to usual care.
The study is registered on clinicaltrials.gov as NCT01551758.
| Original language | English |
|---|---|
| Pages (from-to) | 1253-1260 |
| Number of pages | 8 |
| Journal | The New England Journal of Medicine |
| Volume | 375 |
| DOIs | |
| Publication status | Published - 29 Sept 2016 |
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Definitive multinational efficacy trials and pioneering ‘real-world’ evidence informing treatments and international strategy for managing chronic obstructive pulmonary disease (COPD)
Vestbo, J. (Participant), Singh, S. (Participant) & (Participant)
Impact: Health and wellbeing