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.