Objective: To evaluate the efficacy and safety of the combination of fluticasone furoate/vilanterol (FF/VI) and compare it with other inhaled combination corticosteroid/long-acting β₂-receptor agonists for maintenance treatment of chronic obstructive pulmonary disease (COPD).

Data sources: A PubMed and EMBASE search in June 2013 using the MeSH terms fluticasone and vilanterol identified trials using this combination for COPD. Additional information was gathered from references cited in the identified publications, the manufacturer, and package insert as well as the ClinicalTrials.gov registry.

Study selection/data extraction: Preference was given to randomized controlled clinical trials. Data from animal trials, clinical trials for asthma, and non-English sources were excluded.

Data synthesis: Given once daily, FF/VI improves trough forced expiratory volume at 1 s by about 230 mL in a 28-day trial versus placebo. However, a more modest increase (100-130 mL) was seen in 2 longer 28-week trials. In the longest trial of 1 year, a slight but significant decrease in the yearly rate of moderate plus severe exacerbations, the time to first moderate or severe exacerbation, and the frequency of exacerbations requiring systemic corticosteroids was seen. There was no difference in the rate of exacerbations requiring hospitalization. The product appears to have the adverse effect profile typical of its class.

Conclusions: Of the inhaled corticosteroid/long-acting β₂ receptor agonist combinations, VI/FF is the first allowing once-daily dosing. Similar to the other combination products, it may slightly decrease the incidence of COPD exacerbations in the patient subset with Global Initiative for Chronic Obstructive Lung Disease risk category C or D. There are no direct safety or efficacy data comparing this with other available inhaled combination products. The once-daily dosing might improve adherence in select patients. The Ellipta delivery device may assist some who are unable to use other devices correctly.