Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/long-acting β2 agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma.
A multicentre, randomised, double-blind, parallel-group, placebo-controlled study.
Participants were patients with moderate-to-severe COPD treated with placebo or FF/VI 400/25 μg OD for 4 weeks. Study objectives were to assess the safety and efficacy of FF/VI 400/25 μg OD administered for 4 weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0–4 h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points included change from baseline in trough forced expiratory volume in one second (FEV1) (23–24 h postdose; day 29) and wm FEV1 (0–4 h postdose; day 28). Patients were randomised to receive FF/VI 400/25 μg or placebo in a 2:1 ratio; all patients and investigators were blinded to active or placebo treatment.
60 patients (mean age 64 years) were randomised (FF/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean screening post-bronchodilator FEV1 per cent predicted was comparable between groups (FF/VI: 58.5%; placebo: 60.1%). The wm heart rate 0–4 h postdose was similar between groups (difference: 0.6 beats per minute; 95% CI −3.9 to 5.1). More on-treatment AEs were reported in the FF/VI group (68%) compared with the placebo group (50%). The most common drug-related AEs in the FF/VI group were oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant effects on laboratory values, including glucose and potassium, or on vital signs or ECGs/Holters. The FF/VI group had statistically greater improvements compared with placebo in trough FEV1 (mean difference 183 ml) and 0–4 h postdose wm FEV1 (mean difference 236 ml).
FF/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD.
Trial registration number
Is the once-daily inhaled corticosteroid/long-acting β2 agonist (ICS/LABA) combination FF/VI efficacious with a favourable safety and tolerability profile in COPD?
In patients with moderate-to-severe COPD, FF/VI 400/25 μg once daily improved lung function. AEs frequently experienced with other ICS/LABA combinations were generally reported at similar frequencies in the placebo and active treatment arms.
Strengths and limitations of this study
This paper is the first to present clinical data on inhaled FF/VI combination therapy in patients with chronic obstructive lung disease. Given the 4-week duration of this study, there was no end point or surrogate marker to specifically address the relative clinical effects of FF in COPD (such as exacerbations), whereas the observed lung function effects are predominantly induced by the LABA component of the combination.