Data from: Efficacy and safety of four weeks’ treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial

BACKGROUND: 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.
TRIAL DESIGN: A multicentre, randomised, double-blind, parallel-group,
placebo-controlled study. METHODS: 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. RESULTS: 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). CONCLUSION: FF/VI has a good
safety and tolerability profile and improves lung function compared with
placebo in patients with COPD.