Short- and long-term effects of fluticasone furoate/vilanterol in exercising asthmatic adolescents: A randomized and open label trial

Abstract

Purpose: Relvar® (fluticasone furoate [FF]/vilanterol [VI]) is a once-daily inhaler with bronchodilator effect lasting 24 h. Our aim was to investigate the short- and long-term effects of FF/VI on exercise-induced asthma (EIA) in adolescents. Methods: Ninety-three adolescent asthmatics aged 12–18 years were referred for evaluation of EIA. Following a positive exercise challenge test (ECT), 22/44 were allocated to a single administration of salbutamol (400 μg) and 22/44 to FF/VI (92/22 μg) in a double-blind method. Thirty-five subjects were reassessed by repeat ECT 30–60 days of FF/VI. Results: Median FEV1 change post-ECT at baseline was −22.8% predicted (interquartile range [IQR] −26.1 and −18.0) for salbutamol and −21.0 (IQR −30.7 and −16.8) for FF/VI. Following bronchodilator, FEV1 improved similarly in both groups. Repeat ECT following 30–60 days of FF/VI resulted in negative ECT in 33/35 subjects; the median decrease in FEV1 of these 35 subjects was 22.6% predicted (IQR 29–18) before, and 4.6% predicted (IQR 8.7–2.5) after 30–60 days of FF/VI treatment (p < 0.0001). Conclusions: FF/VI is effective in reversing EIA after 15 min in adolescents and in protecting EIA after 30–60 days in adolescents. Larger studies are needed to assess the effect of FF/VI on EIA.