Fluticasone Furate/Vilaterol in Exercising Asthmatic Adolescents: A Randomized and Open Label Trial

Background: Exercise induced asthma (EIA) is common in adolescents. Relvar® (Fluticasone furoate (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was to investigate the short and long-term effects of Relvar® on EIA in adolescents.

Methods: Patients were adolescent asthmatics aged 12-18 years referred for evaluation of EIA. Following a positive exercise challenge test (ECT), Relvar® (92/22 µg) or salbutamol (400 µg) was administered once, in a double blind, double dummy method to assess the short-term effect on EIA. Then they received Relvar® for 30-60 days and were reassessed by a repeat ECT 24-hours after the last dose.

Results: Of 93 adolescents referred for the ECT, 44 had a positive ECT. Of the 44, 22 (22/44) patients were allocated to a single administration of salbutamol and 22 to Relvar. The median FEV1 change was -22.8 (IQR -26.1 and -18.0) and -21.0 (IQR -30.7 and -16.8) % predicted, respectively. Fifteen minutes following bronchodilator use, FEV1 improved similarly in both groups. Repeat ECT following 30-60 days of Relvar® resulted in negative exercise in 33/35 patients; the median decrease in FEV1 of these 35 patients was 22.6% predicted (IQR 29-18) before, and 4.6% predicted (IQR 8.7-2.5) after treatment; p<0.0001).

Conclusions: Relvar® is effective in reversing EIA after 15 minutes in adolescents. Once daily Relvar® is effective in protecting EIA after 30-60 days in adolescents. Protection beyond 24 hours may be due to the longer bronchodilator effect of Vilanterol and/or an anti-inflammatory effect by the inhaled steroids.