Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma

Background: Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD) evening and twice-daily (BD) regimens of the novel inhaled corticosteroid fluticasone furoate (FF) in asthma patients. Methods: Patients with moderate asthma (age >= 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibility of >= 12% and >= 200 ml) were randomized to FF or fluticasone propionate (FP) regimens in a double-blind, crossover study. Patients were not permitted to have used any ICS for >= 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 mu g OD, FF or FP 100 mu g BD and matching placebo by inhalation for 28 days each. Primary endpoint was Day 28 evening pre-dose (trough) FEV1; non-inferiority of FF 200 mu g OD and FF 100 mu g BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs) and 24-hour urinary cortisol excretion were assessed. Results: The intent-to-treat population comprised 147 (FF) and 43 (FP) patients. On Day 28, pre-dose FEV1 showed FF 200 mu g OD to be non-inferior (pre-defined limit -110 ml) to FF 100 mu g BD (mean treatment difference 11 ml; 95% CI: -35 to + 56 ml); all FF and FP regimens were significantly superior to placebo (p <= 0.02). AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 mu g OD, 0.75; 100 mu g BD, 0.84; p = 0.02). Conclusions: FF 200 mu g OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose.