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

• ABSTRACT: 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 [greater than or equal to]12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibility of [greater than or equal to]12% and [greater than or equal to]200 ml) were randomized to FF or fluticasone propionate (FP) regimens in a double-blind, crossover study. Patients were inhaled corticosteroid-naive and were not permitted to have used any ICS for [greater than or equal to]8 weeks prior to enrolment and subsequently received doses of FF or FP 200 ug OD, FF or FP 100 ug 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 ug OD and FF 100 ug 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 ug OD to be non-inferior (pre-defined limit -110 ml) to FF 100 ug BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml); all FF and FP regimens were significantly superior to placebo (p [less than or equal to] 0.02). Change from placebo in pre-dose FEV1 with OD FP (87 ml) was numerically lower than BD FP (132 ml). AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 ug OD, 0.75; 100 ug BD, 0.84; p [less than or equal to] 0.02). CONCLUSIONS: FF 200 ug OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose. Trial registration: Clinicaltrials.gov; NCT00766090

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Immunology in the medical area (hsv//eng)

Nyckelord

Asthma

fluticasone furoate

inhaled corticosteroid

once daily

efficacy

safety

Publikations- och innehållstyp

ref (ämneskategori)

art (ämneskategori)