TY - JOUR T1 - Efficacy and safety of once-daily (OD) fluticasone furoate (FF) in patients with persistent asthma: A 24-week randomised trial JF - European Respiratory Journal JO - Eur Respir J VL - 40 IS - Suppl 56 SP - P2123 AU - Jan Lötvall AU - Eugene Bleecker AU - William Busse AU - Paul O'Byrne AU - Ashley Woodcock AU - Eric Bateman AU - Edward Kerwin AU - Sally Stone AU - Richard Forth AU - Loretta Jacques Y1 - 2012/09/01 UR - http://erj.ersjournals.com/content/40/Suppl_56/P2123.abstract N2 - Introduction: The inhaled corticosteroid (ICS) FF is under development as a OD monotherapy for asthma and in combination with the OD long-acting beta2 agonist vilanterol for asthma and COPD.Objectives: To evaluate the efficacy and safety of FF in patients ≥12 years with persistent asthma uncontrolled on a stable low-to-mid dose of ICS (≤500mcg fluticasone propionate [FP] equivalent total daily dose).Methods: In this double-blind, double-dummy, placebo-controlled study, patients (N=343; ITT) received FF (100mcg OD in the evening via a new dry powder inhaler; n=114), FP (250mcg twice daily [BD] via DISKUS™; n=114) or placebo (n=115) for 24 weeks. Primary endpoint: trough FEV1 at 24 weeks. Powered secondary endpoint: change from baseline in % rescue-free 24h periods over 24 weeks. Safety assessments included adverse events (AEs), incidence of severe exacerbations and 24h urinary cortisol (UC) excretion.Results: FF and FP significantly improved trough FEV1 compared with placebo (diff. 146mL [p=0.009] and 145mL [p=0.011], respectively). Significantly more % rescue-free 24h periods were reported for FF (14.8) and FP (17.9) than placebo (both p<0.001). Incidence of on-treatment AEs: FF 53%, FP 42%, placebo 40%. Incidence of on-treatment severe asthma exacerbations: FF 3%, FP 2%, placebo 7%. Statistically significant UC suppression was seen with FF (ratio=0.76; p=0.030) and FP (0.77; p=0.036), relative to placebo.Conclusions: FF 100mcg OD significantly improved trough FEV1 to a similar extent to FP 250mcg BD and reduced rescue use relative to placebo. FF was well tolerated with a similar AE profile and effect on 24h UC to FP.Funded by GSK (FFA112059; NCT01159912). ER -