TY - JOUR T1 - Efficacy and safety of fluticasone furoate (FF)/vilanterol (VI) once daily (OD) for 24 weeks in persistent asthma JF - European Respiratory Journal JO - Eur Respir J VL - 40 IS - Suppl 56 SP - P1794 AU - Paul M. O'Byrne AU - Eugene R. Bleecker AU - Eric D. Bateman AU - William W. Busse AU - Ashley Woodcock AU - Richard Forth AU - Tom Toler AU - Loretta Jacques AU - Jan Lötvall Y1 - 2012/09/01 UR - http://erj.ersjournals.com/content/40/Suppl_56/P1794.abstract N2 - Introduction: FF and VI are, respectively, a novel inhaled corticosteroid and long-acting beta2 agonist in development as a combined OD therapy for asthma and COPD.Objectives: To compare the efficacy and safety of FF/VI with FF and fluticasone propionate (FP) in patients (≥12 years old; on ICS) with moderate-to-severe persistent asthma.Methods: Patients (N=586; intent-to-treat) received FF/VI 200/25mcg OD PM, FF 200mcg OD PM or FP 500mcg twice daily (AM/PM) for 24 weeks. Co-primary endpoints were change from baseline in trough (pre-bronchodilator) FEV1 and weighted mean 0–24h serial FEV1. Secondary endpoints were change from baseline in %rescue-free and %symptom-free 24h periods and Asthma Quality of Life Questionnaire (AQLQ) score. Safety assessments included adverse events (AEs), 24h urinary cortisol (UC) excretion, vital signs and ECG.Results: FF/VI improved trough FEV1 (diff. 193mL and 210mL; both p<0.001) and weighted mean serial FEV1 (diff. 136mL [p=0.048] and 206mL [p=0.003]) vs FF and FP. Significantly more %rescue-free (11.7 [p<0.001]) and %symptom-free (8.4 [p=0.01]) 24h periods were reported with FF/VI vs FF. There was no statistical difference between FF/VI and FF in AQLQ score. Incidence of AEs was similar across groups. No clinically significant difference was seen across treatments with respect to 24-h UC excretion, vital signs or ECG.Conclusions: Treatment with FF/VI over 24 weeks was associated with statistically greater improvements in lung function and asthma stability vs FF and FP, and was well tolerated in this asthma population.Funded by GSK (HZA106829; NCT01134042). ER -