@article {O{\textquoteright}Byrneerj00645-2013, author = {Paul M O{\textquoteright}Byrne and Eugene R. Bleecker and Eric D. Bateman and William W. Busse and Ashley Woodcock and Richard Forth and William T. Toler and Loretta Jacques and Jan L{\"o}tvall}, title = {Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma}, elocation-id = {erj00645-2013}, year = {2013}, doi = {10.1183/09031936.00064513}, publisher = {European Respiratory Society}, abstract = {The inhaled corticosteroid fluticasone furoate (FF) and the long-acting β2 agonist vilanterol (VI) are in development as a combined once-daily therapy for asthma and COPD. Study objectives were to compare the efficacy and safety of once-daily FF/VI with FF alone and twice-daily fluticasone propionate (FP) in patients >=12 years of age with moderate-to-severe persistent asthma.Patients (N=586) received FF/VI 200/25 μg or FF 200 μg once-daily (evening dosing), or FP 500 μg twice-daily for 24 weeks. Co-primary endpoints: change from baseline in trough FEV1; weighted mean (wm) 0{\textendash}24 h serial FEV1. Secondary endpoints included change from baseline in percentage rescue-free 24-h periods, percentage symptom-free 24-h periods and Total Asthma Quality of Life Questionnaire (AQLQ). Safety assessments included adverse events (AEs), 24 h urinary cortisol (UC) excretion, vital signs and ECG.FF/VI significantly improved trough FEV1 and wm FEV1 versus FF and FP. Significantly more rescue-free and symptom-free 24-h periods were reported with FF/VI versus FF. Treatment differences for AQLQ were not significant. Incidence of AEs was similar across groups. No clinically significant differences were seen for 24 h UC excretion, vital signs or ECG.FF/VI resulted in statistically greater improvements in lung function and symptomatic endpoints versus FF, and was well tolerated in this asthma population.}, issn = {0903-1936}, URL = {https://erj.ersjournals.com/content/early/2013/10/16/09031936.00064513}, eprint = {https://erj.ersjournals.com/content/early/2013/10/16/09031936.00064513.full.pdf}, journal = {European Respiratory Journal} }