Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma

Paul M. O'Byrne, Eugene R. Bleecker, Eric D. Bateman, William W. Busse, Ashley Woodcock, Richard Forth, William T. Toler, Loretta Jacques, Jan Lötvall

Research output: Contribution to journalArticlepeer-review

76 Scopus citations


The inhaled corticosteroid fluticasone furoate (FF) and the long-acting b2 agonist vilanterol (VI) are in development as a combined once-daily therapy for asthma and chronic obstructive pulmonary disease. Our 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 agedo12 years withmoderate-to-severe persistent asthma. Patients (n5586) received FF/VI 200/25 mg or FF 200 mg once-daily (evening dosing), or FP 500 mg twice-daily for 24 weeks. Co-primary end-points were change from baseline in trough forced expiratory volume in 1 s (FEV1) weighted mean (wm) 0-24 h serial FEV1. Secondary end-points included change from baseline in percentage of rescue-free 24-h periods, percentage of symptom-free 24-h periods and total Asthma Quality of Life Questionnaire (AQLQ). Safety assessments included adverse events, 24-h urinary cortisol excretion, vital signs and ECG. FF/VI significantly improved trough FEV1 and wmFEV1 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 adverse events was similar across groups. No clinically significant differences were seen for 24-h urinary cortisol excretion, vital signs or ECG. FF/VI resulted in statistically greater improvements in lung function and symptomatic end-points versus FF, and was well tolerated in this asthma population.

Original languageEnglish (US)
Pages (from-to)773-782
Number of pages10
JournalEuropean Respiratory Journal
Issue number3
StatePublished - Mar 1 2014
Externally publishedYes

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine


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