Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: A 12-week randomized trial

Paul M. O'Byrne, Ashley Woodcock, Eugene R. Bleecker, Eric D. Bateman, Jan Lötvall, Richard Forth, Hilary Medley, Loretta Jacques, William W. Busse

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


Background: Fluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy.Methods: This 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study randomized 248 patients (aged ≥12 years) to once-daily FF 50 mcg administered via the ELLIPTA™ a dry powder inhaler or placebo. The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second (FEV 1 ). Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods (powered), evening and morning peak expiratory flow, symptom-free 24-h periods and withdrawals due to lack of efficacy. Other endpoints included Asthma Control Test™, Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions. Safety was assessed throughout the study.Results: There was a significant difference in evening trough FEV 1 between FF 50 mcg and placebo (treatment difference: 120 mL; p = 0.012). There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo. There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints. The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, <1%; placebo: n = 4, 3%).Conclusion: FF 50 mcg once daily significantly improved FEV 1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo, and was well tolerated.

Original languageEnglish (US)
Article number88
JournalRespiratory Research
Issue number1
StatePublished - Aug 11 2014
Externally publishedYes


  • Fluticasone furoate
  • Inhaled corticosteroid
  • Lung function
  • Once daily
  • Safety

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine


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