Dose effect of once-daily fluticasone furoate in persistent asthma: A randomized trial

Eric D. Bateman, Eugene R. Bleecker, Jan Lötvall, Ashley Woodcock, Richard Forth, Hilary Medley, Angela M. Davis, Loretta Jacques, Brett Haumann, William W. Busse

Research output: Contribution to journalArticlepeer-review

62 Scopus citations

Abstract

Background: This randomized, double-blind, multicenter study was designed to evaluate the efficacy of inhaled once-daily fluticasone furoate (FF) administered in the evening in patients with persistent asthma not controlled by short-acting beta 2 agonists, and to determine the dose(s) suitable for further development. Methods: Of 1459 patients screened, 598 received one of six treatments: placebo, FF (25 μg, 50 μg, 100 μg or 200 μg) once daily each evening, or fluticasone propionate (FP) 100 μg twice daily for 8 weeks. The primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1 s (FEV 1). Results: A dose-response effect was observed for once-daily FF 25-200 μg including (p < 0.001) and excluding placebo (p = 0.03). FF 50-200 μg once daily significantly increased FEV 1 from baseline (p < 0.05 vs placebo), by >200 mL for FF 100 μg and 200 μg. Significant improvements were also achieved for peak expiratory flow, and percentage symptom-free and rescue-free 24 h periods. The magnitude of effect was at least as good as twice-daily FP. Overall, once-daily FF was well tolerated with no systemic corticosteroid effects. Conclusion: FF 50-200 μg/day once daily in the evening demonstrated dose-related efficacy in asthma with 100-200 μg appearing to be the optimal doses for further evaluation.

Original languageEnglish (US)
Pages (from-to)642-650
Number of pages9
JournalRespiratory Medicine
Volume106
Issue number5
DOIs
StatePublished - May 2012
Externally publishedYes

Keywords

  • Asthma
  • Dose-response
  • Evening dosing
  • Fluticasone furoate
  • Inhaled corticosteroids
  • Once-daily dosing

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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