Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: An 8-week, randomised, placebo-controlled trial

  • Busse W
  • Bleecker E
  • Bateman E
 et al. 
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BACKGROUND: Fluticasone furoate (FF) is a novel inhaled corticosteroid with 24 h activity. FF is being developed as a once-daily treatment in combination with the long-acting beta(2) agonist vilanterol trifenatate for asthma and chronic obstructive pulmonary disease. OBJECTIVES: To determine the optimal dose(s) of FF for treating patients with asthma. METHODS: An 8-week multicentre, randomised, double-blind study. 627 patients with persistent moderate-to-severe asthma, symptomatic on medium-dose inhaled corticosteroid therapy, were randomised to placebo, FF 200, 400, 600 or 800 mug (once daily in the evening using a novel dry powder inhaler), or fluticasone propionate 500 mug twice daily (via Diskus/Accuhaler). The primary efficacy measure was mean change from baseline in pre-dose evening forced expiratory volume in one second (FEV(1)). Other endpoints included morning and evening peak expiratory flow, and rescue/symptom-free 24 h periods. RESULTS: Each dose was significantly superior to placebo for the primary endpoint (p

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  • William W. Busse

  • Eugene R. Bleecker

  • Eric D. Bateman

  • Jan Lötvall

  • Richard Forth

  • Angela M. Davis

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