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

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

    Research output: Contribution to journalArticlepeer-review

    Abstract

    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 β(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 μg (once daily in the evening using a novel dry powder inhaler), or fluticasone propionate 500 μg 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
    Original languageEnglish
    Pages (from-to)35-41
    Number of pages6
    JournalThorax
    Volume67
    Issue number1
    DOIs
    Publication statusPublished - Jan 2012

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