No dose-response relationship for fluticasone furoate in moderate/severe asthma: 200 mcg once daily worked as well as 800 mcg

Fluticasone furoate (FF) is a new inhaled corticosteroid with 24-hour activity. GlaxoSmithKline is developing FF as a once-daily asthma treatment in combination with the long-acting β2 agonist vilanterol.

This 8-week multicentre, randomized, double-blind study included 600 adult patients with persistent moderate-to-severe asthma, who were symptomatic on medium-dose inhaled corticosteroid therapy. The study was sponsored by GlaxoSmithKline and company employees were among the co-authors.

The patients were randomized to placebo, FF 200, 400, 600 or 800 μg (once daily in the evening using a new dry powder inhaler), or fluticasone propionate 500 μg twice daily (via Diskus or Accuhaler).

Fluticasone furoate, Veramyst (US) and Avamys (EU and Canada), is different in structure from fluticasone propionate (see below). Image source: Wikipedia, public domain.

Fluticasone propionate, Flonase (US and Canada) Flixonase (EU and Brazil). Fluticasone propionate is also part of the ICS/LABA combination product Advair. Image source: Wikipedia, public domain.

Each inhaled steroid dose was superior to placebo for the primary endpoint which was pre-dose evening forced expiratory volume in one second (FEV1). There was no dose–response relationship across the FF doses studied. Peak expiratory flow improved in all groups. The incidence of oral candidiasis was higher with FF 800 μg than placebo; there was also a higher systemic exposure of FF at this highest dose level.

The study authors concluded that FF doses below 800 μg have a favorable therapeutic index, and 200 μg is an appropriate dose in patients with moderate persistent asthma.


Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax 2012;67:35-41 doi:10.1136/thoraxjnl-2011-200308

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