Source: Annual Congress 2010 - New treatments for asthma and COPD
Disease area: Airway diseases

Abstract

Introduction: FF is a novel ICS still active at 24 hours and under development as an OD treatment.
Objectives: To evaluate the efficacy and safety of OD and twice-daily (BD) dosing and of morning and evening dosing of FF in asthma patients ≥12 years.
Methods: Multicentre, randomised, double-blind, parallel group, placebo-controlled study to evaluate FF 200mcg BD, FF 200mcg and 400mcg OD in the morning, and FF 200mcg and 400mcg OD in the evening compared with placebo. 652 patients were randomised to 8 weeks of treatment, with a mean age of 45 years, 65% female, baseline mean pre-bronchodilator FEV₁ mean 67% predicted and 29% mean FEV₁ reversibility. The primary endpoint was the mean change from baseline at Week 8 in trough (AM or PM) FEV₁.
Results: FF 400mcg OD in the evening and FF 200mcg BD resulted in comparable, placebo-adjusted improvements in PM trough FEV₁ after 8 weeks of dosing (240mL and 235mL, respectively). FF 200mcg BD resulted in greater improvements in placebo-adjusted AM trough FEV₁ than FF 400mcg OD in the morning after 8 weeks of dosing (315mL and 202mL, respectively). FF was well tolerated in this study with a low incidence of adverse events, comparable across treatment groups. Urinary cortisol was comparable with placebo for all groups.
Conclusion: Efficacy of FF 400mcg OD in the evening was comparable with 200mcg BD supporting FF as a well-tolerated and efficacious once-daily ICS.
Funded by GSK (FFA106783; NCT00398645)

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A. Woodcock, E. R. Bleecker, E. D. Bateman, W. Busse, J. Lötvall, N. Snowise, R. Forth, L. Jacques, B. Haumann (Manchester, London, United Kingdom; Winston-Salem, Madison, RTP, United States Of America; Cape Town, South Africa; Gothenberg, Sweden). Fluticasone furoate (FF), a novel inhaled corticosteroid (ICS), demonstrates once-daily (OD) efficacy in asthma when dosed in the evening. Eur Respir J 2010; 36: Suppl. 54, 1170

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