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Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial

Ashley Woodcock1*, Eric D Bateman2, William W Busse3, Jan Lötvall4, Neil G Snowise5, Richard Forth6, Loretta Jacques5, Brett Haumann5 and Eugene R Bleecker7

Author Affiliations

1 School of Translational Medicine, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK

2 Department of Medicine, University of Cape Town, Cape Town, South Africa

3 Department of Medicine, University of Wisconsin, Madison, USA

4 Krefting Research Centre, University of Gothenberg, Gothenberg, Sweden

5 Respiratory Medicines Development Centre, GlaxoSmithKline, Uxbridge, UK

6 Respiratory Medicines Development Center, Research Triangle Park, NC, USA

7 Center for Genomics and Personalized Medicine, Wake Forest University Health Sciences Winston-Salem, NC, USA

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Respiratory Research 2011, 12:132  doi:10.1186/1465-9921-12-132

Published: 6 October 2011

Abstract

Background

Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). This double-blind, placebo-controlled randomized study evaluated the efficacy and safety of FF 200 mcg or 400 mcg once daily, either in the morning or in the evening, and FF 200 mcg twice daily (morning and evening), for 8 weeks in patients with persistent asthma.

Methods

Asthma patients maintained on ICS for ≥ 3 months with baseline morning forced expiratory volume in one second (FEV1) 50-80% of predicted normal value and FEV1 reversibility of ≥ 12% and ≥ 200 ml were eligible. The primary endpoint was mean change from baseline FEV1 at week 8 in pre-dose (morning or evening [depending on regimen], pre-rescue bronchodilator) FEV1.

Results

A total of 545 patients received one of five FF treatment groups and 101 patients received placebo (intent-to-treat population). Each of the five FF treatment groups produced a statistically significant improvement in pre-dose FEV1 compared with placebo (p < 0.05). FF 400 mcg once daily in the evening and FF 200 mcg twice daily produced similar placebo-adjusted improvements in evening pre-dose FEV1 at week 8 (240 ml vs. 235 ml). FF 400 mcg once daily in the morning, although effective, resulted in a smaller improvement in morning pre-dose FEV1 than FF 200 mcg twice daily at week 8 (315 ml vs. 202 ml). The incidence of oral candidiasis was low (0-4%) and UC excretion was comparable with placebo for all FF groups.

Conclusions

FF at total daily doses of 200 mcg or 400 mcg was significantly more effective than placebo. FF 400 mcg once daily in the evening had similar efficacy to FF 200 mcg twice daily and all FF regimens had a safety tolerability profile generally similar to placebo. This indicates that inhaled FF is an effective and well tolerated once-daily treatment for mild-to-moderate asthma.

Trial registration

NCT00398645

Keywords:
once-daily; ICS; asthma