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

Woodcock, Ashley; Bateman, Eric D; Busse, William W; Lotvall, Jan; Snowise, Neil G; Forth, Richard; Jacques, Loretta; Haumann, Brett; Bleecker, Eugene R

Respiratory research. 2011;12(1):132.

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Abstract

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 [greater than or equal to]3 months with baseline morning forced expiratory volume in one second (FEV1) 50-80% of predicted normal value and FEV1 reversibility of [greater than or equal to]12% and [greater than or equal to]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 (240ml vs. 235ml). 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 (315ml vs. 202ml). 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 200mcg or 400mcg 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.

Bibliographic metadata

Type of resource:
Content type:
Publication type:
Published date:
Journal title:
Abbreviated journal title:
ISSN:
Volume:
12
Issue:
1
Pagination:
132
Digital Object Identifier:
10.1186/1465-9921-12-132
Pubmed Identifier:
21977941
Pii Identifier:
1465-9921-12-132
Access state:
Active

Institutional metadata

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Record metadata

Manchester eScholar ID:
uk-ac-man-scw:134336
Created by:
Taylor, Scott
Created:
26th October, 2011, 12:24:11
Last modified by:
Taylor, Scott
Last modified:
7th July, 2014, 18:15:06

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