Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial.

Abstract

BACKGROUND:

This randomized, double-blind, multicenter study was designed to evaluate the efficacy of inhaled once-daily fluticasone furoate (FF) administered in the evening in patients with persistent asthma not controlled by short-acting beta(2) agonists, and to determine the dose(s) suitable for further development.

METHODS:

Of 1459 patients screened, 598 received one of six treatments: placebo, FF (25 μg, 50 μg, 100 μg or 200 μg) once daily each evening, or fluticasone propionate (FP) 100 μg twice daily for 8 weeks. The primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1 s (FEV(1)).

RESULTS:

A dose-response effect was observed for once-daily FF 25-200 μg including (p < 0.001) and excluding placebo (p = 0.03). FF 50-200 μg once daily significantly increased FEV(1) from baseline (p < 0.05 vs placebo), by >200 mL for FF 100 μg and 200 μg. Significant improvements were also achieved for peak expiratory flow, and percentage symptom-free and rescue-free 24 h periods. The magnitude of effect was at least as good as twice-daily FP. Overall, once-daily FF was well tolerated with no systemic corticosteroid effects.

CONCLUSION:

FF 50-200 μg/day once daily in the evening demonstrated dose-related efficacy in asthma with 100-200 μg appearing to be the optimal doses for further evaluation. ClinicalTrials.gov: NCT00603382.

• Authors: Eric D Bateman, Eugene R Bleecker, Jan Lötvall, Ashley Woodcock, Richard Forth, Hilary Medley, Angela M Davis, Loretta Jacques, Brett Haumann, William W Busse
• Journal: Respiratory medicine (Respir Med) Vol. 106 Issue 5 Pg. 642-50 (May 2012) ISSN: 1532-3064 [Electronic] England
• PMID: 22342538 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier Ltd. All rights reserved.

Chemical References

• Androstadienes
• Anti-Asthmatic Agents
• Glucocorticoids
• Fluticasone
• fluticasone furoate

Topics

• Adolescent
• Adult
• Aged
• Androstadienes (administration & dosage, adverse effects, blood, therapeutic use)
• Anti-Asthmatic Agents (administration & dosage, adverse effects, blood, therapeutic use)
• Asthma (blood, drug therapy, physiopathology)
• Child
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Fluticasone
• Forced Expiratory Volume (drug effects)
• Glucocorticoids (administration & dosage, adverse effects, blood, therapeutic use)
• Humans
• Male
• Middle Aged
• Treatment Outcome
• Young Adult