Once-daily fluticasone furoate 50 mcg in mild-to-moderate asthma: a 24-week placebo-controlled randomized trial.

Abstract

BACKGROUND:

Inhaled glucocorticosteroids (ICS) are the mainstay of treatment in asthma. Fluticasone furoate (FF) is a novel, once-daily ICS asthma therapy. This study investigated the efficacy and safety of FF 50 mcg in patients with mild-to-moderate persistent asthma.

METHODS:

A 24-week, multicenter, randomized, placebo-controlled and active-controlled, double-blind, double-dummy, parallel-group phase III study. Three hundred and fifty-one patients (aged ≥12 years; uncontrolled by non-ICS therapy) were randomized to treatment (1 : 1 : 1) with once-daily FF 50 mcg dosed in the evening, twice-daily fluticasone propionate (FP) 100 mcg or placebo. The primary endpoint was change from baseline in evening trough forced expiratory volume in 1 s (FEV1 ) at Week 24. Secondary endpoints were change from baseline in the percentage of rescue-free 24-h periods (powered endpoint), change from baseline in evening and morning peak expiratory flow, change from baseline in the percentage of symptom-free 24-h periods and number of withdrawals due to lack of efficacy.

RESULTS:

Evening trough FEV1 at Week 24 was not statistically significantly increased with FF 50 mcg once-daily (37 ml [95% CI: -55, 128]; P = 0.430), but was with FP 100 mcg twice daily (102 ml [10, 194]; P = 0.030), vs placebo. No consistent trends were observed across other endpoints, including the powered secondary endpoint. No safety concerns were raised for either active treatment.

CONCLUSIONS:

FP 100 mcg twice daily improved evening trough FEV1 in patients with mild-to-moderate persistent asthma, but FF 50 mcg once daily did not demonstrate a significant effect. Secondary endpoints showed variable results. No safety concerns were identified for FF or FP.

• Authors: W W Busse, E D Bateman, P M O'Byrne, J Lötvall, A Woodcock, H Medley, R Forth, L Jacques
• Journal: Allergy (Allergy) Vol. 69 Issue 11 Pg. 1522-30 (Nov 2014) ISSN: 1398-9995 [Electronic] Denmark
• PMID: 25040613 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 The Authors. Allergy Published by John Wiley & Sons Ltd.

Chemical References

• Androstadienes
• Anti-Asthmatic Agents
• fluticasone furoate

Topics

• Adolescent
• Adult
• Androstadienes (administration & dosage, adverse effects)
• Anti-Asthmatic Agents (administration & dosage, adverse effects)
• Asthma (diagnosis, drug therapy)
• Drug Administration Schedule
• Female
• Forced Expiratory Volume
• Humans
• Male
• Middle Aged
• Severity of Illness Index
• Treatment Outcome
• Young Adult