Efficacy and safety of fluticasone furoate 100 μg once-daily in patients with persistent asthma: A 24-week placebo and active-controlled randomised trial

Summary Inhaled corticosteroids (ICSs) improve asthma disease control; once-daily ICS administration may have advantages for patients. Our objective was to assess the efficacy and safety of the novel ICS fluticasone furoate (FF) over 24 weeks versus placebo. This was a 24-week double-blind, double-d...

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Bibliographic Details
Published in:Respiratory medicine 2014-01, Vol.108 (1), p.41-49
Main Authors: Lötvall, Jan, Bleecker, Eugene R, Busse, William W, O'Byrne, Paul M, Woodcock, Ashley, Kerwin, Edward M, Stone, Sally, Forth, Richard, Jacques, Loretta, Bateman, Eric D
Format: Article
Language:English
Subjects:
Administration, Inhalation
Adult
Androstadienes - administration & dosage
Androstadienes - adverse effects
Androstadienes - therapeutic use
Asthma
Asthma - drug therapy
Bronchodilator Agents - administration & dosage
Bronchodilator Agents - adverse effects
Bronchodilator Agents - therapeutic use
Double-Blind Method
Drug Administration Schedule
Female
Fluticasone furoate
Humans
Inhaled corticosteroids
Lungmedicin och allergi
Male
Middle Aged
Once-daily
Ontario
Pulmonary/Respiratory
Respiratory Medicine and Allergy
South Africa
Sweden
Treatment Outcome
United Kingdom
United States
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Summary:Summary Inhaled corticosteroids (ICSs) improve asthma disease control; once-daily ICS administration may have advantages for patients. Our objective was to assess the efficacy and safety of the novel ICS fluticasone furoate (FF) over 24 weeks versus placebo. This was a 24-week double-blind, double-dummy, placebo- and active-controlled study ( NCT01159912 ) of 343 asthma patients (≥12 years) not controlled by their current ICS. Patients were randomised (1:1:1) to FF100 μg, placebo (both administered once-daily [OD] via ELLIPTA™ dry powder inhaler in the evening) or fluticasone propionate (FP) 250 μg (administered twice-daily (BD) via DISKUS™/ACCUHALER™). Primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1s (FEV1 ) at Week 24; change from baseline in % rescue-free 24-h periods was a powered secondary endpoint. Adverse events (AEs) were assessed. FF100 μg OD and FP250 μg BD significantly improved pre-dose evening FEV1 compared with placebo at Week 24 (+146 ml [ p  = 0.009] and +145 ml [ p  = 0.011], respectively). Percentage of rescue-free 24-h periods was increased with FF100 μg OD (+14.8%) and FP250 μg BD (+17.9%) compared to placebo (both p  
ISSN:0954-6111
1532-3064
DOI:10.1016/j.rmed.2013.11.009