Abstract
BackgroundFluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy.MethodsThis 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study randomized 248 patients (aged ≥12 years) to once-daily FF 50 mcg administered via the ELLIPTA™a dry powder inhaler or placebo. The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second (FEV1). Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods (powered), evening and morning peak expiratory flow, symptom-free 24-h periods and withdrawals due to lack of efficacy. Other endpoints included Asthma Control Test™, Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions. Safety was assessed throughout the study.ResultsThere was a significant difference in evening trough FEV1 between FF 50 mcg and placebo (treatment difference: 120 mL; p = 0.012). There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo. There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints. The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, <1%; placebo: n = 4, 3%).ConclusionFF 50 mcg once daily significantly improved FEV1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo, and was well tolerated.Trial registrationwww.clinicaltrials.gov, registration number: NCT01436071
Highlights
Fluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients
As part of the overall FF clinical development program, a dose-ranging study (25–200 mcg doses of FF) showed that FF 50 mcg administered over 8 weeks was the minimum dose required to achieve significant improvements in evening trough forced expiratory volume in 1 s (FEV1) and the percentage of rescue-free 24-h periods compared with placebo [7]
Percentage of female patients and screening/baseline characteristics of lung function were similar between treatment groups (Table 1), with a baseline mean% predicted FEV1 of 81.58% in the ITT population
Summary
Fluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy. Inhaled corticosteroids (ICS) are the most effective anti-inflammatory treatments for all severities of persistent asthma [3,4,5]. Patient adherence is a key component to the overall success of asthma treatment, and it has been demonstrated that compliance with a once-daily ICS is better than with a twice-daily regimen [6]. Fluticasone furoate (FF) is a novel once-daily ICS treatment for asthma [7,8,9,10,11], which is used in combination with the long-acting β2-agonist (LABA) vilanterol (VI) for the once-daily treatment of asthma and COPD [12,13,14]. As part of the overall FF clinical development program, a dose-ranging study (25–200 mcg doses of FF) showed that FF 50 mcg administered over 8 weeks was the minimum dose required to achieve significant improvements in evening trough forced expiratory volume in 1 s (FEV1) and the percentage of rescue-free 24-h periods compared with placebo [7]
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