Publication Details

AFRICAN RESEARCH NEXUS

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medicine

Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma

European Respiratory Journal, Volume 43, No. 3, Year 2014

The inhaled corticosteroid fluticasone furoate (FF) and the long-acting b2 agonist vilanterol (VI) are in development as a combined once-daily therapy for asthma and chronic obstructive pulmonary disease. Our study objectives were to compare the efficacy and safety of once-daily FF/VI with FF alone and twice-daily fluticasone propionate (FP) in patients agedo12 years withmoderate-to-severe persistent asthma. Patients (n5586) received FF/VI 200/25 mg or FF 200 mg once-daily (evening dosing), or FP 500 mg twice-daily for 24 weeks. Co-primary end-points were change from baseline in trough forced expiratory volume in 1 s (FEV1) weighted mean (wm) 0-24 h serial FEV1. Secondary end-points included change from baseline in percentage of rescue-free 24-h periods, percentage of symptom-free 24-h periods and total Asthma Quality of Life Questionnaire (AQLQ). Safety assessments included adverse events, 24-h urinary cortisol excretion, vital signs and ECG. FF/VI significantly improved trough FEV1 and wmFEV1 versus FF and FP. Significantly more rescue-free and symptom-free 24-h periods were reported with FF/VI versus FF. Treatment differences for AQLQ were not significant. Incidence of adverse events was similar across groups. No clinically significant differences were seen for 24-h urinary cortisol excretion, vital signs or ECG. FF/VI resulted in statistically greater improvements in lung function and symptomatic end-points versus FF, and was well tolerated in this asthma population.
Statistics
Citations: 82
Authors: 9
Affiliations: 8
Identifiers
Research Areas
Disability
Study Design
Cross Sectional Study
Cohort Study