title: Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma.
abstract: The inhaled corticosteroid fluticasone furoate (FF) and the long-acting β₂ 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 aged ≥12 years with moderate-to-severe persistent asthma. Patients (n=586) received FF/VI 200/25 μg or FF 200 μg once-daily (evening dosing), or FP 500 μg 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.
authors.affiliation: Hamilton, ON, Canada.
authors.forename: Paul M
authors.initials: PM
authors.lastname: O'Byrne
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Bleecker
authors.forename: Eric D
authors.initials: ED
authors.lastname: Bateman
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
authors.forename: Ashley
authors.initials: A
authors.lastname: Woodcock
authors.forename: Richard
authors.initials: R
authors.lastname: Forth
authors.forename: William T
authors.initials: WT
authors.lastname: Toler
authors.forename: Loretta
authors.initials: L
authors.lastname: Jacques
authors.forename: Jan
authors.initials: J
authors.lastname: Lötvall
mesh_terms: D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D001592:Benzyl Alcohols / Q000008:administration & dosage*; D002722:Chlorobenzenes / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000379:methods*; D004562:Electrocardiography; D005260:Female; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D001592:Benzyl Alcohols; D002722:Chlorobenzenes; D005938:Glucocorticoids; C550468:vilanterol; C523187:fluticasone furoate; D006854:Hydrocortisone