title: Efficacy and safety of fluticasone furoate 100 μg once-daily in patients with persistent asthma: a 24-week placebo and active-controlled randomised trial.
abstract: 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 < 0.001). On-treatment AEs were reported by 53% (FF100 μg OD), 42% (FP250 μg BD) and 40% (placebo) of patients. On-treatment severe asthma exacerbations were lower with FF100 μg OD (3%) and FP250 μg BD (2%) than placebo (7%). There was significant suppression of urinary cortisol at week 24 with FF100 μg OD (p = 0.030) and FP250 μg BD (p = 0.036) relative to placebo. FF100 μg OD, administered in the evening, achieves significant improvements in lung function and rescue inhaler use over 24 weeks, comparable to FP250 μg BD with similar safety profile.
authors.affiliation: Krefting Research Centre, University of Gothenburg, Box 424, SE 40530 Gothenburg, Sweden. Electronic address: jan.lotvall@gu.se.
authors.forename: Jan
authors.initials: J
authors.lastname: Lötvall
authors.affiliation: Center for Genomics and Personalized Medicine, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA.
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Bleecker
authors.affiliation: Department of Medicine, University of Wisconsin, Madison, WI 53706, USA.
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
authors.affiliation: Michael G DeGroote School of Medicine, Hamilton, Ontario L8S4L8, Canada.
authors.forename: Paul M
authors.initials: PM
authors.lastname: O'Byrne
authors.affiliation: Institute of Inflammation and Repair, University of Manchester, University Hospital of South Manchester, Manchester M23 9LT, UK.
authors.forename: Ashley
authors.initials: A
authors.lastname: Woodcock
authors.affiliation: Clinical Research Institute of Southern Oregon, Medford, OR 97504, USA.
authors.forename: Edward M
authors.initials: EM
authors.lastname: Kerwin
authors.affiliation: Respiratory Medicine Development Centre, GlaxoSmithKline, London UB11 1BT, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Stone
authors.affiliation: Quantitative Sciences Division, GlaxoSmithKline, Research Triangle Park, NC 27713, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Forth
authors.affiliation: Respiratory Medicine Development Centre, GlaxoSmithKline, London UB11 1BT, UK.
authors.forename: Loretta
authors.initials: L
authors.lastname: Jacques
authors.affiliation: Department of Medicine, University of Cape Town, Cape Town 7925, South Africa.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Bateman
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009864:Ontario; D013019:South Africa; D013548:Sweden; D016896:Treatment Outcome; D006113:United Kingdom; D014481:United States
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; C523187:fluticasone furoate
keywords: Asthma; Fluticasone furoate; Inhaled corticosteroids; Once-daily