title: Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials.
abstract: BACKGROUND
  Fluticasone furoate (FF)/vilanterol (VI) is a once daily (OD) inhaled corticosteroid/long-acting β2-agonist combination asthma therapy approved in Japan and the EU. FF/VI efficacy and safety data from asthma studies including patients in East Asia were evaluated to assess ethnic sensitivity.
  
  
  METHODS
  Randomized, double-blind, multicenter Phase IIb/III trials were assessed. Change from baseline relative to placebo or twice-daily fluticasone propionate 500 μg in trough FEV1 was compared between patients from Japan (N = 148) and Not-Japan (N = 3,066; three studies). Adverse events (AEs), laboratory results, and electrocardiograms were compared between patients from Japan + Korea (N = 188) and Not-Japan + Korea (N = 3,840; five studies).
  
  
  RESULTS
  For trough FEV1, improvements from baseline (least-squares mean difference [95% confidence interval]) were reported for FF/VI 100/25 μg OD versus placebo at Week 12 (Japan: 0.323 L [0.104-0.542]; Not-Japan: 0.168 L [0.095-0.241]). Improvements from baseline (least-squares mean change [standard error]) were reported with FF/VI 200/25 μg OD at Week 24 (Japan: 0.355 L [0.1152]; Not-Japan: 0.396 L [0.0313]). A greater proportion of patients from Japan + Korea versus Not-Japan + Korea reported AEs in all treatment arms including placebo (FF/VI 100/25 μg: 79% versus 57%; FF/VI 200/25 μg: 64% versus 45%; placebo: 41% versus 23%). There were no notable differences in treatment-related or class-related AEs. No clinically significant changes in electrocardiogram assessments or statistically significant differences in 24 h urinary cortisol excretion were observed between the Japan + Korea and Not-Japan + Korea cohorts.
  
  
  CONCLUSIONS
  Good efficacy and an acceptable safety profile were observed for FF/VI 100/25 μg and 200/25 μg OD in East Asian asthma patients; these globally recommended doses are appropriate for asthma patients in Japan.
  
  
  BACKGROUND
  Clinicaltrials.gov registration numbers: NCT01165138 , NCT01134042 , NCT01086384 , NCT00603278 , NCT00603382 .
authors.affiliation: Clinical Pharmacology Modelling & Simulation, GSK R&D, 82 Hughes Ave, Ermington, Sydney, NSW 2115, Australia. annette.s.gross@gsk.com.
authors.forename: Annette S
authors.initials: AS
authors.lastname: Gross
authors.affiliation: Quantitative Sciences Division, GSK, Uxbridge, UK. caroline.h.goldfrad@gsk.com.
authors.forename: Caroline
authors.initials: C
authors.lastname: Goldfrad
authors.affiliation: Hiroshima Allergy and Respiratory Clinic, Hiroshima, Japan. hozawa@vesta.ocn.ne.jp.
authors.forename: Soichiro
authors.initials: S
authors.lastname: Hozawa
authors.affiliation: Medical Affairs, GSK K.K., Tokyo, Japan. mark.h.james@gsk.com.
authors.forename: Mark H
authors.initials: MH
authors.lastname: James
authors.affiliation: Clinical Pharmacology Modelling & Simulation, GSK R&D, 82 Hughes Ave, Ermington, Sydney, NSW 2115, Australia. christine.x.perry@gsk.com.
authors.forename: Christine S
authors.initials: CS
authors.lastname: Clifton
authors.affiliation: Medicines Development Respiratory, GSK K.K., Tokyo, Japan. yutaro.2.sugiyama@gsk.com.
authors.forename: Yutaro
authors.initials: Y
authors.lastname: Sugiyama
authors.affiliation: Respiratory Medicines Discovery and Development, GSK, Uxbridge, UK. loretta.a.jacques@gsk.com.
authors.forename: Loretta
authors.initials: L
authors.lastname: Jacques
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy / Q000208:ethnology* / Q000503:physiopathology; D001592:Benzyl Alcohols / Q000008:administration & dosage*; D002722:Chlorobenzenes / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005006:Ethnicity; D005202:Asia, Eastern / Q000453:epidemiology; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D009017:Morbidity / Q000639:trends; D018570:Risk Assessment / Q000379:methods*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D001592:Benzyl Alcohols; D002722:Chlorobenzenes; C550468:vilanterol; C523187:fluticasone furoate