title: Fluticasone furoate/vilanterol 200/25 mcg in Asian asthma patients: a randomized trial.
abstract: BACKGROUND
  This study investigated the efficacy and safety of the inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) combination fluticasone furoate (FF)/vilanterol (VI) in Asian asthma patients.
  
  
  METHODS
  A 12-week, double-blind, double-dummy, active-comparator, parallel-group, multicenter study. 309 Asian asthma patients (≥12 years, uncontrolled with high-strength ICS or mid-dose ICS/LABA) were randomized (1:1) and included in the intent-to-treat population; 155 received once-daily FF/VI 200/25 mcg and 154 received twice-daily fluticasone propionate (FP) 500 mcg. The primary endpoint was change from baseline in daily evening peak expiratory flow (PEF) averaged over 12 weeks. Secondary endpoints were mean change from baseline in % rescue-free 24-h periods, daily morning PEF, % symptom-free 24-h periods, and overall Asthma Quality of Life Questionnaire score. Safety assessments were performed.
  
  
  RESULTS
  For change from baseline in daily evening PEF, the adjusted mean treatment difference for FF/VI versus FP of 28.5 L/min (95% confidence interval [CI]: 20.1, 36.9) was clinically and statistically significant (p < 0.001). For change from baseline in % rescue-free 24-h periods, the adjusted mean treatment difference (1.0%; 95% CI: -7.3, 9.2) was not statistically significant (p = 0.821). Statistical significance could not be inferred for the remaining endpoints due to the statistical hierarchy employed. Incidence of on-treatment adverse events was similar with FF/VI (26%; 3% treatment-related; n = 1 serious) and FP (27%; 3% treatment-related; n = 2 serious); none were fatal. No further safety concerns were identified.
  
  
  CONCLUSIONS
  FF/VI improved evening PEF over 12 weeks versus FP in Asian patients, with a similar safety profile. The results are generally consistent with a global study comparing the same treatments.
authors.affiliation: Department of Respiratory Diseases, China-Japan Friendship Hospital, Beijing, 100029, China. Electronic address: jiangtao_l@263.net.
authors.forename: Jiangtao
authors.initials: J
authors.lastname: Lin
authors.affiliation: Department of Respiratory Diseases, The First Affiliated Hospital of China Medical University, Shenyang, 110001, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Kang
authors.affiliation: Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, St. Paul's Hospital, The Catholic University of Korea, Seoul, 130-709, Republic of Korea.
authors.forename: Sang Haak
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Institute of Respiratory Disease, Xinqiao Hospital, Chongqing, 400037, China.
authors.forename: Changzheng
authors.initials: C
authors.lastname: Wang
authors.affiliation: Department of Respiratory Medicine, The First Affiliated Hospital of Third Military Medical University, Chongqing, 400038, China.
authors.forename: Xiangdong
authors.initials: X
authors.lastname: Zhou
authors.affiliation: Quantitative Sciences Division, GSK, Uxbridge, UB11 1BT, UK.
authors.forename: Jodie
authors.initials: J
authors.lastname: Crawford
authors.affiliation: Respiratory Medicines Discovery and Development, GSK, Uxbridge, UB11 1BT, UK.
authors.forename: Loretta
authors.initials: L
authors.lastname: Jacques
authors.affiliation: Respiratory Medicines Discovery and Development, GSK, Uxbridge, UB11 1BT, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Stone
mesh_terms: D000293:Adolescent; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001592:Benzyl Alcohols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002722:Chlorobenzenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D058995:Dry Powder Inhalers; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D000730:Androstadienes; D001592:Benzyl Alcohols; D002722:Chlorobenzenes; D004338:Drug Combinations; D005938:Glucocorticoids; C550468:vilanterol; C523187:fluticasone furoate
keywords: Active-control; Efficacy; Fluticasone propionate; Inhaled corticosteroid; Long-acting beta-agonist; Safety