title: Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations.
abstract: BACKGROUND
  Umeclidinium (UMEC; long-acting muscarinic antagonist [LAMA])/vilanterol (VI; long-acting beta2-agonist [LABA]) and fluticasone propionate/salmeterol (FP/SAL) (inhaled corticosteroid/LABA) are approved maintenance therapies for chronic obstructive pulmonary disease (COPD). Two studies compared efficacy and safety of UMEC/VI with FP/SAL in patients with moderate-to-severe COPD with no exacerbations in the previous year.
  
  
  METHODS
  In these 12-week, multicenter, double-blind, parallel-group, double-dummy trials, randomized (1:1) patients received once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 250/50 mcg (DB2114930 n = 353 and 353; DB2114951 n = 349 and 348, respectively; intent-to-treat). Endpoints included 0-24 h weighted mean (wm) forced expiratory volume in 1 s (FEV1) (Day 84; primary), trough FEV1 (Day 85; secondary), other lung function endpoints, dyspnea, quality of life (QoL) and safety.
  
  
  RESULTS
  UMEC/VI demonstrated statistically significant, clinically meaningful improvements in lung function measures versus FP/SAL. For 0-24 h wmFEV1 (Day 84), improvements with UMEC/VI versus FP/SAL were 74 mL (95% confidence interval [CI]: 38-110; DB2114930) and 101 mL (63-139; DB2114951) (both p < 0.001). Trough FEV1 improvements were 82 mL (45-119) and 98 mL (59-137) (both p < 0.001) for UMEC/VI versus FP/SAL, respectively. Both treatments demonstrated similar, clinically meaningful improvements from baseline in dyspnea (Transition Dyspnea Index focal score >1 unit) and QoL (St George's Respiratory Questionnaire Total score >4-unit decrease) in both studies with no statistical differences between treatments. Adverse event rates were similar: 26 and 30% UMEC/VI; 27 and 31% FP/SAL.
  
  
  CONCLUSIONS
  Once-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in statistically significant, clinically meaningful improvements in lung function versus twice-daily FP/SAL 250/50 mcg in patients with moderate-to-severe COPD with infrequent exacerbations. Both treatments improved dyspnea and QoL.
  
  
  BACKGROUND
  DB2114930/NCT01817764; DB2114951/NCT01879410.
authors.affiliation: Department of Medicine, University of North Carolina College of Medicine, Chapel Hill, NC 27599, USA. Electronic address: james_donohue@med.unc.edu.
authors.forename: James F
authors.initials: JF
authors.lastname: Donohue
authors.affiliation: The Respiratory Medicines Development Centre, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, UK. Electronic address: sally.d.worsley@gsk.com.
authors.forename: Sally
authors.initials: S
authors.lastname: Worsley
authors.affiliation: The Quantitative Sciences Division, GSK, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, UK. Electronic address: chang-qing.2.zhu@gsk.com.
authors.forename: Chang-Qing
authors.initials: CQ
authors.lastname: Zhu
authors.affiliation: Global Clinical Safety and Pharmacovigilance, GSK, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, UK. Electronic address: liz.x.hardaker@gsk.com.
authors.forename: Liz
authors.initials: L
authors.lastname: Hardaker
authors.affiliation: The Respiratory Medicines Development Center, GSK, 5 Moore Drive, PO Box 13398, Research Triangle Park, NC 27709-3398, USA. Electronic address: alison.x.church@gsk.com.
authors.forename: Alison
authors.initials: A
authors.lastname: Church
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D001592:Benzyl Alcohols / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage; D002722:Chlorobenzenes / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage*; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D012008:Recurrence; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D001592:Benzyl Alcohols; D001993:Bronchodilator Agents; D002722:Chlorobenzenes; D000068297:Fluticasone-Salmeterol Drug Combination; C550468:vilanterol
keywords: COPD; Fluticasone propionate; Salmeterol; Umeclidinium; Vilanterol