title: Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study.
abstract: BACKGROUND
  Combination long-acting bronchodilator therapy may be more effective than long-acting bronchodilator monotherapy in chronic obstructive pulmonary disease (COPD).
  
  
  OBJECTIVE
  To compare the efficacy and safety of once-daily umeclidinium/vilanterol (UMEC/VI) 125/25 mcg with placebo and UMEC or VI monotherapy in COPD.
  
  
  METHODS
  This was a double-blind, placebo-controlled, parallel-group study. A total of 1493 patients were randomized (3:3:3:2) to 24 weeks of treatment with UMEC/VI 125/25 mcg, UMEC 125 mcg, VI 25 mcg, or placebo once-daily via dry powder inhaler.
  
  
  RESULTS
  Primary efficacy endpoint was trough forced expiratory volume in one second (FEV1) on Day 169 (23-24 h post-dose). Additional lung-function, symptomatic and health-related quality of life endpoints were also assessed. Safety evaluations included: adverse events, vital signs, electrocardiography and clinical laboratory measurements. All active treatments significantly improved trough FEV1 vs placebo (0.124-0.238 L, all p<0.001). Improvements with UMEC/VI 125/25 mcg were significantly greater than for UMEC 125 mcg or VI 25 mcg (0.079 L and 0.114 L; both p≤0.001). Improvements for UMEC/VI 125/25 mcg vs placebo were observed for the transition dyspnea index (1.0 unit; p<0.001), rescue albuterol use at Weeks 1-24 (-1.5 puffs/day) and St. George's Respiratory Questionnaire (-3.60 units, p<0.001). No safety signals were observed.
  
  
  CONCLUSIONS
  Once-daily UMEC/VI 125/25 mcg was well tolerated and provided greater improvements in lung function, health status, and dyspnea scores compared with monotherapy components and placebo over 24 weeks. This study supports the use of UMEC/VI 125/25 mcg for the maintenance treatment of COPD.
  
  
  BACKGROUND
  protocol number: DB2113361; ClinicalTrials.gov identifier: NCT01313637.
authors.affiliation: Brigham and Women's Hospital, Boston, MA. Electronic address: BCelli@copdnet.org.
authors.forename: Bartolome
authors.initials: B
authors.lastname: Celli
authors.affiliation: Medical Division, GlaxoSmithKline, Mississauga, ON, Canada.
authors.forename: Glenn
authors.initials: G
authors.lastname: Crater
authors.affiliation: GlaxoSmithKline, Stockley Park, Uxbridge, England.
authors.forename: Sally
authors.initials: S
authors.lastname: Kilbride
authors.affiliation: Respiratory, GlaxoSmithKline, Research Triangle Park, NC.
authors.forename: Rashmi
authors.initials: R
authors.lastname: Mehta
authors.affiliation: GlaxoSmithKline, Stockley Park, Uxbridge, England.
authors.forename: Maggie
authors.initials: M
authors.lastname: Tabberer
authors.affiliation: Respiratory, GlaxoSmithKline, Research Triangle Park, NC.
authors.forename: Chris J
authors.initials: CJ
authors.lastname: Kalberg
authors.affiliation: Respiratory, GlaxoSmithKline, Research Triangle Park, NC.
authors.forename: Alison
authors.initials: A
authors.lastname: Church
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D001592:Benzyl Alcohols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001993:Bronchodilator Agents / 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; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D011788:Quality of Life; D011812:Quinuclidines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D001592:Benzyl Alcohols; D001993:Bronchodilator Agents; D002722:Chlorobenzenes; D004338:Drug Combinations; C573971:GSK573719; D011812:Quinuclidines; C550468:vilanterol