title: The efficacy and safety of the novel long-acting β2 agonist vilanterol in patients with COPD: a randomized placebo-controlled trial.
abstract: BACKGROUND
  Vilanterol (GW642444M) (VI) is a novel, inhaled, long-acting β(2) agonist with inherent 24-h activity under development as a once-daily combination therapy with an inhaled corticosteroid for COPD and asthma. This study assessed the dose response, efficacy, and safety of VI at doses of 3 to 50 μg in patients with moderate to severe COPD.
  
  
  METHODS
  Six hundred two patients (intent-to-treat) were randomized (double-blind) to VI 3, 6.25, 12.5, 25, or 50 μg or placebo once daily for 28 days. The primary end point was change from baseline in trough FEV1 at the end of the 28-day treatment period. Secondary end points included 0- to 24-h weighted mean FEV(1) on days 1 and 28 and time to increases of ≥ 100 mL or ≥ 12% from baseline FEV(1) on day 1. Safety assessments included adverse events, vital signs, ECG assessment, and clinical laboratory tests.
  
  
  RESULTS
  VI once daily for 28 days significantly improved trough FEV(1) in a dose-dependent manner vs placebo. Clinically relevant treatment differences of ≥ 130 mL in trough and 0- to 24-h weighted mean FEV(1) were observed with VI 25- and 50-μg doses vs placebo. All doses of VI were associated with a low incidence of treatment-related adverse events/serious adverse events, with no suggestion of effects on BP, pulse rate, QT intervals corrected for heart rate calculated by Fridericia formula, or blood glucose and potassium levels.
  
  
  CONCLUSIONS
  VI 25 and 50 μg once daily provided both statistically and clinically relevant 24-h improvements in lung function in patients with COPD compared with placebo. All doses of VI had a safety and tolerability profile similar to placebo.
authors.affiliation: Section of Pulmonary and Critical Care, Baylor College of Medicine, Houston, TX. Electronic address: hanania@bcm.tmc.edu.
authors.forename: Nicola A
authors.initials: NA
authors.lastname: Hanania
authors.affiliation: S. Carolina Pharmaceutical Research, Spartanburg, SC.
authors.forename: Gregory
authors.initials: G
authors.lastname: Feldman
authors.affiliation: Pneumologisches Forschungsinstitut Hohegeest, Geesthacht, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Zachgo
authors.affiliation: Department of Pulmonology, Allergy, and Critical Care Medicine, Guro Hospital, Seoul, South Korea.
authors.forename: Jae-Jeong
authors.initials: JJ
authors.lastname: Shim
authors.affiliation: Respiratory and Medicines Development Center, GlaxoSmithKline, Research Triangle Park, NC.
authors.forename: Courtney
authors.initials: C
authors.lastname: Crim
authors.affiliation: Respiratory and Medicines Development Centre, GlaxoSmithKline, Uxbridge, England.
authors.forename: Lisa
authors.initials: L
authors.lastname: Sanford
authors.affiliation: Respiratory and Medicines Development Centre, GlaxoSmithKline, Uxbridge, England.
authors.forename: Sally
authors.initials: S
authors.lastname: Lettis
authors.affiliation: Respiratory and Medicines Development Center, GlaxoSmithKline, Research Triangle Park, NC.
authors.forename: Frank
authors.initials: F
authors.lastname: Barnhart
authors.affiliation: Respiratory and Medicines Development Centre, GlaxoSmithKline, Uxbridge, England.
authors.forename: Brett
authors.initials: B
authors.lastname: Haumann
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D058666:Adrenergic beta-2 Receptor Agonists / Q000009:adverse effects* / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001592:Benzyl Alcohols / Q000009:adverse effects* / Q000627:therapeutic use*; D002722:Chlorobenzenes / Q000009:adverse effects* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D058666:Adrenergic beta-2 Receptor Agonists; D001592:Benzyl Alcohols; D002722:Chlorobenzenes; C550468:vilanterol