title: One-year safety and efficacy study of arformoterol tartrate in patients with moderate to severe COPD.
abstract: BACKGROUND
  Arformoterol tartrate (arformoterol, 15 μg bid) is a nebulized long-acting β2-agonist approved for maintenance treatment of COPD.
  
  
  METHODS
  This was a multicenter, double-blind, randomized, placebo-controlled study. Patients (aged ≥ 40 years with baseline FEV1 ≤ 65% predicted, FEV1 > 0.50 L, FEV1/FVC ≤ 70%, and ≥ 15 pack-year smoking history) received arformoterol (n = 420) or placebo (n = 421) for 1 year. The primary assessment was time from randomization to respiratory death or first COPD exacerbation-related hospitalization.
  
  
  RESULTS
  Among 841 patients randomized, 103 had ≥ 1 primary event (9.5% vs 15.0%, for arformoterol vs placebo, respectively). Patients who discontinued treatment for any reason (39.3% vs 49.9%, for arformoterol vs placebo, respectively) were followed for up to 1 year postrandomization to assess for primary events. Fewer patients receiving arformoterol than placebo experienced COPD exacerbation-related hospitalizations (9.0% vs 14.3%, respectively). Twelve patients (2.9%) receiving arformoterol and 10 patients (2.4%) receiving placebo died during the study. Risk for first respiratory serious adverse event was 50% lower with arformoterol than placebo (P = .003). Numerically more patients on arformoterol (13; 3.1%) than placebo (10; 2.4%) experienced cardiac serious adverse events; however, time-to-first cardiac serious adverse event was not significantly different. Improvements in trough FEV1 and FVC were greater with arformoterol (least-squares mean change from baseline vs placebo: 0.051 L, P = .030 and 0.075 L, P = .018, respectively). Significant improvements in quality of life (overall St. George's Hospital Respiratory Questionnaire and Clinical COPD Questionnaire) were observed with arformoterol vs placebo (P < .05).
  
  
  CONCLUSIONS
  Arformoterol demonstrated an approximately 40% lower risk of respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo. Arformoterol was well-tolerated and improved lung function vs placebo.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT00909779; URL: www.clinicaltrials.gov.
authors.affiliation: Department of Pulmonary Diseases and Critical Care Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC. Electronic address: jdonohue@med.unc.edu.
authors.forename: James F
authors.initials: JF
authors.lastname: Donohue
authors.affiliation: Section of Pulmonary, Critical Care, and Sleep Medicine, Baylor College of Medicine, Houston, TX.
authors.forename: Nicola A
authors.initials: NA
authors.lastname: Hanania
authors.affiliation: Division of Pulmonary, Critical Care, and Sleep Medicine, National Jewish Health, University of Colorado Denver School of Medicine, Denver, CO.
authors.forename: Barry
authors.initials: B
authors.lastname: Make
authors.affiliation: Department of Pulmonary, Critical Care, Allergy, and Immunologic Medicine, Wake Forest School of Medicine, Winston-Salem, NC.
authors.forename: Matthew C
authors.initials: MC
authors.lastname: Miles
authors.affiliation: Department of Medicine, Geisel School of Medicine at Dartmouth, Hanover, NH.
authors.forename: Donald A
authors.initials: DA
authors.lastname: Mahler
authors.affiliation: Research & Development Division, Sunovion Pharmaceuticals Inc, Marlborough, MA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Curry
authors.affiliation: Research & Development Division, Sunovion Pharmaceuticals Inc, Marlborough, MA.
authors.forename: Robert
authors.initials: R
authors.lastname: Tosiello
authors.affiliation: Research & Development Division, Sunovion Pharmaceuticals Inc, Marlborough, MA.
authors.forename: Alistair
authors.initials: A
authors.lastname: Wheeler
authors.affiliation: Department of Medicine/Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: Donald P
authors.initials: DP
authors.lastname: Tashkin
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology* / Q000503:physiopathology; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety / Q000706:statistics & numerical data; D016016:Proportional Hazards Models; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D012016:Reference Values; D012129:Respiratory Function Tests; D018570:Risk Assessment; D012720:Severity of Illness Index; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D003692:Delayed-Action Preparations; D004983:Ethanolamines; D000068759:Formoterol Fumarate