title: TNFα antagonists for acute exacerbations of COPD: a randomised double-blind controlled trial.
abstract: BACKGROUND
  The purpose of this randomised double-blind double-dummy placebo-controlled trial was to investigate whether etanercept, a tumour necrosis factor α (TNFα) antagonist, would provide more effective anti-inflammatory treatment for acute exacerbations of chronic obstructive pulmonary disease (COPD) than prednisone.
  
  
  METHODS
  We enrolled 81 patients with acute exacerbations of COPD and randomly assigned them to treatment with either 40 mg oral prednisone given daily for 10 days or to 50 mg etanercept given subcutaneously at randomisation and 1 week later. Both groups received levofloxacin for 10 days plus inhaled bronchodilators. The primary endpoint was the change in the patient's forced expiratory volume in 1 s (FEV(1)) 14 days after randomisation. Secondary endpoints included 90-day treatment failure rates and dyspnoea and quality of life.
  
  
  RESULTS
  At 14 days the mean±SE change in FEV(1) from baseline was 20.1±5.0% and 15.2±5.7% for the prednisone and etanercept groups, respectively. The mean between-treatment difference was 4.9% (95% CI -10.3% to 20.2%), p=0.52. Rates of treatment failure at 90 days were similar in the prednisone and etanercept groups (32% vs 40%, p=0.44), as were measures of dyspnoea and quality of life. Subgroup analysis revealed that patients with serum eosinophils >2% at exacerbation tended to experience fewer treatment failures if treated with prednisone compared with etanercept (22% vs 50%, p=0.08).
  
  
  CONCLUSIONS
  Etanercept was not more effective than prednisone for treatment of acute exacerbations of COPD. Efficacy of prednisone was most apparent in patients who presented with serum eosinophils >2%.
  
  
  RESULTS
  gov number NCT 00789997.
authors.affiliation: Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada. saaron@ohri.ca
authors.forename: Shawn D
authors.initials: SD
authors.lastname: Aaron
authors.forename: Katherine L
authors.initials: KL
authors.lastname: Vandemheen
authors.forename: François
authors.initials: F
authors.lastname: Maltais
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Field
authors.forename: Don D
authors.initials: DD
authors.lastname: Sin
authors.forename: Jean
authors.initials: J
authors.lastname: Bourbeau
authors.forename: Darcy D
authors.initials: DD
authors.lastname: Marciniuk
authors.forename: J Mark
authors.initials: JM
authors.lastname: FitzGerald
authors.forename: Parameswaran
authors.initials: P
authors.lastname: Nair
authors.forename: Ranjeeta
authors.initials: R
authors.lastname: Mallick
mesh_terms: D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D000068800:Etanercept; D005260:Female; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use; D011241:Prednisone / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005938:Glucocorticoids; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D064704:Levofloxacin; D015242:Ofloxacin; D000068800:Etanercept; D011241:Prednisone