title: A phase II study on safety and efficacy of high-dose N-acetylcysteine in patients with cystic fibrosis.
abstract: OBJECTIVE
  We conducted a single-centre, randomised, double-blinded, placebo-controlled phase II clinical study to test safety and efficacy of a 12-week therapy with low-dose (700 mg/daily) or high-dose (2800 mg/daily) of NAC.
  
  
  METHODS
  Twenty-one patients (DeltaF508 homo/heterozygous, FEV1>40% pred.) were included in the study. After a 3-weeks placebo run-in phase, 11 patients received low-dose NAC, and 10 patients received high-dose NAC. Outcomes included safety and clinical parameters, inflammatory (total leukocyte numbers, cell differentials, TNF-alpha, IL-8) measures in induced sputum, and concentrations of extracellular glutathione in induced sputum and blood.
  
  
  RESULTS
  High-dose NAC was a well-tolerated and safe medication. High-dose NAC did not alter clinical or inflammatory parameters. However, extracellular glutathione in induced sputum tended to increase on high-dose NAC.
  
  
  CONCLUSIONS
  High-dose NAC is a well-tolerated and safe medication for a prolonged therapy of patients with CF with a potential to increase extracellular glutathione in CF airways.
authors: University Hospital, Frankfurt/Main, Germany.
authors: N
authors: N
authors: Dauletbaev
authors: P
authors: P
authors: Fischer
authors: B
authors: B
authors: Aulbach
authors: J
authors: J
authors: Gross
authors: W
authors: W
authors: Kusche
authors: U
authors: U
authors: Thyroff-Friesinger
authors: T O F
authors: TO
authors: Wagner
authors: J
authors: J
authors: Bargon
mesh_terms: D000111:Acetylcysteine / Q000008:administration & dosage*; D000328:Adult; D003550:Cystic Fibrosis / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D016166:Free Radical Scavengers / Q000008:administration & dosage*; D005978:Glutathione / Q000378:metabolism; D006801:Humans; D016209:Interleukin-8 / Q000378:metabolism; D008297:Male; D013183:Sputum / Q000378:metabolism; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism; D055815:Young Adult
chemical_list: D016166:Free Radical Scavengers; D016209:Interleukin-8; D014409:Tumor Necrosis Factor-alpha; D005978:Glutathione; D000111:Acetylcysteine