A phase II study on safety and efficacy of high-dose N-acetylcysteine in patients with cystic fibrosis.
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.
Dauletbaev
N
N
University Hospital, Frankfurt/Main, Germany.
Fischer
P
P
Aulbach
B
B
Gross
J
J
Kusche
W
W
Thyroff-Friesinger
U
U
Wagner
T O F
TO
Bargon
J
J
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
D016166:Free Radical Scavengers; D016209:Interleukin-8; D014409:Tumor Necrosis Factor-alpha; D005978:Glutathione; D000111:Acetylcysteine