A phase II study on safety and efficacy of high-dose N-acetylcysteine in patients with cystic fibrosis

European Journal of Medical Research

J Bargon¹  TOF Wagner²  U Thyroff-Friesinger⁴  W Kusche³  J Gross⁴  B Aulbach²  P Fischer²  N Dauletbaev² 

[1] Hospital St. Elisabeth, Frankfurt/Main, Germany;University Hospital, Frankfurt/Main, Germany;A. CRO Clinical Research Services GmbH, Wiesbaden;Hexal AG, Holzkirchen, Germany

关键词: inflammation;    glutathione;    induced sputum;    N-acetylcysteine;    Cystic fibrosis;   

Others  :  1093620
DOI  :  10.1186/2047-783X-14-8-352

 received in 2009-05-14, accepted in 2009-06-05,  发布年份 2009

【 摘 要 】

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 (ΔF508 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-α, 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.

【 授权许可】

   
2009 I. Holzapfel Publishers

【 图 表 】

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