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Clinical Trial
. 2009 Aug 12;14(8):352-8.
doi: 10.1186/2047-783x-14-8-352.

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

N Dauletbaev  1 , P Fischer, B Aulbach, J Gross, W Kusche, U Thyroff-Friesinger, T O F Wagner, J Bargon
Affiliations
Clinical Trial

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

N Dauletbaev et al. Eur J Med Res. .

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.

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Figures

Figure 1
Figure 1
A. A CONSORT study flow chart of patient enrolment, follow-up and analysis. B. Study design. Visit 3 (at the end of placebo run-in phase) was defined as baseline for subsequent analyses.
Figure 2
Figure 2
Box and whisker plots for FEV1 (% predicted) at each of the five study visits. Whiskers represent minimum and maximum values, box represents 25 and 75 percentiles, • represents median values. Visit 3 at the end of placebo run-in phase defines the baseline.
Figure 3
Figure 3
A. Box and whisker plots for extracellular glutathione in induced sputum at the four study visits when induced sputum samples were collected. Whiskers represent minimum and maximum values, box represents 25 and 75 percentiles, • represents median values. Visit 3 at the end of placebo run-in phase defines the baseline. B. Box and whisker plots for extra-cellular glutathione in blood plasma at the four study visits when blood samples were collected. Whiskers represent minimum and maximum values, box represents 25 and 75 percentiles, • represents median values. Visit 3 at the end of placebo run-in phase defines the baseline.
Figure 4
Figure 4
A. Box and whisker plots for TNF-α in induced sputum at the four study visits when induced sputum samples were collected. Whiskers represent minimum and maximum values, box represents 25 and 75 percentiles, • represents median values. Visit 3 at the end of placebo run-in phase defines the baseline. B. Box and whisker plots for IL-8 in induced sputum at the four study visits when induced sputum samples were collected. Whiskers represent minimum and maximum values, box represents 25 and 75 percentiles, • represents median values. Visit 3 at the end of placebo runin phase defines the baseline.
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