A phase II study on safety and efficacy of high-dose N-acetylcysteine in patients with cystic fibrosis
| Autor: | N. Dauletbaev, P. Fischer, U. Thyroff-Friesinger, J. Bargon, J. Gross, B. Aulbach, W. Kusche, Tof Wagner |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty lcsh:Medicine Phases of clinical research Gastroenterology Cystic fibrosis law.invention Acetylcysteine Young Adult Double-Blind Method Randomized controlled trial law Forced Expiratory Volume Internal medicine medicine Humans In patient glutathione Dose-Response Relationship Drug Tumor Necrosis Factor-alpha business.industry Research Interleukin-8 lcsh:R Sputum Free Radical Scavengers General Medicine medicine.disease N-acetylcysteine Surgery Clinical trial Dose–response relationship induced sputum inflammation Female medicine.symptom business medicine.drug |
| Zdroj: | European Journal of Medical Research, Vol 14, Iss 8, p 352 (2009) European Journal of Medical Research |
| ISSN: | 2047-783X |
| DOI: | 10.1186/2047-783x-14-8-352 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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