PharmaNAC study: cystic fibrosis

A phase 2B clinical study of individuals over the age of 7 is enrolling among people living with cystic fibrosis. The study is looking at the efficacy of PharmaNAC, the effervescent form of NAC that is used by many of us living with chronic infections or conditions. It is enrolling people at various sites in the United States.

NAC is one of the rate-limiting steps in the production of the tripeptide, glutathione. Glutathione is an antioxidant that is critical for the proper functioning of many cells in the body and has particular importance for the liver, lungs, heart, muscles and nervous system. An abstract from the results of a European study of NAC in cystic fibrosis is found below.

    For more information on the study, click on this sentence.

Further information from the Cystic Fibrosis Foundation is found here (although, as they note digestibility may present a problem for some antioxidants, one wonders if agents like glutamine and acidophilus might not also improve outcomes of the use of other agents? This is just a speculation–we need to investigate this further and welcome any input or thoughts.)

Dauletbaev N, Fischer P, Aulbach B, Gross J, Kusche W, Thyroff-Friesinger U, Wagner TO, Bargon J. A phase II study on safety and efficacy of high-dose N-acetylcysteine in patients with cystic fibrosis. Eur J Med Res. 2009 Aug 12;14(8):352-358.
University Hospital, Frankfurt/Main, Germany.

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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See the NYBC entry on PharmaNAC for information on purchasing PharmaNAC from the nonprofit purchasing co-op.

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