Long-term treatment with oral N-acetylcysteine: Affects lung function but not sputum inflammation in cystic fibrosis subjects. A phase II randomized placebo-controlled trial

C. Conrad, J. Lymp, V. Thompson, C. Dunn, Z. Davies, B. Chatfield, D. Nichols, J. Clancy, R. Vender, M. E. Egan, L. Quittell, P. Michelson, V. Antony, J. Spahr, R. C. Rubenstein, R. B. Moss, L. A. Herzenberg, C. H. Goss, R. Tirouvanziam

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51 Scopus citations

Abstract

Purpose: To evaluate the effects of oral N-acetylcysteine (NAC), which replenishes systemic glutathione, on decreasing inflammation and improving lung function in CF airways. Methods: A multicenter, randomized, double-blind proof of concept study in which 70 CF subjects received NAC or placebo orally thrice daily for 24weeks. Endpoints: primary, change in sputum human neutrophil elastase (HNE) activity; secondary, FEV1 and other clinical lung function measures; and safety, the safety and tolerability of NAC and the potential of NAC to promote pulmonary hypertension in subjects with CF. Results: Lung function (FEV1 and FEF25-75%) remained stable or increased slightly in the NAC group but decreased in the placebo group (p=0.02 and 0.02). Log10 HNE activity remained equal between cohorts (difference 0.21, 95% CI -0.07 to 0.48, p=0.14). Conclusions: NAC recipients maintained their lung function while placebo recipients declined (24week FEV1 treatment effect=150mL, p<0.02). However no effect on HNE activity and other selected biomarkers of neutrophilic inflammation were detected. Further studies on mechanism and clinical outcomes are warranted.

Original languageEnglish (US)
Pages (from-to)219-227
Number of pages9
JournalJournal of Cystic Fibrosis
Volume14
Issue number2
DOIs
StatePublished - Mar 1 2015

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health
  • Pulmonary and Respiratory Medicine

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