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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.
Conrad, C; Lymp, J; Thompson, V; Dunn, C; Davies, Z; Chatfield, B; Nichols, D; Clancy, J; Vender, R; Egan, M E; Quittell, L; Michelson, P; Antony, V; Spahr, J; Rubenstein, R C; Moss, R B; Herzenberg, L A; Goss, C H; Tirouvanziam, R.
Afiliación
  • Conrad C; Lucile Packard Children's Hospital, Center of Excellence in Pulmonary Biology, 770 Welch Rd., #350, Stanford University, Palo Alto, CA 94304, United States.
  • Lymp J; CFFT Therapeutics Development Network Coordinating Center, Seattle, WA. 2001 8th Avenue, Seattle, WA 98121, United States.
  • Thompson V; CFFT Therapeutics Development Network Coordinating Center, Seattle, WA. 2001 8th Avenue, Seattle, WA 98121, United States.
  • Dunn C; Lucile Packard Children's Hospital, Center of Excellence in Pulmonary Biology, 770 Welch Rd., #350, Stanford University, Palo Alto, CA 94304, United States.
  • Davies Z; Lucile Packard Children's Hospital, Center of Excellence in Pulmonary Biology, 770 Welch Rd., #350, Stanford University, Palo Alto, CA 94304, United States.
  • Chatfield B; University of Utah Pediatric Pulmonology, 100N. Mario Capecchi Dr., Salt Lake City, UT 84113, United States.
  • Nichols D; National Jewish Health, 1400 Jackson St., Adult CF Center, Denver, CO 80206, United States.
  • Clancy J; Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Pulmonary Medicine, OSB 5, Cincinnati, OH 45229, United States.
  • Vender R; Pennsylvania State University/Milton S. Hershey Medical Center, PO Box 850, Hershey, PA 17033, United States.
  • Egan ME; Yale University School of Medicine, Yale University School of Medicine, 333 Cedar St., Rm. FMP 526, New Haven, CT 06520, United States.
  • Quittell L; Morgan Stanley Children's Hospital of New York, Division of Pediatric Pulmonology, Columbia University Medical Center, 3959 Broadway CHC 7-701, New York, NY 10032, United States.
  • Michelson P; St. Louis Children's Hospital, 660 Euclid Ave., CF Center, 10th Floor NW Tower, St. Louis, MO 63110, United States.
  • Antony V; University of Alabama at Birmingham, 422 Tinsley Harrison Tower, 1900 University Blvd, Birmingham, AL 35294-0006, United States.
  • Spahr J; Children's Hospital of Pittsburgh of UPMC, 4221 Penn Avenue, AOB Suite 3300, Pittsburgh, PA 15224, United States.
  • Rubenstein RC; The Children's Hospital of Philadelphia, 34th St and Civic Center Blvd, Abramson Research Center, Room 410A, Philadelphia, PA 19104, United States.
  • Moss RB; Lucile Packard Children's Hospital, Center of Excellence in Pulmonary Biology, 770 Welch Rd., #350, Stanford University, Palo Alto, CA 94304, United States.
  • Herzenberg LA; Department of Genetics, Stanford University School of Medicine, Stanford, CA 94305-5318, United States.
  • Goss CH; CFFT Therapeutics Development Network Coordinating Center, Seattle, WA. 2001 8th Avenue, Seattle, WA 98121, United States.
  • Tirouvanziam R; Emory+Children's Center for CF and Airways Disease Research, 2015 Uppergate Dr., Rm. 344, Emory University School of Medicine, Atlanta, GA 30322, United States.
J Cyst Fibros ; 14(2): 219-27, 2015 Mar.
Article en En | MEDLINE | ID: mdl-25228446
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 24 weeks. ENDPOINTS: primary, change in sputum human neutrophil elastase (HNE) activity; secondary, FEV(1) 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 (FEV(1) and FEF(25-75%)) remained stable or increased slightly in the NAC group but decreased in the placebo group (p=0.02 and 0.02). Log(10) 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 (24 week FEV1 treatment effect=150 mL, 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Acetilcisteína / Estrés Oxidativo / Fibrosis Quística / Inflamación / Pulmón Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Child / Female / Humans / Male Idioma: En Revista: J Cyst Fibros Año: 2015 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Acetilcisteína / Estrés Oxidativo / Fibrosis Quística / Inflamación / Pulmón Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Child / Female / Humans / Male Idioma: En Revista: J Cyst Fibros Año: 2015 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos