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.
J Cyst Fibros
; 14(2): 219-27, 2015 Mar.
Article
in En
| MEDLINE
| ID: mdl-25228446
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 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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Acetylcysteine
/
Oxidative Stress
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Cystic Fibrosis
/
Inflammation
/
Lung
Type of study:
Clinical_trials
Limits:
Adolescent
/
Adult
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Child
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Female
/
Humans
/
Male
Language:
En
Journal:
J Cyst Fibros
Year:
2015
Document type:
Article
Affiliation country:
Estados Unidos