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.
Study design (if review, criteria of inclusion for studies)
Multicenter, randomized, double-blind proof of concept study
Participants
70 CF subjects
Interventions
NAC or placebo orally thrice daily for 24weeks.
Outcome measures
Primary endpoint: 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.
Main 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).
Authors' 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.
Keywords: Acetylcysteine; Airway clearance drugs -expectorants- mucolytic- mucociliary-; Inhalation OR nebulised; N Acetylcysteine; pharmacological_intervention; Combined Modality Therapy; Oral; Respiratory System Agents; Nacystelyn;