High-dose N-acetylcysteine in stable COPD: the 1-year, double-blind, randomized, placebo-controlled HIACE study
- PMID: 23348146
- DOI: 10.1378/chest.12-2357
High-dose N-acetylcysteine in stable COPD: the 1-year, double-blind, randomized, placebo-controlled HIACE study
Abstract
Background: The mucolytic and antioxidant effects of N-acetylcysteine (NAC) may have great value in COPD treatment. However, beneficial effects have not been confirmed in clinical studies, possibly due to insufficient NAC doses and/or inadequate outcome parameters used. The objective of this study was to investigate high-dose NAC plus usual therapy in Chinese patients with stable COPD.
Methods: The 1-year HIACE (The Effect of High Dose N-acetylcysteine on Air Trapping and Airway Resistance of Chronic Obstructive Pulmonary Disease-a Double-blinded, Randomized, Placebo-controlled Trial) double-blind trial conducted in Kwong Wah Hospital, Hong Kong, randomized eligible patients aged 50 to 80 years with stable COPD to NAC 600 mg bid or placebo after 4-week run-in. Lung function parameters, symptoms, modified Medical Research Council (mMRC) dyspnea and St. George's Respiratory Questionnaire (SGRQ) scores, 6-min walking distance (6MWD), and exacerbation and admission rates were measured at baseline and every 16 weeks for 1 year.
Results: Of 133 patients screened, 120 were eligible (93.2% men; mean age, 70.8±0.74 years; %FEV1 53.9±2.0%). Baseline characteristics were similar in the two groups. At 1 year, there was a significant improvement in forced expiratory flow 25% to 75% (P=.037) and forced oscillation technique, a significant reduction in exacerbation frequency (0.96 times/y vs 1.71 times/y, P=.019), and a tendency toward reduction in admission rate (0.5 times/y vs 0.8 times/y, P=.196) with NAC vs placebo. There were no significant between-group differences in mMRC dypsnea score, SGRQ score, and 6MWD. No major adverse effects were reported.
Conclusion: In this study, 1-year treatment with high-dose NAC resulted in significantly improved small airways function and decreased exacerbation frequency in patients with stable COPD.
Trial registry: ClinicalTrials.gov; No.: NCT01136239; URL: www.clinicaltrials.gov.
Comment in
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[N-acetylcysteine reduces exacerbation frequency in COPD].Praxis (Bern 1994). 2013 Nov 27;102(24):1495-6. doi: 10.1024/1661-8157/a001481. Praxis (Bern 1994). 2013. PMID: 24280608 German. No abstract available.
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N-Acetylcysteine Protection in COPD: An Alternative Mechanism of Action.Chest. 2014 Jan;145(1):193-4. doi: 10.1378/chest.13-2029. Chest. 2014. PMID: 24394845 No abstract available.
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Response.Chest. 2014 Jan;145(1):194-195. doi: 10.1378/chest.13-2620. Chest. 2014. PMID: 24394846 Free PMC article. No abstract available.
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High-dose N-acetylcysteine in chronic obstructive pulmonary disease, prone positioning in acute respiratory distress syndrome, and continuous positive airway pressure and exhaled nitric oxide in obstructive sleep apnea.Am J Respir Crit Care Med. 2014 Jan 15;189(2):223-4. doi: 10.1164/rccm.201308-1555RR. Am J Respir Crit Care Med. 2014. PMID: 24428648 Free PMC article. No abstract available.
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