Document Detail


High-dose N-acetylcysteine in stable COPD: the 1-year, double-blind, randomized, placebo-controlled HIACE study.
MedLine Citation:
PMID:  23348146     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Hoi Nam Tse; Luca Raiteri; King Ying Wong; Kwok Sang Yee; Lai Yun Ng; Ka Yan Wai; Ching Kong Loo; Ming Houng Chan
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Chest     Volume:  144     ISSN:  1931-3543     ISO Abbreviation:  Chest     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-07-24     Completed Date:  2013-09-30     Revised Date:  2014-03-06    
Medline Journal Info:
Nlm Unique ID:  0231335     Medline TA:  Chest     Country:  United States    
Other Details:
Languages:  eng     Pagination:  106-18     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01136239
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MeSH Terms
Descriptor/Qualifier:
Acetylcysteine / adverse effects,  therapeutic use*
Aged
Aged, 80 and over
Antioxidants / adverse effects,  therapeutic use*
Asian Continental Ancestry Group*
Dose-Response Relationship, Drug
Double-Blind Method
Dyspnea / epidemiology,  physiopathology
Female
Hong Kong
Humans
Incidence
Male
Middle Aged
Pulmonary Disease, Chronic Obstructive / drug therapy*,  physiopathology*
Questionnaires
Respiratory Function Tests
Treatment Outcome
Walking / physiology
Chemical
Reg. No./Substance:
0/Antioxidants; WYQ7N0BPYC/Acetylcysteine
Comments/Corrections
Comment In:
Chest. 2014 Jan;145(1):193-4   [PMID:  24394845 ]
Chest. 2014 Jan;145(1):194-5   [PMID:  24394846 ]
Praxis (Bern 1994). 2013 Nov 27;102(24):1495-6   [PMID:  24280608 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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