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
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Article Info
Publication History
Accepted:
December 24,
2012
Received:
October 3,
2012
Footnotes
Funding/Support: The study was sponsored by the Tung Wah Group of Hospitals Research Fund. Both the N-acetylcysteine and placebo used in this study were manufactured by Zambon Switzerland Ltd and provided by Zambon S.p.A, Bresso, Italy.
Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.
Identification
Copyright
© 2013 The American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
