High-dose N-acetylcysteine in the prevention of COPD exacerbations: rationale and
design of the PANTHEON Study.
Author(s): Zheng JP(1), Wen FQ, Bai CX, Wan HY, Kang J, Chen P, Yao WZ, Ma LJ, Xia QK, Gao
Y, Zhong NS; PANTHEON study committee.
Affiliation(s): Author information:
(1)State Key Laboratory of Respiratory Disease, First Affiliated Hospital of
Guangzhou Medical College, Guangzhou, China. jpzhenggy@163.com
Publication date & source: 2013, COPD. , 10(2):164-71
Chronic obstructive pulmonary disease (COPD) is characterized by persistent
airflow limitation; from a pathophysiological point of view it involves many
components, including mucus hypersecretion, oxidative stress and inflammation.
N-acetylcysteine (NAC) is a mucolytic agent with antioxidant and
anti-inflammatory properties. Long-term efficacy of NAC 600mg/d in COPD is
controversial; a dose-effect relationship has been demonstrated, but at present
it is not known whether a higher dose provides clinical benefits. The PANTHEON
Study is a prospective, ICS stratified, randomized, double-blind,
placebo-controlled, parallel-group, multi-center trial designed to assess the
efficacy and safety of high-dose (1200 mg/daily) NAC treatment for one year in
moderate-to-severe COPD patients. The primary endpoint is the annual exacerbation
rate. Secondary endpoints include recurrent exacerbations hazard ratio, time to
first exacerbation, as well as quality of life and pulmonary function. The
hypothesis, design and methodology are described and baseline characteristics of
recruited patients are presented. 1006 COPD patients (444 treated with
maintenance ICS, 562 ICS naive, aged 66.27±8.76 yrs, average post-bronchodilator
FEV1 48.95±11.80 of predicted) have been randomized at 34 hospitals in China.
Final results of this study will provide objective data on the effects of
high-dose (1200 mg/daily) long-term NAC treatment in the prevention of COPD
exacerbations and other outcome variables.
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