High-dose N-acetylcysteine in the prevention of COPD exacerbations: rationale and design of the PANTHEON Study.
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.
State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College, Guangzhou, China. jpzhenggy@163.com
Jin-Ping
JP
Zheng
Fu-Qiang
FQ
Wen
Chun-Xue
CX
Bai
Huan-Ying
HY
Wan
Jian
J
Kang
Ping
P
Chen
Wan-Zhen
WZ
Yao
Li-Jun
LJ
Ma
Qi-Kui
QK
Xia
Yi
Y
Gao
Nan-Shan
NS
Zhong
D000111:Acetylcysteine / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018450:Disease Progression; D004311:Double-Blind Method; D005100:Expectorants / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000503:physiopathology / Q000517:prevention & control*; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D014797:Vital Capacity
D005100:Expectorants; D000111:Acetylcysteine