NCT00205647已完成2 期
A Phase II Multicenter Efficacy, Safety and Dose-Effect Study of the Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable, Chronic Bronchitis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Acute exacerbations
研究概览
简要总结
This is a randonmized, masked, placebo-controlled parallel group, clinical trial to evaluate the effects of three different doses of N-acetyl L-cysteine (NAC) and placebo on patient safety and on physical and transport properties of expectorated sputum. Patient sumptoms, quality of life and exacerbation will also be followed as well as pulmonary function testing and functional exercise capacity. We hypothesized that a prolongeed course of oral NAC favorably affects the morbidity of chronic bronchitis, particularly the incidence of acute exacerbations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smokers (past or current,20 pack years) with diagnosis of chronic bronchitis
- •expectorate sputum daily
- •FEV1 of 40-70%
- •understand and fill out questionnaire daily
排除标准
- •other investigational within 30 days
- •change in smoking habit within 6 months
- •pulmonary diagnosis other that chronic bronchitis
- •significant renal, cardiac, hepatic or endocrine diseases
- •psychiatric disorder or evidence of alcoholism or drug abuse within year
结局指标
主要结局
Acute exacerbations
Clinical assessments
次要结局
- Functional exercise capacity
- Relationship between mucus physical and transport properties
研究者
研究点 (2)
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