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临床试验/NCT00205647
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

Wake Forest University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 1997年1月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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