EUCTR2007-003946-13-BE进行中（未招募）不适用
Double blind, randomized, placebo-controlled, two-way crossover, pilot study to assess the effect of high dose N acetylcysteine on small airways and on inflammation and oxidative stress in COPD patients
niversity Hospital Antwerp; Department Respiratory Medicine0 个研究点开始时间: 2007年8月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients with documented COPD based on the following criteria:
- •Smoking history of at least 10 pack-years
- •Decreased Tiffeneau index (FEV1/(FVC < 0.70)
- •2.Patients aged = 40 years
- •3.Patients who stopped smoking since more than 1 month
- •4.Patients who present moderate COPD with an FEV1 between 50 and 80% of predicted (GOLD 2)
- •5.Patients should be treated according to GOLD guidelines
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Unstable patients who developed an exacerbation during the last 8 weeks
- •2.Patients who are current smokers or stopped less than 1 month
- •3.Patients who are allergic to acetylcysteine or to another element of the product
- •4.Patients with phenylketonurie or an untreated active peptic ulcer
- •5.Patients with any stage kidney and/or heart insufficiency or hypertension
- •6.Patients already treated with NAC for more than 6 months or during the last 3 months
- •7.Patients on continuous treatment with oral, inhalation, intravenous or intramuscular corticosteroids
- •8.Patients who are pregnant or are breast-feeding
- •9.Patients who are treated with orally administered cefalosporines
- •10.Patients using supplements containing antioxidants as vitamins C or E
研究者
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