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临床试验/EUCTR2005-003651-12-ES
EUCTR2005-003651-12-ES进行中(未招募)1 期

AC EFFECT ON OXIDATIVE STRESS AND MUSCLE FUNCTION IN COPD PATIENTS.Efecto de NAC en estrés oxidativo y función muscular en pacientes con EPOC

ZAMBON, S.A.0 个研究点目标入组 0 人开始时间: 2005年9月23日最近更新:
适应症
相关药物

试验速览

阶段
1 期
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
Male

入选标准

  • This study will include 30 male ex-smokers between 18-65 years with stable severe COPD, (FEV1/FVC<70%, FEV1<50% predicted) as defined by the Global Initiative for chronic Obstructive Lung Disease guidelines.
  • Informed written consent will be obtained.
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Exclusion criteria will be unstable COPD (i.e., exacerbation in the last 2 months), long-term supplemental oxygen and NAC treatment, neuromuscular disease, cardiac failure, diabetes mellitus, arthritis, phenylcetonuria, vascular disease and alcoholism or with a clinical condition or relevant analytical alterations. None of the patients can take systemic oral steroid medication in the 6 months before the study, and all medication regimens remained unchanged during the study period. Will be excluded supplementation with antioxidants or vitamins.
  • Also patients with NAC allergy will be excluded.

研究者

发起方
ZAMBON, S.A.

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