Assessment of a Peripheral Endothelial Dysfunction in COPD (Chronic Obstructive Pulmonary Disease)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- measure of reactive hyperemia-peripheral artery tone index
研究概览
简要总结
The aim of the study is to assess the peripheral endothelial function in adult COPD (chronic obstructive pulmonary disease) patients and the relationship between the peripheral endothelial function and the pulmonary function.
详细描述
The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the FEV1 (forced expiratory volume in one second), the forced vital capacity (FVC) and the expiratory flow between 25% and 75% (FEF25-75%). The relationship between these parameters of the pulmonary function and the peripheral endothelial function will be analyzed. In addition, a relationship between peripheral endothelial function and the severity of COPD (classification according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2010 and GOLD 2011 and the COPD assessment test, the cardiovascular risk factors (SCORE INdex) and the smoker status will be also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COPD : FEV1/FVC < 70%
- •Smokers or ex-smokers ( ≥ 10 pack-years)
- •No COPD exacerbation in the last three months
- •No history of asthma and no respiratory allergy
排除标准
- •Pregnant or nursing women
- •Treatment with pulmonary vasodilators
- •Patients with a significant acute disease. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
研究组 & 干预措施
COPD patients
measure of endothelial function with EndoPAT® in COPD patients
干预措施: COPD patients (Device)
结局指标
主要结局
measure of reactive hyperemia-peripheral artery tone index
时间窗: Day 1
measure of reactive hyperemia-peripheral artery tone index
次要结局
- measure of forced vital capacity(day 1)
- measure of expiratory flow between 25% and 75% (FEF25-75%).(day 1)
- measure of Forced expiratory flow in one second(day 1)