Peripheral Endothelial Function in COPD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of a Peripheral Endothelial Dysfunction in COPD (Chronic Obstructive Pulmonary Disease)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: COPD patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD patients<br>measure of endothelial function with EndoPAT® in COPD patients | Device: COPD patients<br>* measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (EndoPAT®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of reactive hyperemia-peripheral artery tone index | measure of reactive hyperemia-peripheral artery tone index | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of Forced expiratory flow in one second | measure of Forced expiratory flow in one second | day 1 | 
| measure of forced vital capacity | measure of forced vital capacity | day 1 | 
| measure of expiratory flow between 25% and 75% (FEF25-75%). | measure of expiratory flow between 25% and 75% (FEF25-75%). | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, COPD, pulmonary function