Peripheral Endothelial Function in COPD Patients

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: COPD patients

• Registration Number: NCT02593357
• Lead Sponsor: Hopital Foch

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-12-17
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Primary Completion: 2017-07-06
• Study Completion: 2017-08-17
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COPD patients	COPD patients	measure of endothelial function with EndoPAT® in COPD patients

Primary Outcome Measures

Name	Time	Method
measure of reactive hyperemia-peripheral artery tone index	Day 1	measure of reactive hyperemia-peripheral artery tone index

Secondary Outcome Measures

Name	Time	Method
measure of forced vital capacity	day 1	measure of forced vital capacity
measure of expiratory flow between 25% and 75% (FEF25-75%).	day 1	measure of expiratory flow between 25% and 75% (FEF25-75%).
measure of Forced expiratory flow in one second	day 1	measure of Forced expiratory flow in one second

Trial Locations

Locations (2)

Hôpital Foch; 🇫🇷 Suresnes, France

Hôpital Saint-Antoine; 🇫🇷 Paris, France