Peripheral Endothelial Function in COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— endothBPCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593357
• Other study ID #: 2012/55
• Status: Completed
• Phase: N/A
• Start date: December 17, 2012
• Est. completion date: August 17, 2017

Study information

• Verified date: October 2018
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: August 17, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• COPD patients
measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (EndoPAT®)

Locations

Country	Name	City	State
France	Hôpital Saint-Antoine	Paris
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of reactive hyperemia-peripheral artery tone index	measure of reactive hyperemia-peripheral artery tone index	Day 1
Secondary	measure of Forced expiratory flow in one second	measure of Forced expiratory flow in one second	day 1
Secondary	measure of forced vital capacity	measure of forced vital capacity	day 1
Secondary	measure of expiratory flow between 25% and 75% (FEF25-75%).	measure of expiratory flow between 25% and 75% (FEF25-75%).	day 1