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Completed

NCT Number: NCT02593357

Peripheral Endothelial Function in COPD Patients

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint-Antoine, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

COPD patients

Device

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

Primary outcomes

  1. measure of reactive hyperemia-peripheral artery tone index

    Time frame: Day 1

    measure of reactive hyperemia-peripheral artery tone index

Secondary outcomes

  1. measure of Forced expiratory flow in one second

    Time frame: day 1

    measure of Forced expiratory flow in one second

  2. measure of forced vital capacity

    Time frame: day 1

    measure of forced vital capacity

  3. measure of expiratory flow between 25% and 75% (FEF25-75%).

    Time frame: day 1

    measure of expiratory flow between 25% and 75% (FEF25-75%).

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: endothBPCO

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2015
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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