Clinical trial NCT02593357: Peripheral Endothelial Function in COPD Patients
Official title: Assessment of a Peripheral Endothelial Dysfunction in COPD (Chronic Obstructive Pulmonary Disease)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: endothelial function
COPD
pulmonary function
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 137
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: measure of reactive hyperemia-peripheral artery tone index
timeFrame: Day 1
Secondary outcomes:
measure: measure of Forced expiratory flow in one second
timeFrame: day 1
measure: measure of forced vital capacity
timeFrame: day 1
measure: measure of expiratory flow between 25% and 75% (FEF25-75%).
timeFrame: day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
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