Peripheral Endothelial Function in Asthmatic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the peripheral endothelial function in adult asthmatic 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, 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 level of asthma control (Asthma Control Test (ACT)), the cardiovascular risk factors (SCORE INdex) and the treatment for asthma (controllers) will be also assessed.

Official Title
-----------------
Peripheral Endothelial Function in Asthmatic Patients

Conditions
-----------------
Endothelial Function

Intervention / Treatment
-----------------
* Device: Endopat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients must have a clear-cut history of asthma at the time of enrolment into the trial (eventually confirmed in the past and documented by an increased hyperresponsiveness to methacholine; or a bronchodilator reversibility to a beta-2-adrenergic drug). Exclusion Criteria: Patients with unstable asthma Patients with a significant acute disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial. Pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endopat<br>measure of endothelial function with endopat | Device: Endopat<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?
-----------------
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 the forced expiratory flow in one second (FEV1) | measure of the forced expiratory flow in one second (FEV1) | day 1 | 
| measure of the forced vital capacity (FVC) | measure of the forced vital capacity (FVC) | 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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, endothelial function