Peripheral Endothelial Function in Asthmatic Patients

Not Applicable

Completed

• Conditions: Endothelial Function
• Interventions: Device: Endopat

• Registration Number: NCT02593344
• Lead Sponsor: Hopital Foch

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.

Study Timeline

• Study Start: 2012-12-13
• Primary Completion: 2015-04-09
• Study Completion: 2015-04-09
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endopat	Endopat	measure of endothelial function with endopat

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 the forced expiratory flow in one second (FEV1)	day 1	measure of the forced expiratory flow in one second (FEV1)
measure of the forced vital capacity (FVC)	day 1	measure of the forced vital capacity (FVC)
measure of expiratory flow between 25% and 75% (FEF25-75%)	day 1	measure of expiratory flow between 25% and 75% (FEF25-75%)

Trial Locations

Locations (2)

Hôpital Saint Antoine, Pulmonary function test laboratory; 🇫🇷 Paris, France

Hôpital Foch Department of pneumology; 🇫🇷 Suresnes, France