Clinical trial NCT02593344: Peripheral Endothelial Function in Asthmatic Patients
Official title: Peripheral Endothelial Function in Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function
Keywords: asthma, endothelial function
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 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.

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.

Primary outcomes:
measure: measure of reactive hyperemia-peripheral artery tone index
timeFrame: day 1
Secondary outcomes:
measure: measure of the forced expiratory flow in one second (FEV1)
timeFrame: day 1
measure: measure of the forced vital capacity (FVC)
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, Pulmonary function test laboratory
city: Suresnes
country: France
facility: Hôpital Foch Department of pneumology
Study officials:
affiliation: Foch hospital
name: Philippe Devillier, MD PhD
role: PRINCIPAL_INVESTIGATOR
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