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Peripheral Endothelial Function in Asthmatic Patients

Peripheral Endothelial Function in Asthmatic Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02593344
Acronym
Endothasthm
Enrollment
113
Registered
2015-11-02
Start date
2012-12-13
Completion date
2015-04-09
Last updated
2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Function

Keywords

asthma, endothelial function

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.

Interventions

DEVICEEndopat

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

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
measure of reactive hyperemia-peripheral artery tone indexday 1measure of reactive hyperemia-peripheral artery tone index

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026