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Completed

NCT Number: NCT02593344

Peripheral Endothelial Function in Asthmatic Patients

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.

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Key information

Conditions

Endothelial Function Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint Antoine, Pulmonary function test laboratory, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EndoPAT

Device

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

Primary outcomes

  1. measure of reactive hyperemia-peripheral artery tone index

    Time frame: day 1

    measure of reactive hyperemia-peripheral artery tone index

Secondary outcomes

  1. measure of the forced expiratory flow in one second (FEV1)

    Time frame: day 1

    measure of the forced expiratory flow in one second (FEV1)

  2. measure of the forced vital capacity (FVC)

    Time frame: day 1

    measure of the forced vital capacity (FVC)

  3. measure of expiratory flow between 25% and 75% (FEF25-75%)

    Time frame: day 1

    measure of expiratory flow between 25% and 75% (FEF25-75%)

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: Endothasthm

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 2, 2015
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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