Peripheral Endothelial Function in Asthmatic Patients (Endothasthm)

October 1, 2018 updated by: Hopital Foch
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Hôpital Saint Antoine, Pulmonary function test laboratory
      • Suresnes, France, 92150
        • Hôpital Foch Department of pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: endopat
measure of endothelial function with endopat
Device: Endopat
measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (Endopat)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure of reactive hyperemia-peripheral artery tone index
Time Frame: day 1
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)
Time Frame: day 1
measure of the forced expiratory flow in one second (FEV1)
day 1
measure of the forced vital capacity (FVC)
Time Frame: day 1
measure of the forced vital capacity (FVC)
day 1
measure of expiratory flow between 25% and 75% (FEF25-75%)
Time Frame: day 1
measure of expiratory flow between 25% and 75% (FEF25-75%)
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Philippe Devillier, MD PhD, FOCH Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 13, 2012

Primary Completion (ACTUAL)

April 9, 2015

Study Completion (ACTUAL)

April 9, 2015

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (ESTIMATE)

November 1, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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