Peripheral Endothelial Function in Asthmatic Patients

Endothelial Function Clinical Trial

— Endothasthm  

Official title:

Peripheral Endothelial Function in Asthmatic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593344
• Other study ID #: 2012/54
• Status: Completed
• Phase: N/A
• Start date: December 13, 2012
• Est. completion date: April 9, 2015

Study information

• Verified date: October 2018
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: April 9, 2015
• Est. primary completion date: April 9, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Function

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Saint Antoine, Pulmonary function test laboratory	Paris
France	Hôpital Foch Department of pneumology	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of reactive hyperemia-peripheral artery tone index	measure of reactive hyperemia-peripheral artery tone index	day 1
Secondary	measure of the forced expiratory flow in one second (FEV1)	measure of the forced expiratory flow in one second (FEV1)	day 1
Secondary	measure of the forced vital capacity (FVC)	measure of the forced vital capacity (FVC)	day 1
Secondary	measure of expiratory flow between 25% and 75% (FEF25-75%)	measure of expiratory flow between 25% and 75% (FEF25-75%)	day 1