Peripheral Endothelial Function in Asthmatic Patients

NCT02593344 | Completed

• 1 other identifier: 2012/54
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

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.

Conditions

Endothelial Function

Keywords

asthma, endothelial function

Outcome Measures

Primary Outcomes (1)

• measure of reactive hyperemia-peripheral artery tone index

  measure of reactive hyperemia-peripheral artery tone index

  day 1

Secondary Outcomes (3)

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

  day 1

• measure of the forced vital capacity (FVC)

  day 1

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

  day 1

Study Arms (1)

endopat

EXPERIMENTAL

measure of endothelial function with endopat

Device: Endopat

Interventions

Endopat DEVICE

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

endopat

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (2)

Hôpital Saint Antoine, Pulmonary function test laboratory

Paris, 75012, France

Location

Hôpital Foch Department of pneumology

Suresnes, 92150, France

Location

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Philippe Devillier, MD PhD

  Foch hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: November 2, 2015
• Study Start: December 13, 2012
• Primary Completion: April 9, 2015
• Study Completion: April 9, 2015
• Last Updated: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)