Study of Genic Expression Profiles of the Epithelium of the Nose and Bronchi in Healthy and Allergic Subjects (GENEBRO)

August 13, 2013 updated by: Centre Hospitalier Universitaire de Nice
The respiratory epithelium plays a leading role in the development of allergic respiratory disease with barrier function alteration, its repair mechanisms, of anti-viral fight and the ability to induce by itself Th2 responses. The majority of allergic asthmatic patients have reached concomitant ENT: the concept of "one airway, one disease." Access to this material of epithelial study in the different phenotypes of the disease appears to be crucial. Nasal and bronchial epithelial tissues reveal essential differences in particular related to their environment (remodeling less intense and a lower sensitivity to the virus in the nose), but they nevertheless share many common cellular characteristics.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Locations

  • France
      • Nice, France, 06003
        • Hôpital Pasteur
        • Contact:
        • Principal Investigator:
          • Charles MARQUETTE, Pr

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 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥ 18 years and <30 years
  • isolated allergic rhinitis according to clinical criteria ARIA
  • absence of asthma whose diagnosis is made based on clinical criteria or mild to moderate persistent asthma controlled with a diagnosis is made based on clinical criteria

Exclusion Criteria:

  • recent rhino-bronchial infection (<6 weeks)
  • asthma exacerbation in the previous 6 weeks
  • Chronic disease may in the opinion of the investigators interfere with the results of the study or expose them to additional risk.
  • Treatment with nasal corticosteroids, inhaled or systemic in the past 6 weeks
  • Current smoking no history of smoking or not smoking for at least 12 months and weaned smoking history <5 pack-years)
  • Special Needs

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: allergic rhinitis
Procedure: bronchofiberscopy
EXPERIMENTAL: allergic rhinitis and asthma
Procedure: bronchofiberscopy
EXPERIMENTAL: witnesses
Procedure: bronchofiberscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
genic expression profile of the epithelium
Time Frame: 3 months after inclusion
3 months after inclusion

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

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

August 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2015

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (ESTIMATE)

August 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 13, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 13-PP-06

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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