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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Unknown status

CT.gov ID

NCT01923519

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Allergy	Procedure: bronchofiberscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: allergic rhinitis	Procedure: bronchofiberscopy
Experimental: allergic rhinitis and asthma	Procedure: bronchofiberscopy
Experimental: witnesses	Procedure: bronchofiberscopy

Arm

Intervention/Treatment

Experimental: allergic rhinitis

Procedure: bronchofiberscopy

Experimental: allergic rhinitis and asthma

Procedure: bronchofiberscopy

Experimental: witnesses

Procedure: bronchofiberscopy

Outcome Measures

Primary Outcome Measures

genic expression profile of the epithelium [3 months after inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Pasteur	Nice		France	06003

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT01923519

Other Study ID Numbers:

13-PP-06

First Posted:

Aug 15, 2013

Last Update Posted:

Aug 15, 2013

Last Verified:

Jul 1, 2013

Study Results

No Results Posted as of Aug 15, 2013