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

Allergy Clinical Trial

— GENEBRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01923519
• Other study ID #: 13-PP-06
• Status: Not yet recruiting
• Phase: N/A
• First received: August 13, 2013
• Last updated: August 13, 2013
• Start date: August 2013

Study information

• Verified date: July 2013
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Charles MARQUETTE, Pr
• Phone: +33 (0)4 92 03 88 83
• Email: marquette.c[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergy

Intervention

Procedure:
• bronchofiberscopy

Locations

Country	Name	City	State
France	Hôpital Pasteur	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genic expression profile of the epithelium		3 months after inclusion	No