search
Back to results

Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of nasal epithelial cells
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Allergic Rhinitis focused on measuring allergic rhinitis to dust mite, allergic rhinitis associated with bronchial hyperreactivity, allergic rhinitis associated with asthma

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients:

  • Patients between 6 and 17 years old
  • Patients with allergic rhinitis

Witness:

  • Patients between 6 and 17 years old
  • Patients without allergic rhinitis and asthma

Exclusion Criteria:

  • Rhino-bronchitis infection dated from less than 15 days
  • Patients younger than 6 or older than 17 years

Sites / Locations

  • Department of Pediatrics, Nice University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A

Arm Description

Collection of nasal epithelial cells by brushing

Outcomes

Primary Outcome Measures

Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups

Secondary Outcome Measures

Validation with other techniques: Q-PCR

Full Information

First Posted
December 6, 2007
Last Updated
June 8, 2009
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
ADPHUN, FRM
search

1. Study Identification

Unique Protocol Identification Number
NCT00569361
Brief Title
Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease
Official Title
Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
ADPHUN, FRM

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Using a human pangenomic microarray, the researchers established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct groups: allergic rhinitis to dust mite (AR) isolated (n=12), AR associated with bronchial hyperreactivity (n=12), AR associated with asthma (n=14), control (n=14).
Detailed Description
Context: Asthma is the most frequent chronic disease in childhood. Allergic rhinitis has been described as a risk factor to develop asthma. The objective of the study was to evaluate the contribution of the respiratory epithelium to development of allergic rhinitis and asthma and to identify the molecular mechanisms driving rhinitis toward asthma. Methods: Using a human pangenomic microarray, we established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct children 2 to 18 years of age groups: allergic rhinitis to dust mite (AR) isolated (n=12), AR associated with bronchial hyperreactivity (n=12), AR associated with asthma (n=14), control (n=14).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
allergic rhinitis to dust mite, allergic rhinitis associated with bronchial hyperreactivity, allergic rhinitis associated with asthma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Collection of nasal epithelial cells by brushing
Intervention Type
Procedure
Intervention Name(s)
Collection of nasal epithelial cells
Intervention Description
Collection of nasal epithelial cells by brushing
Primary Outcome Measure Information:
Title
Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups
Time Frame
At the sample time
Secondary Outcome Measure Information:
Title
Validation with other techniques: Q-PCR
Time Frame
At the sample time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients: Patients between 6 and 17 years old Patients with allergic rhinitis Witness: Patients between 6 and 17 years old Patients without allergic rhinitis and asthma Exclusion Criteria: Rhino-bronchitis infection dated from less than 15 days Patients younger than 6 or older than 17 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Albertini, Professor
Organizational Affiliation
Department of Pediatrics of Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22005912
Citation
Giovannini-Chami L, Marcet B, Moreilhon C, Chevalier B, Illie MI, Lebrigand K, Robbe-Sermesant K, Bourrier T, Michiels JF, Mari B, Crenesse D, Hofman P, de Blic J, Castillo L, Albertini M, Barbry P. Distinct epithelial gene expression phenotypes in childhood respiratory allergy. Eur Respir J. 2012 May;39(5):1197-205. doi: 10.1183/09031936.00070511. Epub 2011 Oct 17.
Results Reference
derived

Learn more about this trial

Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease

We'll reach out to this number within 24 hrs