Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease

Allergic Rhinitis Clinical Trial

Official title:

Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569361
• Other study ID #: CIR 2005
• Status: Completed
• Phase: N/A
• First received: December 6, 2007
• Last updated: June 8, 2009
• Start date: November 2004
• Est. completion date: October 2005

Study information

• Verified date: June 2009
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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:

1. allergic rhinitis to dust mite (AR) isolated (n=12),

2. AR associated with bronchial hyperreactivity (n=12),

3. AR associated with asthma (n=14),

4. control (n=14).

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:

1. allergic rhinitis to dust mite (AR) isolated (n=12),

2. AR associated with bronchial hyperreactivity (n=12),

3. AR associated with asthma (n=14),

4. control (n=14).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Procedure:
• Collection of nasal epithelial cells
Collection of nasal epithelial cells by brushing

Locations

Country	Name	City	State
France	Department of Pediatrics, Nice University Hospital	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	ADPHUN, FRM

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups		At the sample time	No
Secondary	Validation with other techniques: Q-PCR		At the sample time	No