Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Completed
• CT.gov ID: NCT00569361
• Collaborator: ADPHUN, FRM (Other)
• Enrollment: 80
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 7.3

Study Details

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:

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).

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Procedure: Collection of nasal epithelial cells	N/A

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:

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic
• Study Start Date: Nov 1, 2004
• Actual Study Completion Date: Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Other: A Collection of nasal epithelial cells by brushing	Procedure: Collection of nasal epithelial cells; Collection of nasal epithelial cells by brushing

Outcome Measures

Primary Outcome Measures

1. Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups [At the sample time]

Secondary Outcome Measures

1. Validation with other techniques: Q-PCR [At the sample time]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics, Nice University Hospital	Nice		France	06000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice
• ADPHUN, FRM

Investigators

• Principal Investigator: Marc Albertini, Professor, Department of Pediatrics of Nice University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00569361
• Other Study ID Numbers: CIR 2005
• First Posted: Dec 7, 2007
• Last Update Posted: Jun 9, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: allergic rhinitis to dust mite; allergic rhinitis associated with bronchial hyperreactivity; allergic rhinitis associated with asthma
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic

Study Results

No Results Posted as of Jun 9, 2009