Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease

June 8, 2009 updated by: Centre Hospitalier Universitaire de Nice

Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Department of Pediatrics, Nice University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups
Time Frame: At the sample time
At the sample time

Secondary Outcome Measures

Outcome Measure
Time Frame
Validation with other techniques: Q-PCR
Time Frame: At the sample time
At the sample time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Collaborators

ADPHUN, FRM

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 6, 2007

First Posted (Estimate)

December 7, 2007

Study Record Updates

Last Update Posted (Estimate)

June 9, 2009

Last Update Submitted That Met QC Criteria

June 8, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIR 2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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