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Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease

This study has been completed.
Sponsor:
Collaborator:
ADPHUN, FRM
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00569361
First received: December 6, 2007
Last updated: June 8, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention
Allergic Rhinitis
 Procedure: Collection of nasal epithelial cells

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups [ Time Frame: At the sample time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Validation with other techniques: Q-PCR [ Time Frame: At the sample time ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: November 2004
Study Completion Date: October 2005
Arms Assigned Interventions
A
Collection of nasal epithelial cells by brushing
 Procedure: Collection of nasal epithelial cells
Collection of nasal epithelial cells by brushing

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).
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569361

Locations
France
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
  More Information

No publications provided by Centre Hospitalier Universitaire de Nice

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Département de la Recherche Clinique et de l'Innovation, CHU de Nice
ClinicalTrials.gov Identifier: NCT00569361     History of Changes
Other Study ID Numbers: CIR 2005
Study First Received: December 6, 2007
Last Updated: June 8, 2009
Health Authority: France: Direction Générale de la Santé
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
allergic rhinitis to dust mite
allergic rhinitis associated with bronchial hyperreactivity
allergic rhinitis associated with asthma

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013