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Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease

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ClinicalTrials.gov Identifier: NCT00569361
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : June 9, 2009
Sponsor:
Collaborator:
ADPHUN, FRM
Information provided by:
Centre Hospitalier Universitaire de Nice

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : November 2004
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
A
Collection of nasal epithelial cells by brushing
 Procedure: Collection of nasal epithelial cells
Collection of nasal epithelial cells by brushing


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

Secondary Outcome Measures :
  1. Validation with other techniques: Q-PCR [ Time Frame: At the sample time ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569361


Locations
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France
Department of Pediatrics, Nice University Hospital
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
ADPHUN, FRM
Investigators
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Principal Investigator: Marc Albertini, Professor Department of Pediatrics of Nice University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Département de la Recherche Clinique et de l'Innovation, CHU de Nice
ClinicalTrials.gov Identifier: NCT00569361    
Other Study ID Numbers: CIR 2005
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: June 9, 2009
Last Verified: June 2009
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:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases