Allergic RhinitisNCT00569361
Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease
A study testing Collection of nasal epithelial cells in people with Allergic Rhinitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Collection of nasal epithelial cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2004to Oct 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Rhino-bronchitis infection dated from less than 15 days
- Patients younger than 6 or older than 17 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- allergic rhinitis to dust mite (AR) isolated (n=12),
- AR associated with bronchial hyperreactivity (n=12),
- AR associated with asthma (n=14),
- control (n=14).
Read the 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:
- allergic rhinitis to dust mite (AR) isolated (n=12),
- AR associated with bronchial hyperreactivity (n=12),
- AR associated with asthma (n=14),
- control (n=14).
- Conditions
- Allergic Rhinitis
- Being tested
- Collection of nasal epithelial cells
- Keywords
- allergic rhinitis to dust mite, allergic rhinitis associated with bronchial hyperreactivity, allergic rhinitis associated with asthma
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of nasal epithelial cellsProcedure or surgery
Collection of nasal epithelial cells by brushing
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Collection of nasal epithelial cells by brushing Receives: Procedure: Collection of nasal epithelial cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups
Measured: At the sample time
Secondary outcomes (1)
Validation with other techniques: Q-PCR
Measured: At the sample time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startNov 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- ADPHUN, FRM
- Investigators
- Marc Albertini, Professor, Principal investigator, Department of Pediatrics of Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569361
- Sponsor's protocol ID
- CIR 2005
- Status last verified
- Jun 2009
- First submitted
- 6 Dec 2007
- Last updated
- 9 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Giovannini-Chami L, Marcet B, Moreilhon C, Chevalier B, Illie MI, Lebrigand K, Robbe-Sermesant K, Bourrier T, Michiels JF, Mari B, Crenesse D, Hofman P, de Blic J, Castillo L, Albertini M, Barbry P. Distinct epithelial gene expression phenotypes in childhood respiratory allergy. Eur Respir J. 2012 May;39(5):1197-205. doi: 10.1183/09031936.00070511. Epub 2011 Oct 17.
PubMed 22005912
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic
- ClinicalTrials.gov ID
- NCT00569361
- Acronym / sponsor ID
- CIR 2005
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis to dust mite, allergic rhinitis associated with bronchial hyperreactivity, allergic rhinitis associated with asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- ADPHUN, FRM
- Study start
- Nov 2004
- Study completion
- Oct 2005 (actual)
- First posted
- 7 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- allergic rhinitis to dust mite (AR) isolated (n=12),
- AR associated with bronchial hyperreactivity (n=12),
- AR associated with asthma (n=14),
- control (n=14).
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:
- allergic rhinitis to dust mite (AR) isolated (n=12),
- AR associated with bronchial hyperreactivity (n=12),
- AR associated with asthma (n=14),
- control (n=14).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: Collection of nasal epithelial cellsCollection of nasal epithelial cells by brushing |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients between 6 and 17 years old
- Patients with allergic rhinitis
- Patients between 6 and 17 years old
- Patients without allergic rhinitis and asthma
Key exclusion criteria (2 listed)
- Rhino-bronchitis infection dated from less than 15 days
- Patients younger than 6 or older than 17 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of nasal epithelial cellsCollection of nasal epithelial cells by brushing | Procedure or surgery | A |
Primary outcome
Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups
Time frame: At the sample time
1 secondary outcome
Validation with other techniques: Q-PCR
Time frame: At the sample time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2009.
- Derived from this study: PubMed 22005912Giovannini-Chami L, Marcet B, Moreilhon C, Chevalier B, Illie MI, Lebrigand K, Robbe-Sermesant K, Bourrier T, Michiels JF, Mari B, Crenesse D, Hofman P, de Blic J, Castillo L, Albertini M, Barbry P. Distinct epithelial gene expression phenotypes in childhood respiratory allergy. Eur Respir J. 2012 May;39(5):1197-205. doi: 10.1183/09031936.00070511. Epub 2011 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Albertini, Professor principal investigator
Department of Pediatrics of Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of nasal epithelial cells in people with Allergic Rhinitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups (time frame: At the sample time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00569361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2009.