- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02745418
The Role of Filaggrin Mutations and Sensitization Pathways in Allergic Rhinitis and Peanut Allergy
Deconstructing the Atopic March - the Role of Filaggrin Mutations and Sensitization Pathways in Allergic Rhinitis and Peanut Allergy
Study Overview
Status
Conditions
Detailed Description
Participants with confirmed history of birch induced allergic rhinitis or peanut allergy or that are non-atopic will undergo the following procedures.
If not already completed in the previous year, participants will be skin tested to a panel of common environmental allergens, including birch pollen and peanut. To be considered "non-atopic", all skin tests in the panel must be negative in the presence of a positive histamine control. All participants will also be skin tested to peanut, Arah 2, Ara h 8 (if obtainable), crushed raw unroasted peanut, peanut butter, peanut extract, Bet v 1 and birch pollen extract.
Blood samples will be drawn for genotyping of the four most common null mutations in FLG in Caucasians (R501X, 2282del4, R2447X, S3247X).
Patch testing will be performed using Ara h2, Arah8 (if obtainable), crushed raw unroasted peanut, peanut butter, peanut extract, Bet v 1 and birch pollen extract. Peanut and birch pollen allergens, both whole and components will be diluted 1:10 in both saline and petroleum jelly and applied to normal controls skin to establish levels for irritant reaction. If further dilutions are required to show non-irritation these will be performed.
As well, a limited medical history and medication history will be documented, with a focus on atopic disorders (i.e. atopic dermatitis (eczema), allergic rhinitis, asthma, and food allergy). Those in the non-allergic control group will be excluded if they have features of eczema, food allergy or other atopic conditions). Medications that could potentially interfere with the skin test results (i.e. antihistamines) must be documented, and appropriate washout intervals observed prior to the skin test procedure, if necessary.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dan E Adams, BSc
- Phone Number: 3944 6135496666
- Email: adamsd@kgh.kari.net
Study Contact Backup
- Name: Lisa M Steacy, BSc
- Phone Number: 3941 6135496666
- Email: lisa.steacy@kingstonhsc.ca
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L2V7
- Recruiting
- Kingston General Hospital
-
Contact:
- Lisa M Steacy, BSc
- Phone Number: 3941 6135496666
- Email: steacyl@kgh.kari.net
-
Contact:
- Dan E Adams, BSc
- Phone Number: 3944 6135496666
- Email: adamsd@kgh.kari.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- caucasian male or females
- participants 18 years of age and older
- participants with known birch allergy, confirmed by a skin test 3mm or greater than the negative control
- participants with diagnosed and confirmed peanut with allergy
- confirmed by one of the following:
- positive food challenge
- convincing history of peanut allergy AND positive skin test (3mm >= than negative control) OR peanut-specific IgE >=0.35
- uncertain history of peanut allergy OR no exposure to peanut AND a positive skin test 5mm>= negative control AND a peanut-specific IgE >=15
- non-allergic controls who lack a diagnosis of any atopic diathesis and have supportive negative skin testing to a panel of common environmental allergens.
Exclusion criteria:
- participants unable to complete study related procedures
- participants that have taken or are taking restricted medications
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peanut patch testing
Time Frame: Up to 17 months
|
Differences in patch test positive responses to peanut allergen (extract plus raw peanut butter preparations) between participants with confirmed peanut allergy, confirmed birch allergy and non-atopic controls. Responses are graded as: Negative (-) Irritant reaction (IR) Equivocal / uncertain (+/-) Weak positive (+) Strong positive (++) Very Strong Positive (+++) |
Up to 17 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Birch patch testing
Time Frame: Up to 17 months
|
Differences in patch test positive responses to birch allergen extract between participants with confirmed peanut allergy, confirmed birch allergy and non-atopic controls. Responses are graded as: Negative (-) Irritant reaction (IR) Equivocal / uncertain (+/-) Weak positive (+) Strong positive (++) Very Strong Positive (+++) |
Up to 17 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship of peanut and birch patch testing responses to filaggrin genotype
Time Frame: Up to 17 months
|
Presence or absence of positive patch tests to birch and peanut and correlation of these responses with filaggrin genotypes.
|
Up to 17 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne K Ellis, MD, Queen's University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Food Hypersensitivity
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Nose Diseases
- Nut and Peanut Hypersensitivity
- Hypersensitivity
- Rhinitis
- Rhinitis, Allergic
- Peanut Hypersensitivity
Other Study ID Numbers
- FLG-AR-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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