The Role of Filaggrin Mutations and Sensitization Pathways in Allergic Rhinitis and Peanut Allergy

NCT02745418 | Active Not Recruiting

• 1 other identifier: FLG-AR-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Caucasian male and female participants age 18 years of age and older will be enrolled in this study if they have known birch or peanut allergies or known to be non-atopic. Participants will undergo skin testing to confirm their allergies if not completed in the last 12 months. Medications and medical history will be captured with a focus on atopic disorders. Participants will undergo birch and peanut patch testing to assess penetration and if potential correlation exists with filaggrin genotyping and phenotyping. Blood samples will be drawn from participants and DNA isolated for genotyping of null mutations in filaggrin.

Conditions

Allergic Rhinitis; Peanut Allergies

Outcome Measures

Primary Outcomes (1)

• Peanut patch testing

  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 Outcomes (1)

• Birch patch testing

  Up to 17 months

Other Outcomes (1)

• Relationship of peanut and birch patch testing responses to filaggrin genotype

  Up to 17 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caucasian male and female participants 18 years of age and older with birch or peanut allergies as well as non-atopic controls will be enrolled in this study.

You may qualify if:

• 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.

You may not qualify if:

• participants unable to complete study related procedures
• participants that have taken or are taking restricted medications

Sponsors & Collaborators

• Dr. Anne Ellis: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L2V7, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected and DNA will be isolated for genotyping of filaggrin mutations.

MeSH Terms

Conditions

Rhinitis, Allergic; Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity; Food Hypersensitivity

Study Officials

• Anne K Ellis, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: April 20, 2016
• Study Start: March 1, 2016
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)