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Norwegian Birch Rust Allergy Study (Nor-BRA)

U

University Hospital of North Norway

Status

Completed

Conditions

Hypersensitivity, Immediate

Treatments

Diagnostic Test: Quationnaires and symptom registration
Diagnostic Test: SPT, spesific IgE, pBAT and NPT
Diagnostic Test: PNIF and spirometry

Study type

Observational

Funder types

Other

Identifiers

NCT05661812
272466 (REK)

Details and patient eligibility

About

This study investigates whether spores from birch rust fungi (Melampsoridium Betulinum = MB) may be the eliciting allergen in patients with seasonal airway allergy during autumn in North Norway. Patients with suspected allergy to MB are compared with non-allergic controls using data about allergic disease and daily allergic symptoms during autumn. Potential variations in allergic symptoms during season will be compared with spread of MB spores. Sensitation to MB and MB allergy are to be tested with skin prick test (SPT), measurements of spesific immunglobulin E (IgE) in serum, passive basophil activation test (pBAT) and nasal provocation test (NPT)

Full description

Symptoms of seasonal airway allergy most commonly take place during spring and summertime, normally attributed to pollen from birch or grass. However, some patients in the clinic have experienced and reported typical airway allergy symptoms during autumn, when there is no spread of pollen. The patients report symptoms of allergic rhino-conjunctivitis and/or asthma, and some also tells about worsening in eczema/skin affections.

Birch rust is a disease on birch trees caused by the fungus Melampsoridium Betulinum (MB), and apparently MB spreads in largest amounts in August and September - especially in North Norway.

This study aims to investigate if MB is an allergen causing seasonal airway allergy during autumn in Norway. Both type and severity of symptoms of MB allergy are to be investigated, and also the association between spread of MB spores and symptoms of airway allergy. During the study period there are to be developed MB extracts for skin prick test (SPT), serum specific IgE (sIgE), nasal provocation test (NPT) and passive basophil activation test (BAT), and sensitivity and specificity of SPT, sIgE and BAT will be calculated in comparison to NPT as a gold standard test for allergic rhinitis caused by MB.

Enrollment

287 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Self-reported symptoms of allergic rhinitis, conjunctivitis, allergic asthma and/or exacerbation of eczema in the period from August to October.

Exclusion criteria

  • Perennial airway allergy without worsening of symptoms during autumn.
  • Too long or inadequate distance from home to hospital/testcenter.
  • More than 14 days of absence from Northern Norway during symptomregistration autumn 2022 (August 15 - September 30, 2022).
  • Diseases with persistent manifestations that can interfere or be confused with airway allergic symptoms.
  • Treatment with immunosuppressive drugs.

Trial design

287 participants in 2 patient groups

Patients
Description:
173 patients aged 18-75 years with self-reported allergic airways symptoms during autumn, primarily in August and September.
Treatment:
Diagnostic Test: PNIF and spirometry
Diagnostic Test: SPT, spesific IgE, pBAT and NPT
Diagnostic Test: Quationnaires and symptom registration
Controls
Description:
114 controls aged 18-75, healthy, non-allergic individuals.
Treatment:
Diagnostic Test: PNIF and spirometry
Diagnostic Test: SPT, spesific IgE, pBAT and NPT
Diagnostic Test: Quationnaires and symptom registration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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