Norwegian Birch Rust Allergy Study

Completed

• Conditions: Hypersensitivity, Immediate
• Interventions: Diagnostic Test: Quationnaires and symptom registration; Diagnostic Test: PNIF and spirometry; Diagnostic Test: SPT, spesific IgE, pBAT and NPT

• Registration Number: NCT05661812
• Lead Sponsor: University Hospital of North Norway

Brief Summary

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)

Detailed 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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2022-12-22
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Allergy to birch rust fungi	15 th of August 2022 to 1 st of April 2023.	Evaluate positive sensitization to birch rust by the use of skin prick test, measurement of spesific IgE in blood, passive basofil activation test and nasal provocation test.

Trial Locations

Locations (1)

University hospital North Norway; 🇳🇴 Tromsø, Norway