Clinical trial NCT05661812: Norwegian Birch Rust Allergy Study
Official title: Norwegian Birch Rust Allergy Study. Allergy to Birch Rust Fungi, a Possible Explanation to Seasonal Airway Allergy During Autumn?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersensitivity, Immediate
Keywords: Birch rust fungi
Melampsoridium Betulinum
Allergy
Allergic rhino-conjunctivitis
Allergic asthma
Eczema
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Luxembourg Institute of Health
name: Oslo University Hospital
First posted: 2022-12-22
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with allergic symptoms of rhino-conjunctivitis and/or asthma and/or eczema in the period from August 1 to October 15.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Allergy to birch rust fungi
timeFrame: 15 th of August 2022 to 1 st of April 2023.
measure: Allergy to birch rust fungi
timeFrame: 15 th of August 2022 to 1 st of April 2023.
measure: Allergy to birch rust fungi
timeFrame: 15 th of August 2022 to 1 st of April 2023.
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University hospital North Norway
Study officials:
affiliation: University Hospital of North Norway
name: Martin Sørensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Croce MA, da Costa Manso ER, Gambale W, Takayama L, Oliveira Andrade CE, Pereira Pinto JH, Morato Castro FF, Croce J. Sensitization to the fungus Hemileia vastatrix (coffee leaf rust). Allergy. 2001 Jul;56(7):684-7. doi: 10.1034/j.1398-9995.2001.00053.x.
citation: Simon-Nobbe B, Denk U, Poll V, Rid R, Breitenbach M. The spectrum of fungal allergy. Int Arch Allergy Immunol. 2008;145(1):58-86. doi: 10.1159/000107578. Epub 2007 Aug 20.
citation: Horner WE, Lopez M, Salvaggio JE, Lehrer SB. Basidiomycete allergy: identification and characterization of an important allergen from Calvatia cyathiformis. Int Arch Allergy Appl Immunol. 1991;94(1-4):359-61. doi: 10.1159/000235403.
citation: Das, S. and D. Gupta, Environmental and occupational respiratory diseases - 1033. Rust fungi of plants and high IgE levels in asymptomatic workers of a stored food grains godown: a possible relationship. World Allergy Organ J, 2013. 6(Suppl 1): p. P32.
citation: Hohmann C, Pinart M, Tischer C, Gehring U, Heinrich J, Kull I, Melen E, Smit HA, Torrent M, Wijga AH, Wickman M, Bachert C, Lodrup Carlsen KC, Carlsen KH, Bindslev-Jensen C, Eller E, Esplugues A, Fantini MP, Annesi-Maesano I, Momas I, Porta D, Vassilaki M, Waiblinger D, Sunyer J, Anto JM, Bousquet J, Keil T; MeDALL Study Group. The development of the MeDALL Core Questionnaires for a harmonized follow-up assessment of eleven European birth cohorts on asthma and allergies. Int Arch Allergy Immunol. 2014;163(3):215-24. doi: 10.1159/000357732. Epub 2014 Mar 1.