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Tromsø Birch Rust Allergy Study. Allergy to Birch Rust, a Possible Explanation to Seasonal Airway Allergy During Autumn?

Tromsø Birch Rust Allergy Study. Allergy to Birch Rust Fungi, a Possible Explanation to Seasonal Airway Allergy During Autumn? A Pilot Study With 30 Patients With Suspected Allergy to Birch Rust and 15 Non-allergic Controls.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04322838
Acronym
Tro-BRA
Enrollment
45
Registered
2020-03-26
Start date
2020-08-01
Completion date
2021-12-01
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity, Immediate, Allergy

Keywords

Birch rust fungi, Melampsoridium Betulinum, Allergy, Allergic rhino-conjunctivitis, Allergic asthma

Brief summary

In this project we study if 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. Daily spread of MB spores are compared with daily variations in allergic symptoms. Sensitization to MB and MB allergy are tested with skin prick test, specific immunoglobulin E (IgE) in serum, nasal provocation test and basophil activation test (BAT).

Detailed description

It is unknown why patients experience seasonal airway allergy during autumn in Norway, when there is no spread of pollen. Some old studies indicate that rust fungi on other plants may act as allergens to humans (1-6). In Norway, some patients report typical symptoms of allergic rhino-conjunctivitis and asthma from August to October which stops when temperature falls below zero (Celsius). Based on several patient experiences we hypothesize that MB may cause seasonal airway allergy during autumn. In this pilot study we will compare 30 patients with suspected allergy to MB with a control group of 15 non-allergic individuals. All 45 participants will answer the MeDALL (mechanisms of the development of allergy) questionnaire (7) about allergic diseases and daily register allergic symptoms (8) in the period from 1st of August to 15th of October 2020. Daily variations in symptoms will be compared with daily variations in spread of MB spores registered in pollen traps. Sensitization to MB will be tested with skin prick test and specific IgE in serum and allergy to MB with nasal provocation test and basophil activation test (BAT). Identification of allergens and production of MB extracts for testing will be performed by Luxembourg institute of Health (LiH)(9-12) and BAT by Oslo University hospital (13-14)

Interventions

DIAGNOSTIC_TESTMeDALL questionnaire for allergic diseases

Questionnaire about allergic symptoms and disease

DIAGNOSTIC_TESTRegistration of allergic symptoms

Daily registration of allergic symptoms from eyes, nose and lungs on scale from 0-10 and daily registration of use of anti allergic medication from 1st of August to 15th of October.

DIAGNOSTIC_TESTSkin Prick Test

Diagnostic skin test for sensitization to allergens

DIAGNOSTIC_TESTSpecific IgE in serum

Diagnostic test for sensitization to allergens in serum

DIAGNOSTIC_TESTNasal provocation test

Diagnostic test for allergic rhinitis. Patients and controls are exposed to an allergen with a nasal spray. Allergic reactions are measured with Linder score and Pean Nasal Inspiratory Flow (PNIF)

Basophil leukocytes are extracted from full blood and exposed to 6 different doses of allergen and activation of basophils are measured.

Sponsors

Luxembourg Institute of Health
CollaboratorOTHER_GOV
Oslo University Hospital
CollaboratorOTHER
University Hospital of North Norway
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Self reported seasonal airway allergic symptoms during autumn

Exclusion criteria

* Perennial airway allergic symptoms without worsening during autumn

Design outcomes

Primary

MeasureTime frameDescription
Allergy to Birch rust fungi1st of August to 15th of October 2020Allergic symptoms during spread of Birch rust spores and positive sensitization and nasal provocation test to birch rust fungi.

Countries

Norway

Contacts

Primary ContactMartin Sørensen, PhD
martin.sorensen@unn.no+4790107879
Backup ContactElin Ørbeck Vallevik, MD
elin.orbeck.vallevik@unn.no+4741645961

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026