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NCT Number: NCT04322838

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

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).

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Key information

Conditions

Hypersensitivity, Immediate Allergy Hypersensitivity Immune System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of North Norway

Tromsø, Norway

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self reported seasonal airway allergic symptoms during autumn

Exclusion criteria

  • Perennial airway allergic symptoms without worsening during autumn

Treatment and study plan

MeDALL questionnaire for allergic diseases

Diagnostic Test

Questionnaire about allergic symptoms and disease

Other names: Mechanisms of the development of allergy

Registration of allergic symptoms

Diagnostic Test

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.

Skin prick test

Diagnostic Test

Diagnostic skin test for sensitization to allergens

Specific IgE in serum

Diagnostic Test

Diagnostic test for sensitization to allergens in serum

Other names: IgE

Nasal provocation test

Diagnostic 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 Activation Test

Diagnostic Test

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

Other names: BAT

Primary outcomes

  1. Allergy to Birch rust fungi

    Time frame: 1st of August to 15th of October 2020

    Allergic symptoms during spread of Birch rust spores and positive sensitization and nasal provocation test to birch rust fungi.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Luxembourg Institute of Health
  • Oslo University Hospital

Registry information

Official study title

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.

Acronym: Tro-BRA

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2020
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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