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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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.

Conditions
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Hypersensitivity, Immediate, Allergy

Intervention / Treatment
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* Diagnostic Test: MeDALL questionnaire for allergic diseases
* Diagnostic Test: Registration of allergic symptoms
* Diagnostic Test: Skin Prick Test
* Diagnostic Test: Specific IgE in serum
* Diagnostic Test: Nasal provocation test
* Diagnostic Test: Basophil Activation Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self reported seasonal airway allergic symptoms during autumn Exclusion Criteria: Perennial airway allergic symptoms without worsening during autumn

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>30 patients with self-reported seasonal allergic airway symptoms in the period from 1st of August to 15.th of october | Diagnostic Test: MeDALL questionnaire for allergic diseases<br>* Questionnaire about allergic symptoms and disease<br>* Other names: Mechanisms of the development of allergy;Diagnostic Test: Registration of allergic symptoms<br>* 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.<br>Diagnostic Test: Skin Prick Test<br>* Diagnostic skin test for sensitization to allergens<br>Diagnostic Test: Specific IgE in serum<br>* Diagnostic test for sensitization to allergens in serum<br>* Other names: IgE;Diagnostic Test: Nasal provocation test<br>* 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)<br>Diagnostic Test: Basophil Activation Test<br>* Basophil leukocytes are extracted from full blood and exposed to 6 different doses of allergen and activation of basophils are measured.<br>* Other names: BAT;|
| Controls<br>15 non-allergic individuals | Diagnostic Test: MeDALL questionnaire for allergic diseases<br>* Questionnaire about allergic symptoms and disease<br>* Other names: Mechanisms of the development of allergy;Diagnostic Test: Registration of allergic symptoms<br>* 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.<br>Diagnostic Test: Skin Prick Test<br>* Diagnostic skin test for sensitization to allergens<br>Diagnostic Test: Specific IgE in serum<br>* Diagnostic test for sensitization to allergens in serum<br>* Other names: IgE;Diagnostic Test: Nasal provocation test<br>* 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)<br>Diagnostic Test: Basophil Activation Test<br>* Basophil leukocytes are extracted from full blood and exposed to 6 different doses of allergen and activation of basophils are measured.<br>* Other names: BAT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergy to Birch rust fungi | Allergic symptoms during spread of Birch rust spores and positive sensitization and nasal provocation test to birch rust fungi. | 1st of August to 15th of October 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Birch rust fungi, Melampsoridium Betulinum, Allergy, Allergic rhino-conjunctivitis, Allergic asthma