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

• Conditions: Hypersensitivity, Immediate; Allergy
• Interventions: 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

• Registration Number: NCT04322838
• Lead Sponsor: University Hospital of North Norway

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)

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Study Start: 2020-08-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Self reported seasonal airway allergic symptoms during autumn

Exclusion Criteria

• Perennial airway allergic symptoms without worsening during autumn

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Registration of allergic symptoms	30 patients with self-reported seasonal allergic airway symptoms in the period from 1st of August to 15.th of october
Controls	Skin Prick Test	15 non-allergic individuals
Patients	MeDALL questionnaire for allergic diseases	30 patients with self-reported seasonal allergic airway symptoms in the period from 1st of August to 15.th of october
Patients	Skin Prick Test	30 patients with self-reported seasonal allergic airway symptoms in the period from 1st of August to 15.th of october
Patients	Basophil Activation Test	30 patients with self-reported seasonal allergic airway symptoms in the period from 1st of August to 15.th of october
Controls	MeDALL questionnaire for allergic diseases	15 non-allergic individuals
Controls	Nasal provocation test	15 non-allergic individuals
Patients	Specific IgE in serum	30 patients with self-reported seasonal allergic airway symptoms in the period from 1st of August to 15.th of october
Controls	Registration of allergic symptoms	15 non-allergic individuals
Controls	Basophil Activation Test	15 non-allergic individuals
Patients	Nasal provocation test	30 patients with self-reported seasonal allergic airway symptoms in the period from 1st of August to 15.th of october
Controls	Specific IgE in serum	15 non-allergic individuals

Primary Outcome Measures

Name	Time	Method
Allergy to Birch rust fungi	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.

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsø, Norway