An observational study in Hypersensitivity, Immediate and Allergy, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by University Hospital of North Norway · Observational
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).
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)
82 studies on the registry are indexed under Hypersensitivity, Immediate; 7 are open to participants now.
This study's enrollment of 48 is below the median of 159 across 11 observational studies indexed under Hypersensitivity, Immediate.
Browse Hypersensitivity, Immediate studies →University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
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Patients with allergic symptoms of allergic rhino-conjunctivitis and/or allergic asthma in the period from 1st of august to 15th of October.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · 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
15 non-allergic individuals
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
Questionnaire about allergic symptoms and disease
Also known as: Mechanisms of the development of allergy
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 skin test for sensitization to allergens
Diagnostic test for sensitization to allergens in serum
Also known as: IgE
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.
Also known as: BAT
Allergy to Birch rust fungi
Allergic symptoms during spread of Birch rust spores and positive sensitization and nasal provocation test to birch rust fungi.
Time frame: 1st of August to 15th of October 2020
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will be available within 6 months of study completion.
Access criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.
Ran from Aug 2020 to primary completion in Jun 2026, 70 months.
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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