Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05661812
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2022-12-08
Brief Title:
Norwegian Birch Rust Allergy Study
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Norwegian Birch Rust Allergy Study Allergy to Birch Rust Fungi a Possible Explanation to Seasonal Airway Allergy During Autumn
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Nor-BRA
Brief Summary:
This study investigates whether 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 Potential variations in allergic symptoms during season will be compared with spread of MB spores Sensitation to MB and MB allergy are to be tested with skin prick test SPT measurements of spesific immunglobulin E IgE in serum passive basophil activation test pBAT and nasal provocation test NPT
Detailed Description:
Symptoms of seasonal airway allergy most commonly take place during spring and summertime normally attributed to pollen from birch or grass However some patients in the clinic have experienced and reported typical airway allergy symptoms during autumn when there is no spread of pollen The patients report symptoms of allergic rhino-conjunctivitis andor asthma and some also tells about worsening in eczemaskin affections
Birch rust is a disease on birch trees caused by the fungus Melampsoridium Betulinum MB and apparently MB spreads in largest amounts in August and September - especially in North Norway
This study aims to investigate if MB is an allergen causing seasonal airway allergy during autumn in Norway Both type and severity of symptoms of MB allergy are to be investigated and also the association between spread of MB spores and symptoms of airway allergy During the study period there are to be developed MB extracts for skin prick test SPT serum specific IgE sIgE nasal provocation test NPT and passive basophil activation test BAT and sensitivity and specificity of SPT sIgE and BAT will be calculated in comparison to NPT as a gold standard test for allergic rhinitis caused by MB
Birch rust is a disease on birch trees caused by the fungus Melampsoridium Betulinum MB and apparently MB spreads in largest amounts in August and September - especially in North Norway
This study aims to investigate if MB is an allergen causing seasonal airway allergy during autumn in Norway Both type and severity of symptoms of MB allergy are to be investigated and also the association between spread of MB spores and symptoms of airway allergy During the study period there are to be developed MB extracts for skin prick test SPT serum specific IgE sIgE nasal provocation test NPT and passive basophil activation test BAT and sensitivity and specificity of SPT sIgE and BAT will be calculated in comparison to NPT as a gold standard test for allergic rhinitis caused by MB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None