Viewing Study NCT04322838



Ignite Creation Date: 2024-05-06 @ 2:27 PM
Last Modification Date: 2024-10-26 @ 1:31 PM
Study NCT ID: NCT04322838
Status: UNKNOWN
Last Update Posted: 2021-04-28
First Post: 2020-03-24

Brief Title: Tromsø Birch Rust Allergy Study Allergy to Birch Rust a Possible Explanation to Seasonal Airway Allergy During Autumn
Sponsor: University Hospital of North Norway
Organization: University Hospital of North Norway

Study Overview

Official 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
Status: UNKNOWN
Status Verified Date: 2021-04
Last Known Status: RECRUITING
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: Tro-BRA
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 LiH9-12 and BAT by Oslo University hospital 13-14

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