Hypersensitivity, ImmediateTro-BRANCT04322838
Tromsø Birch Rust Allergy Study. Allergy to Birch Rust, a Possible Explanation to Seasonal Airway Allergy During Autumn?
An observational study of Hypersensitivity, Immediate and Allergy, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypersensitivity, Immediate, Allergy
- What is being tested?
- MeDALL questionnaire for allergic diseases, Registration of allergic symptoms and Skin Prick Test
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2020to 16 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with allergic symptoms of allergic rhino-conjunctivitis and/or allergic asthma in the period from 1st of august to 15th of October.
Who may be able to join
- Self reported seasonal airway allergic symptoms during autumn
Who cannot join
- Perennial airway allergic symptoms without worsening during autumn
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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)
- Conditions
- Hypersensitivity, Immediate, Allergy
- Being tested
- MeDALL questionnaire for allergic diseases, Registration of allergic symptoms, Skin Prick Test, Specific IgE in serum, Nasal provocation test
- Keywords
- Birch rust fungi, Melampsoridium Betulinum, Allergy, Allergic rhino-conjunctivitis, Allergic asthma
- Medical subject headings
- Hypersensitivity, Immediate, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeDALL questionnaire for allergic diseasesDiagnostic test
Also called Mechanisms of the development of allergy
Questionnaire about allergic symptoms and disease
Registration of allergic symptomsDiagnostic test
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.
Skin Prick TestDiagnostic test
Diagnostic skin test for sensitization to allergens
Specific IgE in serumDiagnostic test
Also called IgE
Diagnostic test for sensitization to allergens in serum
Nasal provocation testDiagnostic test
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 Activation TestDiagnostic test
Also called BAT
Basophil leukocytes are extracted from full blood and exposed to 6 different doses of allergen and activation of basophils are measured.
| Study group | Role | What they receive |
|---|---|---|
| Patients | 30 patients with self-reported seasonal allergic airway symptoms in the period from 1st of August to 15.th of october Receives: 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 | |
| Controls | 15 non-allergic individuals Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergy to Birch rust fungi
Allergic symptoms during spread of Birch rust spores and positive sensitization and nasal provocation test to birch rust fungi.
Measured: 1st of August to 15th of October 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Aug 2020
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity, ImmediateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Luxembourg Institute of Health, Oslo University Hospital
- Responsible party
- Principal investigator, Martin Sørensen, University Hospital of North Norway
- Investigators
- Martin Sørensen, PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322838
- Sponsor's protocol ID
- 62924 (REK)
- Acronym
- Tro-BRA
- Status last verified
- Apr 2021
- First submitted
- 24 Mar 2020
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Cadham,F.T., Asthma due to grain rusts. Jama, 1924, 83(1):p.27.
Waldbott, G.L.A., M.S., Rust and Smut, Major causes of respiratory allergy. Ann Intern Med., 1940. 14(2):p.215-224
Croce MA, da Costa Manso ER, Gambale W, Takayama L, Oliveira Andrade CE, Pereira Pinto JH, Morato Castro FF, Croce J. Sensitization to the fungus Hemileia vastatrix (coffee leaf rust). Allergy. 2001 Jul;56(7):684-7. doi: 10.1034/j.1398-9995.2001.00053.x.
PubMed 11421929Simon-Nobbe B, Denk U, Poll V, Rid R, Breitenbach M. The spectrum of fungal allergy. Int Arch Allergy Immunol. 2008;145(1):58-86. doi: 10.1159/000107578. Epub 2007 Aug 20.
PubMed 17709917Horner WE, Lopez M, Salvaggio JE, Lehrer SB. Basidiomycete allergy: identification and characterization of an important allergen from Calvatia cyathiformis. Int Arch Allergy Appl Immunol. 1991;94(1-4):359-61. doi: 10.1159/000235403.
PubMed 1937899Gupta, D.A., Environmental and occupational respiratory diseases - 1033. Rust fungi of plants and high IgE levels in asymptomatic workers of a stored food grains godown: a possible relationship. World Allergy Organization Journal, 2013. 6(suppl 1):p.32.
Hohmann C, Pinart M, Tischer C, Gehring U, Heinrich J, Kull I, Melen E, Smit HA, Torrent M, Wijga AH, Wickman M, Bachert C, Lodrup Carlsen KC, Carlsen KH, Bindslev-Jensen C, Eller E, Esplugues A, Fantini MP, Annesi-Maesano I, Momas I, Porta D, Vassilaki M, Waiblinger D, Sunyer J, Anto JM, Bousquet J, Keil T; MeDALL Study Group. The development of the MeDALL Core Questionnaires for a harmonized follow-up assessment of eleven European birth cohorts on asthma and allergies. Int Arch Allergy Immunol. 2014;163(3):215-24. doi: 10.1159/000357732. Epub 2014 Mar 1.
PubMed 24642608Bousquet J, Devillier P, Anto JM, Bewick M, Haahtela T, Arnavielhe S, Bedbrook A, Murray R, van Eerd M, Fonseca JA, Morais Almeida M, Todo Bom A, Menditto E, Passalacqua G, Stellato C, Triggiani M, Ventura MT, Vezzani G, Annesi-Maesano I, Bourret R, Bosse I, Caimmi D, Cartier C, Demoly P, Just J, Portejoie F, Siroux V, Viart F, Bergmann KC, Keil T, Klimek L, Mosges R, Pfaar O, Shamai S, Zuberbier T, Mullol J, Valero A, Spranger O, Tomazic PV, Kowalski ML, Kuna P, Kupczyk M, Raciborski F, Samolinski B, Toppila-Salmi SK, Valovirta E, Cruz AA, Sarquis-Serpa F, da Silva J, Stelmach R, Larenas-Linnemann D, Rodriguez Gonzalez M, Burguete Cabanas MT, Kvedariene V, Valiulis A, Chavannes NH, Fokkens WJ, Ryan D, Sheikh A, Bachert C, Hellings PW, VandenPlas O, Ballardini N, Kull I, Melen E, Westman M, Wickman M, Bindslev-Jensen C, Eller E, Bosnic-Anticevich S, O'Hehir RE, Agache I, Bieber T, Casale T, Gemicioglu B, Ivancevich JC, De Vries G, Sorensen M, Yorgancioglu A, Laune D; MACVIA working group. Daily allergic multimorbidity in rhinitis using mobile technology: A novel concept of the MASK study. Allergy. 2018 Aug;73(8):1622-1631. doi: 10.1111/all.13448. Epub 2018 Apr 24.
PubMed 29569295Sorensen M, Kuehn A, Mills ENC, Costello CA, Ollert M, Smabrekke L, Primicerio R, Wickman M, Klingenberg C. Cross-reactivity in fish allergy: A double-blind, placebo-controlled food-challenge trial. J Allergy Clin Immunol. 2017 Oct;140(4):1170-1172. doi: 10.1016/j.jaci.2017.03.043. Epub 2017 May 4. No abstract available.
PubMed 28479332Schiener M, Hilger C, Eberlein B, Pascal M, Kuehn A, Revets D, Planchon S, Pietsch G, Serrano P, Moreno-Aguilar C, de la Roca F, Biedermann T, Darsow U, Schmidt-Weber CB, Ollert M, Blank S. The high molecular weight dipeptidyl peptidase IV Pol d 3 is a major allergen of Polistes dominula venom. Sci Rep. 2018 Jan 22;8(1):1318. doi: 10.1038/s41598-018-19666-7.
PubMed 29358620Kuehn A, Codreanu-Morel F, Lehners-Weber C, Doyen V, Gomez-Andre SA, Bienvenu F, Fischer J, Ballardini N, van Hage M, Perotin JM, Silcret-Grieu S, Chabane H, Hentges F, Ollert M, Hilger C, Morisset M. Cross-reactivity to fish and chicken meat - a new clinical syndrome. Allergy. 2016 Dec;71(12):1772-1781. doi: 10.1111/all.12968. Epub 2016 Jul 15.
PubMed 27344988Kuehn A, Hilger C, Lehners-Weber C, Codreanu-Morel F, Morisset M, Metz-Favre C, Pauli G, de Blay F, Revets D, Muller CP, Vogel L, Vieths S, Hentges F. Identification of enolases and aldolases as important fish allergens in cod, salmon and tuna: component resolved diagnosis using parvalbumin and the new allergens. Clin Exp Allergy. 2013 Jul;43(7):811-22. doi: 10.1111/cea.12117.
PubMed 23786287Dahlen B, Nopp A, Johansson SG, Eduards M, Skedinger M, Adedoyin J. Basophil allergen threshold sensitivity, CD-sens, is a measure of allergen sensitivity in asthma. Clin Exp Allergy. 2011 Aug;41(8):1091-7. doi: 10.1111/j.1365-2222.2011.03763.x. Epub 2011 Apr 25.
PubMed 21518044Hoffmann HJ, Santos AF, Mayorga C, Nopp A, Eberlein B, Ferrer M, Rouzaire P, Ebo DG, Sabato V, Sanz ML, Pecaric-Petkovic T, Patil SU, Hausmann OV, Shreffler WG, Korosec P, Knol EF. The clinical utility of basophil activation testing in diagnosis and monitoring of allergic disease. Allergy. 2015 Nov;70(11):1393-405. doi: 10.1111/all.12698. Epub 2015 Sep 8.
PubMed 26198455
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04322838
- Acronym / sponsor ID
- Tro-BRA / 62924 (REK)
- Conditions
- Hypersensitivity, Immediate, Allergy
- Keywords
- Birch rust fungi, Melampsoridium Betulinum, Allergy, Allergic rhino-conjunctivitis, Allergic asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Luxembourg Institute of Health, Oslo University Hospital
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | 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 Test30 patients with self-reported seasonal allergic airway symptoms in the period from 1st of August to 15.th of october |
| Controls | – | 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 Test15 non-allergic individuals |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with allergic symptoms of allergic rhino-conjunctivitis and/or allergic asthma in the period from 1st of august to 15th of October.
Key inclusion criteria (1 listed)
- Self reported seasonal airway allergic symptoms during autumn
Key exclusion criteria (1 listed)
- Perennial airway allergic symptoms without worsening during autumn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeDALL questionnaire for allergic diseasesAlso: Mechanisms of the development of allergyQuestionnaire about allergic symptoms and disease | Diagnostic test | Controls, Patients |
| Registration of allergic symptomsDaily 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 test | Controls, Patients |
| Skin Prick TestDiagnostic skin test for sensitization to allergens | Diagnostic test | Controls, Patients |
| Specific IgE in serumAlso: IgEDiagnostic test for sensitization to allergens in serum | Diagnostic test | Controls, Patients |
| Nasal provocation testDiagnostic 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) | Diagnostic test | Controls, Patients |
| Basophil Activation TestAlso: BATBasophil leukocytes are extracted from full blood and exposed to 6 different doses of allergen and activation of basophils are measured. | Diagnostic test | Controls, Patients |
Primary outcome
Allergy to Birch rust fungi
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- BackgroundCadham,F.T., Asthma due to grain rusts. Jama, 1924, 83(1):p.27.
- BackgroundWaldbott, G.L.A., M.S., Rust and Smut, Major causes of respiratory allergy. Ann Intern Med., 1940. 14(2):p.215-224
- Background: PubMed 11421929Croce MA, da Costa Manso ER, Gambale W, Takayama L, Oliveira Andrade CE, Pereira Pinto JH, Morato Castro FF, Croce J. Sensitization to the fungus Hemileia vastatrix (coffee leaf rust). Allergy. 2001 Jul;56(7):684-7. doi: 10.1034/j.1398-9995.2001.00053.x.
- Background: PubMed 17709917Simon-Nobbe B, Denk U, Poll V, Rid R, Breitenbach M. The spectrum of fungal allergy. Int Arch Allergy Immunol. 2008;145(1):58-86. doi: 10.1159/000107578. Epub 2007 Aug 20.
- Background: PubMed 1937899Horner WE, Lopez M, Salvaggio JE, Lehrer SB. Basidiomycete allergy: identification and characterization of an important allergen from Calvatia cyathiformis. Int Arch Allergy Appl Immunol. 1991;94(1-4):359-61. doi: 10.1159/000235403.
- BackgroundGupta, D.A., Environmental and occupational respiratory diseases - 1033. Rust fungi of plants and high IgE levels in asymptomatic workers of a stored food grains godown: a possible relationship. World Allergy Organization Journal, 2013. 6(suppl 1):p.32.
- Background: PubMed 24642608Hohmann C, Pinart M, Tischer C, Gehring U, Heinrich J, Kull I, Melen E, Smit HA, Torrent M, Wijga AH, Wickman M, Bachert C, Lodrup Carlsen KC, Carlsen KH, Bindslev-Jensen C, Eller E, Esplugues A, Fantini MP, Annesi-Maesano I, Momas I, Porta D, Vassilaki M, Waiblinger D, Sunyer J, Anto JM, Bousquet J, Keil T; MeDALL Study Group. The development of the MeDALL Core Questionnaires for a harmonized follow-up assessment of eleven European birth cohorts on asthma and allergies. Int Arch Allergy Immunol. 2014;163(3):215-24. doi: 10.1159/000357732. Epub 2014 Mar 1.
- Background: PubMed 29569295Bousquet J, Devillier P, Anto JM, Bewick M, Haahtela T, Arnavielhe S, Bedbrook A, Murray R, van Eerd M, Fonseca JA, Morais Almeida M, Todo Bom A, Menditto E, Passalacqua G, Stellato C, Triggiani M, Ventura MT, Vezzani G, Annesi-Maesano I, Bourret R, Bosse I, Caimmi D, Cartier C, Demoly P, Just J, Portejoie F, Siroux V, Viart F, Bergmann KC, Keil T, Klimek L, Mosges R, Pfaar O, Shamai S, Zuberbier T, Mullol J, Valero A, Spranger O, Tomazic PV, Kowalski ML, Kuna P, Kupczyk M, Raciborski F, Samolinski B, Toppila-Salmi SK, Valovirta E, Cruz AA, Sarquis-Serpa F, da Silva J, Stelmach R, Larenas-Linnemann D, Rodriguez Gonzalez M, Burguete Cabanas MT, Kvedariene V, Valiulis A, Chavannes NH, Fokkens WJ, Ryan D, Sheikh A, Bachert C, Hellings PW, VandenPlas O, Ballardini N, Kull I, Melen E, Westman M, Wickman M, Bindslev-Jensen C, Eller E, Bosnic-Anticevich S, O'Hehir RE, Agache I, Bieber T, Casale T, Gemicioglu B, Ivancevich JC, De Vries G, Sorensen M, Yorgancioglu A, Laune D; MACVIA working group. Daily allergic multimorbidity in rhinitis using mobile technology: A novel concept of the MASK study. Allergy. 2018 Aug;73(8):1622-1631. doi: 10.1111/all.13448. Epub 2018 Apr 24.
- Background: PubMed 28479332Sorensen M, Kuehn A, Mills ENC, Costello CA, Ollert M, Smabrekke L, Primicerio R, Wickman M, Klingenberg C. Cross-reactivity in fish allergy: A double-blind, placebo-controlled food-challenge trial. J Allergy Clin Immunol. 2017 Oct;140(4):1170-1172. doi: 10.1016/j.jaci.2017.03.043. Epub 2017 May 4. No abstract available.
- Background: PubMed 29358620Schiener M, Hilger C, Eberlein B, Pascal M, Kuehn A, Revets D, Planchon S, Pietsch G, Serrano P, Moreno-Aguilar C, de la Roca F, Biedermann T, Darsow U, Schmidt-Weber CB, Ollert M, Blank S. The high molecular weight dipeptidyl peptidase IV Pol d 3 is a major allergen of Polistes dominula venom. Sci Rep. 2018 Jan 22;8(1):1318. doi: 10.1038/s41598-018-19666-7.
- Background: PubMed 27344988Kuehn A, Codreanu-Morel F, Lehners-Weber C, Doyen V, Gomez-Andre SA, Bienvenu F, Fischer J, Ballardini N, van Hage M, Perotin JM, Silcret-Grieu S, Chabane H, Hentges F, Ollert M, Hilger C, Morisset M. Cross-reactivity to fish and chicken meat - a new clinical syndrome. Allergy. 2016 Dec;71(12):1772-1781. doi: 10.1111/all.12968. Epub 2016 Jul 15.
- Background: PubMed 23786287Kuehn A, Hilger C, Lehners-Weber C, Codreanu-Morel F, Morisset M, Metz-Favre C, Pauli G, de Blay F, Revets D, Muller CP, Vogel L, Vieths S, Hentges F. Identification of enolases and aldolases as important fish allergens in cod, salmon and tuna: component resolved diagnosis using parvalbumin and the new allergens. Clin Exp Allergy. 2013 Jul;43(7):811-22. doi: 10.1111/cea.12117.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Sørensen, PhD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity, Immediate and Allergy, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergy to Birch rust fungi (time frame: 1st of August to 15th of October 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04322838, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.