Hypersensitivity, ImmediateNor-BRANCT05661812
Norwegian Birch Rust Allergy Study
An observational study of Hypersensitivity, Immediate, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity, Immediate
- What is being tested?
- Quationnaires and symptom registration, PNIF and spirometry and SPT, spesific IgE, pBAT and NPT
- How many people
- 287 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2022to 31 May 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with allergic symptoms of rhino-conjunctivitis and/or asthma and/or eczema in the period from August 1 to October 15.
Who may be able to join
- Self-reported symptoms of allergic rhinitis, conjunctivitis, allergic asthma and/or exacerbation of eczema in the period from August to October.
Who cannot join
- Perennial airway allergy without worsening of symptoms during autumn.
- Too long or inadequate distance from home to hospital/testcenter.
- More than 14 days of absence from Northern Norway during symptomregistration autumn 2022 (August 15 - September 30, 2022).
- Diseases with persistent manifestations that can interfere or be confused with airway allergic symptoms.
- Treatment with immunosuppressive drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norwegian Birch Rust Allergy Study. Allergy to Birch Rust Fungi, a Possible Explanation to Seasonal Airway Allergy During Autumn?
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)
Read the 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 and/or asthma, and some also tells about worsening in eczema/skin 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.
- Conditions
- Hypersensitivity, Immediate
- Being tested
- Quationnaires and symptom registration, PNIF and spirometry, SPT, spesific IgE, pBAT and NPT
- Keywords
- Birch rust fungi, Melampsoridium Betulinum, Allergy, Allergic rhino-conjunctivitis, Allergic asthma, Eczema
- Medical subject headings
- Hypersensitivity, Immediate, Hypersensitivity, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quationnaires and symptom registrationDiagnostic test
Used to collect data about symptoms potentially characterising the allergy of MB. A shortened version of the MeDALL questionnaire (mechanisms of the development of allergic diseases) will be used to collect data about allergic diseases and symptoms. POEM questionnaire (Patient-Oriented Eczema Measure) will be used to evaluate atopic eczema once in the season of MB and once outside MB and pollen seasons. The participant will also register symptoms during two periods, preferably 6 weeks during MB season autumn (August-September) 2022 and 2 weeks outside MB and pollen seasons in January/February 2023. During the 8 weeks of symptom registration the participants will receive an e-mail every other day with questions regarding symptoms and medication.
PNIF and spirometryDiagnostic test
To clarify and verify the symptoms registered by the participants we will perform measurements of Peak Nasal Inspiratory Flow (PNIF) and spirometry. PNIF and spirometry will be used to assess airway obstruction through the nose and lungs, and will be performed in and outside the seasons of MB and pollen. Spirometry will be performed pre and post inhalation of bronchodilating medicine (reversibility test). Some of the participants (patients and controls) will be randomised to nasal provocation test (NPT), performed outside the seasons of MB and pollen, and for those PNIF and spirometry will be carried out before and after NPT.
SPT, spesific IgE, pBAT and NPTDiagnostic test
To evaluate the symptoms as specific for allergy the participants will be tested with skin prick test (SPT) with MB and common airway allergens, serum specific IgE (sIgE) to MB and common airway allergens, nasal provocation test (NPT) with MB and passive basophil activation test (pBAT) with MB. Blood samples for the sIgE and pBAT will be performed in MD season, while SPT and NPT will be performed outside seasons of MB and pollen. We will compare the results from SPT, sIgE and pBAT with the results from NPT to calculate sensitivity and specificity of SPT, sIgE and pBAT. All those tests demand that we are able to develop MB extracts that are suitable for those tests.
| Study group | Role | What they receive |
|---|---|---|
| Patients | 173 patients aged 18-75 years with self-reported allergic airways symptoms during autumn, primarily in August and September. Receives: Diagnostic Test: Quationnaires and symptom registration; Diagnostic Test: PNIF and spirometry; Diagnostic Test: SPT, spesific IgE, pBAT and NPT | |
| Controls | 114 controls aged 18-75, healthy, non-allergic individuals. Receives: Diagnostic Test: Quationnaires and symptom registration; Diagnostic Test: PNIF and spirometry; Diagnostic Test: SPT, spesific IgE, pBAT and NPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergy to birch rust fungi
Seasonal airway allergic symptoms during spread and exposure of Birch rust fungi in the autumn. Symptoms evaluated by questionnaire (VAS-scale) and exposure of birch rust measured as number of spores/cbm air
Measured: 15 th of August 2022 to 1 st of April 2023.
Allergy to birch rust fungi
Clarify and verify reported symptoms by measurements of PNIF (L/min) and spirometry (FEV1 and FVC in L and PEF in L/min)
Measured: 15 th of August 2022 to 1 st of April 2023.
Allergy to birch rust fungi
Evaluate positive sensitization to birch rust by the use of skin prick test, measurement of spesific IgE in blood, passive basofil activation test and nasal provocation test.
Measured: 15 th of August 2022 to 1 st of April 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Jan 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Retrospective
- Enrolment
- 287 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
- Sponsor
- Investigators
- Martin Sørensen, PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661812
- Sponsor's protocol ID
- 272466 (REK)
- Acronym
- Nor-BRA
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 14 May 2024
- 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
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 1937899Das, S. and D. Gupta, 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 Organ J, 2013. 6(Suppl 1): p. P32.
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 24642608Olsen RF, Svendsen K, Graf T, Kuehn A, Stubnova V, Sorensen M. Birch Rust Spore Exposure and Upper Airway Symptom Dynamics in a Subarctic Region: Indications for a Novel Seasonal Allergen. Clin Transl Allergy. 2026 Aug;16(8):e70196. doi: 10.1002/clt2.70196.
PubMed 42572169
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Birch Rust Allergy Study. Allergy to Birch Rust Fungi, a Possible Explanation to Seasonal Airway Allergy During Autumn?
- ClinicalTrials.gov ID
- NCT05661812
- Acronym / sponsor ID
- Nor-BRA / 272466 (REK)
- Conditions
- Hypersensitivity, Immediate
- Keywords
- Birch rust fungi, Melampsoridium Betulinum, Allergy, Allergic rhino-conjunctivitis, Allergic asthma, Eczema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Luxembourg Institute of Health, Oslo University Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 22 Dec 2022 (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.
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 and/or asthma, and some also tells about worsening in eczema/skin 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Quationnaires and symptom registration, Diagnostic Test: PNIF and spirometry, Diagnostic Test: SPT, spesific IgE, pBAT and NPT173 patients aged 18-75 years with self-reported allergic airways symptoms during autumn, primarily in August and September. |
| Controls | – | Diagnostic Test: Quationnaires and symptom registration, Diagnostic Test: PNIF and spirometry, Diagnostic Test: SPT, spesific IgE, pBAT and NPT114 controls aged 18-75, healthy, non-allergic individuals. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with allergic symptoms of rhino-conjunctivitis and/or asthma and/or eczema in the period from August 1 to October 15.
Key inclusion criteria (1 listed)
- Self-reported symptoms of allergic rhinitis, conjunctivitis, allergic asthma and/or exacerbation of eczema in the period from August to October.
Key exclusion criteria (5 listed)
- Perennial airway allergy without worsening of symptoms during autumn.
- Too long or inadequate distance from home to hospital/testcenter.
- More than 14 days of absence from Northern Norway during symptomregistration autumn 2022 (August 15 - September 30, 2022).
- Diseases with persistent manifestations that can interfere or be confused with airway allergic symptoms.
- Treatment with immunosuppressive drugs.
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 |
|---|---|---|
| Quationnaires and symptom registrationUsed to collect data about symptoms potentially characterising the allergy of MB. A shortened version of the MeDALL questionnaire (mechanisms of the development of allergic diseases) will be used to collect data about allergic diseases and symptoms. POEM questionnaire (Patient-Oriented Eczema Measure) will be used to evaluate atopic eczema once in the season of MB and once outside MB and pollen seasons. The participant will also register symptoms during two periods, preferably 6 weeks during MB season autumn (August-September) 2022 and 2 weeks outside MB and pollen seasons in January/February 2023. During the 8 weeks of symptom registration the participants will receive an e-mail every other day with questions regarding symptoms and medication. | Diagnostic test | Controls, Patients |
| PNIF and spirometryTo clarify and verify the symptoms registered by the participants we will perform measurements of Peak Nasal Inspiratory Flow (PNIF) and spirometry. PNIF and spirometry will be used to assess airway obstruction through the nose and lungs, and will be performed in and outside the seasons of MB and pollen. Spirometry will be performed pre and post inhalation of bronchodilating medicine (reversibility test). Some of the participants (patients and controls) will be randomised to nasal provocation test (NPT), performed outside the seasons of MB and pollen, and for those PNIF and spirometry will be carried out before and after NPT. | Diagnostic test | Controls, Patients |
| SPT, spesific IgE, pBAT and NPTTo evaluate the symptoms as specific for allergy the participants will be tested with skin prick test (SPT) with MB and common airway allergens, serum specific IgE (sIgE) to MB and common airway allergens, nasal provocation test (NPT) with MB and passive basophil activation test (pBAT) with MB. Blood samples for the sIgE and pBAT will be performed in MD season, while SPT and NPT will be performed outside seasons of MB and pollen. We will compare the results from SPT, sIgE and pBAT with the results from NPT to calculate sensitivity and specificity of SPT, sIgE and pBAT. All those tests demand that we are able to develop MB extracts that are suitable for those tests. | Diagnostic test | Controls, Patients |
Primary outcome
Allergy to birch rust fungi
Time frame: 15 th of August 2022 to 1 st of April 2023.
Seasonal airway allergic symptoms during spread and exposure of Birch rust fungi in the autumn. Symptoms evaluated by questionnaire (VAS-scale) and exposure of birch rust measured as number of spores/cbm air
Allergy to birch rust fungi
Time frame: 15 th of August 2022 to 1 st of April 2023.
Clarify and verify reported symptoms by measurements of PNIF (L/min) and spirometry (FEV1 and FVC in L and PEF in L/min)
Allergy to birch rust fungi
Time frame: 15 th of August 2022 to 1 st of April 2023.
Evaluate positive sensitization to birch rust by the use of skin prick test, measurement of spesific IgE in blood, passive basofil activation test and nasal provocation test.
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 14 May 2024.
- 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.
- BackgroundDas, S. and D. Gupta, 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 Organ J, 2013. 6(Suppl 1): p. P32.
- 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.
- Derived from this study: PubMed 42572169Olsen RF, Svendsen K, Graf T, Kuehn A, Stubnova V, Sorensen M. Birch Rust Spore Exposure and Upper Airway Symptom Dynamics in a Subarctic Region: Indications for a Novel Seasonal Allergen. Clin Transl Allergy. 2026 Aug;16(8):e70196. doi: 10.1002/clt2.70196.
- 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, 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 5 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 14 May 2024. 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: 15 th of August 2022 to 1 st of April 2023.). The study lists 3 primary outcomes in all. 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 NCT05661812, which also lists 6 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 14 May 2024.