Tromsø Birch Rust Allergy Study. Allergy to Birch Rust, a Possible Explanation to Seasonal Airway Allergy During Autumn?

NCT ID: NCT04322838

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypersensitivity, Immediate Allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

30 patients with self-reported seasonal allergic airway symptoms in the period from 1st of August to 15.th of october

MeDALL questionnaire for allergic diseases

Intervention Type DIAGNOSTIC_TEST

Questionnaire about allergic symptoms and disease

Registration of allergic symptoms

Intervention Type DIAGNOSTIC_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 Test

Intervention Type DIAGNOSTIC_TEST

Diagnostic skin test for sensitization to allergens

Specific IgE in serum

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for sensitization to allergens in serum

Nasal provocation test

Intervention Type DIAGNOSTIC_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 Test

Intervention Type DIAGNOSTIC_TEST

Basophil leukocytes are extracted from full blood and exposed to 6 different doses of allergen and activation of basophils are measured.

Controls

15 non-allergic individuals

MeDALL questionnaire for allergic diseases

Intervention Type DIAGNOSTIC_TEST

Questionnaire about allergic symptoms and disease

Registration of allergic symptoms

Intervention Type DIAGNOSTIC_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 Test

Intervention Type DIAGNOSTIC_TEST

Diagnostic skin test for sensitization to allergens

Specific IgE in serum

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for sensitization to allergens in serum

Nasal provocation test

Intervention Type DIAGNOSTIC_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 Test

Intervention Type DIAGNOSTIC_TEST

Basophil leukocytes are extracted from full blood and exposed to 6 different doses of allergen and activation of basophils are measured.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MeDALL questionnaire for allergic diseases

Questionnaire about allergic symptoms and disease

Intervention Type DIAGNOSTIC_TEST

Registration of allergic symptoms

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.

Intervention Type DIAGNOSTIC_TEST

Skin Prick Test

Diagnostic skin test for sensitization to allergens

Intervention Type DIAGNOSTIC_TEST

Specific IgE in serum

Diagnostic test for sensitization to allergens in serum

Intervention Type DIAGNOSTIC_TEST

Nasal provocation 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)

Intervention Type DIAGNOSTIC_TEST

Basophil Activation Test

Basophil leukocytes are extracted from full blood and exposed to 6 different doses of allergen and activation of basophils are measured.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mechanisms of the development of allergy IgE BAT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Self reported seasonal airway allergic symptoms during autumn

Exclusion Criteria

* Perennial airway allergic symptoms without worsening during autumn
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Luxembourg Institute of Health

OTHER_GOV

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Martin Sørensen

Department leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Sørensen, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of North Norway

Tromsø, , Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Martin Sørensen, PhD

Role: CONTACT

+4790107879

Elin Ørbeck Vallevik, MD

Role: CONTACT

+4741645961

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Martin Sørensen, cand med

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Cadham,F.T., Asthma due to grain rusts. Jama, 1924, 83(1):p.27.

Reference Type BACKGROUND

Waldbott, G.L.A., M.S., Rust and Smut, Major causes of respiratory allergy. Ann Intern Med., 1940. 14(2):p.215-224

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11421929 (View on PubMed)

Simon-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.

Reference Type BACKGROUND
PMID: 17709917 (View on PubMed)

Horner 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.

Reference Type BACKGROUND
PMID: 1937899 (View on PubMed)

Gupta, 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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 24642608 (View on PubMed)

Bousquet 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.

Reference Type BACKGROUND
PMID: 29569295 (View on PubMed)

Sorensen 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.

Reference Type BACKGROUND
PMID: 28479332 (View on PubMed)

Schiener 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.

Reference Type BACKGROUND
PMID: 29358620 (View on PubMed)

Kuehn 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.

Reference Type BACKGROUND
PMID: 27344988 (View on PubMed)

Kuehn 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.

Reference Type BACKGROUND
PMID: 23786287 (View on PubMed)

Dahlen 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.

Reference Type BACKGROUND
PMID: 21518044 (View on PubMed)

Hoffmann 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.

Reference Type BACKGROUND
PMID: 26198455 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

62924 (REK)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tolerability of ALK Tree Tablet
NCT00535639 COMPLETED PHASE1
House Dust Mite SLIT in Elderly Patients
NCT01605760 COMPLETED PHASE4