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

NCT04322838 | Unknown

• 1 other identifier: 62924 (REK)
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypersensitivity, Immediate; Allergy

Keywords

Birch rust fungi; Melampsoridium Betulinum; Allergy; Allergic rhino-conjunctivitis; Allergic asthma

Outcome Measures

Primary Outcomes (1)

• Allergy to Birch rust fungi

  Allergic symptoms during spread of Birch rust spores and positive sensitization and nasal provocation test to birch rust fungi.

  1st of August to 15th of October 2020

Study Arms (2)

Patients

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

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

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

Interventions

MeDALL questionnaire for allergic diseases DIAGNOSTIC_TEST

Questionnaire about allergic symptoms and disease

Also known as: Mechanisms of the development of allergy

Controls; Patients

Registration of allergic symptoms 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.

Controls; Patients

Skin Prick Test DIAGNOSTIC_TEST

Diagnostic skin test for sensitization to allergens

Controls; Patients

Specific IgE in serum DIAGNOSTIC_TEST

Diagnostic test for sensitization to allergens in serum

Also known as: IgE

Controls; Patients

Nasal provocation test 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)

Controls; Patients

Basophil Activation Test DIAGNOSTIC_TEST

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

Also known as: BAT

Controls; Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Self reported seasonal airway allergic symptoms during autumn

You may not qualify if:

• Perennial airway allergic symptoms without worsening during autumn

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Luxembourg Institute of Health: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, Norway

RECRUITING

Related Publications (14)

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

  BACKGROUND

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

  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.

  PMID: 11421929 BACKGROUND

• 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.

  PMID: 17709917 BACKGROUND

• 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.

  PMID: 1937899 BACKGROUND

• 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.

  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.

  PMID: 24642608 BACKGROUND

• 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.

  PMID: 29569295 BACKGROUND

• 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.

  PMID: 28479332 BACKGROUND

• 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.

  PMID: 29358620 BACKGROUND

• 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.

  PMID: 27344988 BACKGROUND

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  PMID: 23786287 BACKGROUND

• 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.

  PMID: 21518044 BACKGROUND

• 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.

  PMID: 26198455 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum for measurement of specific IgE Full blood for Basophil Activation Test (BAT)

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Interventions

Patch Tests; Nasal Provocation Tests; Basophil Degranulation Test

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Diagnostic Techniques, Respiratory System

Study Officials

• Martin Sørensen, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Sørensen, PhD

CONTACT

+4790107879; martin.sorensen@unn.no

Elin Ørbeck Vallevik, MD

CONTACT

+4741645961; elin.orbeck.vallevik@unn.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department leader

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.

Locations

NO (1)