Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species

NCT05101733 | Unknown

• 1 other identifier: 1318/2021
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Mold allergies are becoming increasingly important among the population. Increasing amounts of fungal spores are analyzed in air-samples because of urbanization, industrialization of food products and climate change. Mold also grows indoor and hence lead to additional health complaints. Alternaria alternata, and its only major allergen Alt a 1, is the most important fungus for allergy sufferers. Alternaria alternata can not only cause allergic symptoms but can also cause intensified asthmatic symptoms. Besides Alternaria alternata, there are over 700 other species of the genus Alternaria. The influence of these other species on allergic symptoms is poorly understood. Furthermore, prevalence and incidence of an allergy to Alternaria alternata among the Austrian population is not known. Estimates range between 1-5% among the Austrian population. This study aims to further investigate the incidence and characteristics of an allergy to Alternaria in Austria. This will be investigated with the help of participants (50 Alternaria allergy sufferers and 20 non allergic participants), spore counts in Austria and crowd-sourced symptom data.

Conditions

Fungal Allergy; Allergy

Keywords

Allergy; Fungal allergy; Alternaria alternata

Outcome Measures

Primary Outcomes (1)

• Prevalence, Immunoglobulin-E (IgE)-antibodies to selected Alternaria species

  Determine the prevalence of sensitization to multiple Alternaria species in the Austrian population

  12 months

Secondary Outcomes (1)

• Cytokine-profile (e.g. Interleukin-13, Interleukin-5, Interleukin-10, TNFalpha, IFNgamma) upon Alt a 1 incubation

  12 months

Study Arms (2)

Alternaria allergy sufferers

50 people suffering from an allergy to Alternaria. These participants receive a questionnaire, a Skin-Prick-Test, a blood draw and nasal provocation with collection of nasal secretion

Diagnostic Test: Nasal provocation; Diagnostic Test: Skin-Prick Test; Diagnostic Test: Blood draw; Diagnostic Test: Collection of nasal secretion

Non-allergic participants

Non allergic participants (20) receive a questionnaire, a blood draw and collection of nasal secretion

Diagnostic Test: Blood draw; Diagnostic Test: Collection of nasal secretion

Interventions

Nasal provocation DIAGNOSTIC_TEST

Nasal provocation with Alternaria alternata extract. Changes in nasal mucosa are measured with a rhinomanometry device

Alternaria allergy sufferers

Skin-Prick Test DIAGNOSTIC_TEST

Skin-Prick-Test is administered to determine an allergy against Alternaria

Alternaria allergy sufferers

Blood draw DIAGNOSTIC_TEST

For further analysis

Alternaria allergy sufferers; Non-allergic participants

Collection of nasal secretion DIAGNOSTIC_TEST

Allergy sufferers: After nasal provocation Non-allergics: After administration of isotonic nasal spray

Alternaria allergy sufferers; Non-allergic participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited with the help of advertisements on the social media pages of the Austrian Pollen Information Service and on the pollen diary app

You may qualify if:

• Participants will be healthy people over 18 years of age. Allergic participants should have an allergic reaction against Alternaria, visible in the Skin-Prick-Test. Furthermore symptom data in the pollen diary of the Austrian Pollen Information Service should be existing

You may not qualify if:

• Subjects participating in a pharmacological study, pregnant subjects and subjects with an existing infectious- and/or autoimmune disease

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Interventions

Nasal Provocation Tests; Patch Tests; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Investigative Techniques; Immunologic Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative

Study Officials

• Erika Jensen-Jarolim, Univ.-Prof. Dr.

  Department of Pathophysiology and Allergy Research

  STUDY DIRECTOR

Central Study Contacts

Markus Berger, Dr.

CONTACT

+4369918939871; markus.berger@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. univ.

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: November 1, 2021
• Study Start: October 14, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

AU (1)