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

• Conditions: Fungal Allergy; Allergy
• Interventions: Diagnostic Test: Nasal provocation; Diagnostic Test: Collection of nasal secretion; Diagnostic Test: Skin-Prick Test; Diagnostic Test: Blood draw

• Registration Number: NCT05101733
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-30
• Study Start: 2021-10-14
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-11-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alternaria allergy sufferers	Blood draw	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
Non-allergic participants	Collection of nasal secretion	Non allergic participants (20) receive a questionnaire, a blood draw and collection of nasal secretion
Alternaria allergy sufferers	Skin-Prick Test	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
Alternaria allergy sufferers	Collection of nasal secretion	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
Alternaria allergy sufferers	Nasal provocation	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
Non-allergic participants	Blood draw	Non allergic participants (20) receive a questionnaire, a blood draw and collection of nasal secretion

Primary Outcome Measures

Name	Time	Method
Prevalence, Immunoglobulin-E (IgE)-antibodies to selected Alternaria species	12 months	Determine the prevalence of sensitization to multiple Alternaria species in the Austrian population

Secondary Outcome Measures

Name	Time	Method
Cytokine-profile (e.g. Interleukin-13, Interleukin-5, Interleukin-10, TNFalpha, IFNgamma) upon Alt a 1 incubation	12 months	Changes in the immun response when ligand-binding mononuclear cells from the blood to Alt a 1, characterized by the cytokine profile (Th1/Th2/regulatory) and the cell population (B- and T-cells, macrophages/monocytes)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria