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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study Regarding Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species

Conditions
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Allergy, Fungal Allergy

Intervention / Treatment
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* Diagnostic Test: Nasal provocation
* Diagnostic Test: Skin-Prick Test
* Diagnostic Test: Blood draw
* Diagnostic Test: Collection of nasal secretion


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Subjects participating in a pharmacological study, pregnant subjects and subjects with an existing infectious- and/or autoimmune disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alternaria allergy sufferers<br>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<br>* Nasal provocation with Alternaria alternata extract. Changes in nasal mucosa are measured with a rhinomanometry device<br>Diagnostic Test: Skin-Prick Test<br>* Skin-Prick-Test is administered to determine an allergy against Alternaria<br>Diagnostic Test: Blood draw<br>* For further analysis<br>Diagnostic Test: Collection of nasal secretion<br>* Allergy sufferers: After nasal provocation Non-allergics: After administration of isotonic nasal spray<br>|
| Non-allergic participants<br>Non allergic participants (20) receive a questionnaire, a blood draw and collection of nasal secretion | Diagnostic Test: Blood draw<br>* For further analysis<br>Diagnostic Test: Collection of nasal secretion<br>* Allergy sufferers: After nasal provocation Non-allergics: After administration of isotonic nasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine-profile (e.g. Interleukin-13, Interleukin-5, Interleukin-10, TNFalpha, IFNgamma) upon Alt a 1 incubation | 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) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergy, Fungal allergy, Alternaria alternata