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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT05101733
Collaborator
(none)
70
1
20.5
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Nasal provocation
  • Diagnostic Test: Skin-Prick Test
  • Diagnostic Test: Blood draw
  • Diagnostic Test: Collection of nasal secretion

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Pilot Study Regarding Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species
Actual Study Start Date :
Oct 14, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

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

Diagnostic Test: Blood draw
For further analysis

Diagnostic Test: Collection of nasal secretion
Allergy sufferers: After nasal provocation Non-allergics: After administration of isotonic nasal spray

Non-allergic participants

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

Diagnostic Test: Blood draw
For further analysis

Diagnostic Test: Collection of nasal secretion
Allergy sufferers: After nasal provocation Non-allergics: After administration of isotonic nasal spray

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Study Director: Erika Jensen-Jarolim, Univ.-Prof. Dr., Department of Pathophysiology and Allergy Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Markus Berger, Dr. med. univ., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT05101733
Other Study ID Numbers:
  • 1318/2021
First Posted:
Nov 1, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Markus Berger, Dr. med. univ., Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022