ClinicalTrials.gg
Status unknownNCT05101733Updated Apr 12, 2022

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

An observational study in Fungal Allergy and Allergy, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by Medical University of Vienna · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fungal Allergy
  • Allergy

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Keywords

  • Allergy
  • Fungal allergy
  • Alternaria alternata
03

In context

Hypersensitivity

1,925 studies on the registry are indexed under Hypersensitivity; 261 are open to participants now.

This study's planned enrollment of 70 is below the median of 113 across 482 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Subjects participating in a pharmacological study, pregnant subjects and subjects with an existing infectious- and/or autoimmune disease
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testNasal provocation

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

  • Diagnostic testSkin-Prick Test

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

  • Diagnostic testBlood draw

    For further analysis

  • Diagnostic testCollection of nasal secretion

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

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  1. 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)

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Medical University of Vienna
    Vienna, 1090, Austria
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2021 (actual). Primary completion is estimated for Jul 2023, 21 months after the start.

Of 158 non-industry observational studies under Hypersensitivity, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 109. This study's planned 21 months is below that.

Counting every sponsor, half of 181 studies reached it within 30 months; a quarter within 13 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2021
First posted
Nov 1, 2021
StartActual
Oct 14, 2021
Primary completionEst.
Jul 2023
CompletionEst.
Jul 2023
Last update
Apr 12, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05101733
Responsible party
Dr. Markus Berger (Dr. med. univ., Medical University of Vienna) — Principal investigator
First posted
Nov 1, 2021
Start date
Oct 14, 2021
Primary completion
Jul 2023 (estimated)
Completion
Jul 2023 (estimated)
Last update
Apr 12, 2022

Study contacts

Markus Berger, Dr.
Contact
markus.berger@meduniwien.ac.at
+4369918939871
Erika Jensen-Jarolim, Univ.-Prof. Dr.
study director · Department of Pathophysiology and Allergy Research

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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