Fungal AllergyNCT05101733
Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species
An observational study of Fungal Allergy and Allergy, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fungal Allergy, Allergy
- What is being tested?
- Nasal provocation, Skin-Prick Test and Blood draw
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 14 Oct 2021to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- Subjects participating in a pharmacological study, pregnant subjects and subjects with an existing infectious- and/or autoimmune disease
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
About this study
Official title: Pilot Study Regarding Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species
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.
Read more
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
- Being tested
- Nasal provocation, Skin-Prick Test, Blood draw, Collection of nasal secretion
- Keywords
- Allergy, Fungal allergy, Alternaria alternata
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal provocationDiagnostic test
Nasal provocation with Alternaria alternata extract. Changes in nasal mucosa are measured with a rhinomanometry device
Skin-Prick TestDiagnostic test
Skin-Prick-Test is administered to determine an allergy against Alternaria
Blood drawDiagnostic test
For further analysis
Collection of nasal secretionDiagnostic test
Allergy sufferers: After nasal provocation Non-allergics: After administration of isotonic nasal spray
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Blood draw; Diagnostic Test: Collection of nasal secretion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence, Immunoglobulin-E (IgE)-antibodies to selected Alternaria species
Determine the prevalence of sensitization to multiple Alternaria species in the Austrian population
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start14 Oct 2021
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal AllergyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Markus Berger, Medical University of Vienna
- Investigators
- Erika Jensen-Jarolim, Univ.-Prof. Dr., Study director, Department of Pathophysiology and Allergy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101733
- Sponsor's protocol ID
- 1318/2021
- Status last verified
- Apr 2022
- First submitted
- 30 Sep 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Regarding Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species
- ClinicalTrials.gov ID
- NCT05101733
- Acronym / sponsor ID
- 1318/2021
- Conditions
- Fungal Allergy, Allergy
- Keywords
- Allergy, Fungal allergy, Alternaria alternata
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternaria allergy sufferers | – | Diagnostic Test: Nasal provocation, Diagnostic Test: Skin-Prick Test, Diagnostic Test: Blood draw, Diagnostic Test: Collection of nasal secretion50 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 | – | Diagnostic Test: Blood draw, Diagnostic Test: Collection of nasal secretionNon allergic participants (20) receive a questionnaire, a blood draw and collection of nasal secretion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects participating in a pharmacological study, pregnant subjects and subjects with an existing infectious- and/or autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal provocationNasal provocation with Alternaria alternata extract. Changes in nasal mucosa are measured with a rhinomanometry device | Diagnostic test | Alternaria allergy sufferers |
| Skin-Prick TestSkin-Prick-Test is administered to determine an allergy against Alternaria | Diagnostic test | Alternaria allergy sufferers |
| Blood drawFor further analysis | Diagnostic test | Alternaria allergy sufferers, Non-allergic participants |
| Collection of nasal secretionAllergy sufferers: After nasal provocation Non-allergics: After administration of isotonic nasal spray | Diagnostic test | Alternaria allergy sufferers, Non-allergic participants |
Primary outcome
Prevalence, Immunoglobulin-E (IgE)-antibodies to selected Alternaria species
Time frame: 12 months
Determine the prevalence of sensitization to multiple Alternaria species in the Austrian population
1 secondary outcome
Cytokine-profile (e.g. Interleukin-13, Interleukin-5, Interleukin-10, TNFalpha, IFNgamma) upon Alt a 1 incubation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Jensen-Jarolim, Univ.-Prof. Dr. study director
Department of Pathophysiology and Allergy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal Allergy and Allergy, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Berger, Dr. (+4369918939871, markus.berger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence, Immunoglobulin-E (IgE)-antibodies to selected Alternaria species (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.