Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2021-10-04
2022-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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holoBLG
holoBLG
holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, loaded with ligands (vitamin A, zinc and polyphenol-iron complexes)
Interventions
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holoBLG
holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, loaded with ligands (vitamin A, zinc and polyphenol-iron complexes)
Eligibility Criteria
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Inclusion Criteria
* positive SPT (wheal \>3mm)
* Positive NPT
* Increase in TSS \>3 during the 1st exposure in the AEC
* Verbal and written consent
Exclusion Criteria
* subjects taking immunosuppressive drugs such as systemic corticosteroids, cyclosporine, etc.
* subjects who have received or are currently receiving sublingual or subcutaneous immunotherapy (SLIT/SCIT) for cat allergy in the last 2 years prior to V0
* clinically relevant overreactions to the ingredients of holoBLG, in particular subjects with a milk protein allergy or pronounced lactose intolerance
* subjects with severe asthma and/or a history of uncontrolled asthmatic attacks in the last three months before the selection process (GINA 4 and 5).
* subjects with an FEV1 \<70% (predicted value) prior to exposure in the AEC
* Lack of verbal and written informed consent
* subjects who are not proficient in the German language
* History of serious chronic medical illness and/or any condition for which the local investigator believes that participation in the study could pose a risk to the individual
* Pregnancy and lactation
* Contraindications and/or history of adrenaline intolerance and/or emergency medications
* Concurrent use of anti-allergic medications and/or inadequate washout period of these anti-allergic medications prior to the selection process and exposure in the exposure chamber
* TSS ≥ 6 at t0 of first exposure in the AEC
* Subjects who have a history of ingestion of holoBLG
18 Years
65 Years
ALL
No
Sponsors
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Ecarf Institute GmbH
OTHER
Bencard Allergie GmbH
OTHER
Allergy Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Karl-Christian Bergmann, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Institute of Allergology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Locations
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ECARF Institute GmbH
Berlin, , Germany
Countries
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References
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Bergmann KC, Raab J, Graessel A, Zwingers T, Becker S, Kugler S, Zuberbier T, Roth-Walter F, Kramer MF, Jensen-Jarolim E. The holo beta-lactoglobulin lozenge reduces symptoms in cat allergy-Evaluation in an allergen exposure chamber and by titrated nasal allergen challenge. Clin Transl Allergy. 2023 Jul;13(7):e12274. doi: 10.1002/clt2.12274.
Other Identifiers
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039-P-21
Identifier Type: -
Identifier Source: org_study_id