Effect of holoBLG on Cat Allergic Patients (NCT05455749) | Clinical Trial Compass
CompletedNot Applicable
Effect of holoBLG on Cat Allergic Patients
Germany42 participantsStarted 2021-10-04
Plain-language summary
The aim of the study is to investigate the antigen-unspecific effect of a 3 months supplementation with a food for special medical purposes (FSMP) in form of a lozenge containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in patients with allergic rhinoconjunctivitis caused by cat (hair/dander) and the associated symptoms (symptom type and severity) during exposure to cat allergen in an Allergen Exposure Chamber (AEC).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 1 year of clinically relevant cat allergy
* positive SPT (wheal \>3mm)
* Positive NPT
* Increase in TSS \>3 during the 1st exposure in the AEC
* Verbal and written consent
Exclusion Criteria:
* subjects \<18 years
* 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 AE…
What they're measuring
1
TSS
Timeframe: After 120 minutes of allergen challenge