Clinical trial NCT05455749: Effect of holoBLG on Cat Allergic Patients
Official title: A Prospective Pilot Study to Observe the Effects of Cat Exposure in an Allergen Exposure Chamber (AEC) in Cat Allergic Patients Taking a Food for Special Medical Purposes (holoBLG) for 3 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy to Cats
Allergic Rhinoconjunctivitis
Lead sponsor: Allergy Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Ecarf Institute GmbH
name: Bencard Allergie GmbH
First posted: 2022-07-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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 AEC
* Subjects who have a history of ingestion of holoBLG

Primary outcomes:
measure: TSS
timeFrame: After 120 minutes of allergen challenge
Secondary outcomes:
measure: TNSS
timeFrame: Up to 120 minutes following allergen challenge
measure: TESS
timeFrame: Up to 120 minutes following allergen challenge
measure: TBSS
timeFrame: Up to 120 minutes following allergen challenge
measure: VAS
timeFrame: Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes
measure: PNIF
timeFrame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
measure: PEF
timeFrame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
measure: FEV1
timeFrame: Recorded at time zero (0) and 120 minutes
measure: FEV1/FVC
timeFrame: Recorded at time zero (0) and 120 minutes
measure: Adverse events with regards to the allergen exposure
timeFrame: up to 24 hours after AEC exposure
measure: NPT
timeFrame: up to 3 months following first AEC
measure: TOSS
timeFrame: Up to 120 minutes following allergen challenge
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: ECARF Institute GmbH
Study officials:
affiliation: Institute of Allergology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
name: Karl-Christian Bergmann, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.