Effect of holoBLG on Cat Allergic Patients

NCT05455749 | Completed

• 1 other identifier: 039-P-21
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergy to Cats; Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• TSS

  Total Symptom Score in response to cat exposure in an AEC at baseline versus final AEC exposure. The TSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose), 4 eye symptoms (itchy eyes, watery eyes, gritty feeling, eye reddening), 4 bronchial symptoms (wheezing, cough, breathlessness, rhonchus), and 2 other symptoms (itchy palate, and itchy skin) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TSS of 42.

  After 120 minutes of allergen challenge

Secondary Outcomes (11)

• TNSS

  Up to 120 minutes following allergen challenge

• TESS

  Up to 120 minutes following allergen challenge

• TBSS

  Up to 120 minutes following allergen challenge

• VAS

  Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes

• PNIF

  Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes

Study Arms (1)

holoBLG

EXPERIMENTAL

Dietary Supplement: holoBLG

Interventions

holoBLG DIETARY_SUPPLEMENT

holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, loaded with ligands (vitamin A, zinc and polyphenol-iron complexes)

holoBLG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergy Therapeutics: lead
• Ecarf Institute GmbH: collaborator
• Bencard Allergie GmbH: collaborator

Study Sites (1)

ECARF Institute GmbH

Berlin, 10115, Germany

Location

Related Publications (1)

• 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.

  PMID: 37488734 RESULT

Study Officials

• Karl-Christian Bergmann, Prof. Dr. med.

  Institute of Allergology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: October 4, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 16, 2022
• Last Updated: December 18, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)