Effect of holoBLG on Cat Allergic Patients

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

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).

Study Overview

• Status: Completed
• Conditions: Allergic Rhinoconjunctivitis; Allergy to Cats
• Intervention / Treatment: Dietary supplement: holoBLG

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10115
    • ECARF Institute GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: holoBLG	Dietary supplement: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNSS	The Total Nasal Symptom Score (TNSS) is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TNSS of 12.	Up to 120 minutes following allergen challenge
TESS	The Total Eye Symptom Score (TESS) is the sum of 4 eye symptoms (itchy eyes, watery eyes, gritty feeling, eye reddening) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TESS of 12.	Up to 120 minutes following allergen challenge
TBSS	The Total Bronchial Symptom Score (TBSS) is the sum of 4 bronchial symptoms (wheezing, cough, breathlessness, rhonchus) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TBSS of 12.	Up to 120 minutes following allergen challenge
VAS	Visual Analogue Scale: Before, every 30 minutes during and after each exposure patients grade the question on their well-being by putting a vertical line on a 10 cm line representing severity from 0 cm "very good" to 10 cm "very bad".	Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes
PNIF	PNIF (peak nasal inspiration flow) liter/minute.	Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
PEF	PEF (peak expiratory flow) liter/minute	Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
FEV1	Forced expiratory volume in 1 second, before and after the exposure	Recorded at time zero (0) and 120 minutes
FEV1/FVC	Forced expiratory volume in 1 second/forced vital capacity ratio, before and after the exposure.	Recorded at time zero (0) and 120 minutes
Adverse events with regards to the allergen exposure	Number of events and number of patients recording late-phase reactions and/or adverse events with regards to the allergen exposure	up to 24 hours after AEC exposure
NPT	Changes in Nasal Provocation Test before and after intervention period	up to 3 months following first AEC
TOSS	The Total Other Symptom Score (TBSS) is the sum of 2 additional symptoms (itchy palate, itchy skin) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TOSS of 6.	Up to 120 minutes following allergen challenge

Collaborators and Investigators

• Sponsor: Allergy Therapeutics
• Collaborators: Ecarf Institute GmbH; Bencard Allergie GmbH
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 039-P-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No