Effect of holoBLG on Cat Allergic Patients

Allergic Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455749
• Other study ID #: 039-P-21
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: March 16, 2022

Study information

• Verified date: July 2022
• Source: Allergy Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 16, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Allergy to Cats

Intervention

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)

Locations

Country	Name	City	State
Germany	ECARF Institute GmbH	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Allergy Therapeutics	Bencard Allergie GmbH, Ecarf Institute GmbH

Country where clinical trial is conducted

Germany, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	PNIF	PNIF (peak nasal inspiration flow) liter/minute.	Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
Secondary	PEF	PEF (peak expiratory flow) liter/minute	Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
Secondary	FEV1	Forced expiratory volume in 1 second, before and after the exposure	Recorded at time zero (0) and 120 minutes
Secondary	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
Secondary	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
Secondary	NPT	Changes in Nasal Provocation Test before and after intervention period	up to 3 months following first AEC
Secondary	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