Effect of holoBLG on Cat Allergic Patients

Not Applicable

Completed

• Conditions: Allergy to Cats; Allergic Rhinoconjunctivitis
• Interventions: Dietary Supplement: holoBLG

• Registration Number: NCT05455749
• Lead Sponsor: Allergy Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-04
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-16
• Status Verified: 2022-07
• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-13
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
holoBLG	holoBLG	-

Primary Outcome Measures

Name	Time	Method
TSS	After 120 minutes of allergen challenge	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.

Secondary Outcome Measures

Name	Time	Method
TBSS	Up to 120 minutes following allergen challenge	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.
FEV1/FVC	Recorded at time zero (0) and 120 minutes	Forced expiratory volume in 1 second/forced vital capacity ratio, before and after the exposure.
PNIF	Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes	PNIF (peak nasal inspiration flow) liter/minute.
FEV1	Recorded at time zero (0) and 120 minutes	Forced expiratory volume in 1 second, before and after the exposure
VAS	Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes	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".
PEF	Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes	PEF (peak expiratory flow) liter/minute
NPT	up to 3 months following first AEC	Changes in Nasal Provocation Test before and after intervention period
TNSS	Up to 120 minutes following allergen challenge	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.
TESS	Up to 120 minutes following allergen challenge	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.
Adverse events with regards to the allergen exposure	up to 24 hours after AEC exposure	Number of events and number of patients recording late-phase reactions and/or adverse events with regards to the allergen exposure
TOSS	Up to 120 minutes following allergen challenge	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.

Trial Locations

Locations (1)

ECARF Institute GmbH; 🇩🇪 Berlin, Germany