Effect of holoBLG on Cat Allergic Patients

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Allergy to Cats, Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Dietary Supplement: holoBLG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: holoBLG<br> | Dietary Supplement: holoBLG<br>* holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, loaded with ligands (vitamin A, zinc and polyphenol-iron complexes)<br>|

What is the study measuring?
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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 |