Effect of holoBLG on Cat Allergic Patients
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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".
- PNIF [Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes]
PNIF (peak nasal inspiration flow) liter/minute.
- PEF [Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes]
PEF (peak expiratory flow) liter/minute
- FEV1 [Recorded at time zero (0) and 120 minutes]
Forced expiratory volume in 1 second, before and after the exposure
- 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.
- 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
- NPT [up to 3 months following first AEC]
Changes in Nasal Provocation Test before and after intervention period
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ECARF Institute GmbH | Berlin | Germany | 10115 |
Sponsors and Collaborators
- Allergy Therapeutics
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 039-P-21