Allergic Rhinoconjunctivitis, Allergy to Cats
Conditions
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).
Interventions
DIETARY_SUPPLEMENTholoBLG
holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, loaded with ligands (vitamin A, zinc and polyphenol-iron complexes)
Sponsors
Ecarf Institute GmbH
Bencard Allergie GmbH
Allergy Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| FEV1 | Recorded at time zero (0) and 120 minutes | Forced expiratory volume in 1 second, before and after the exposure |
Countries
Germany
Outcome results
None listed