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| Name | Class |
|---|---|
| Bencard Allergie GmbH | OTHER |
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The aim of the study is to investigate the long-term effect of a lozenge containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in people with allergic rhinoconjunctivitis caused by house dust mites and the associated symptoms (symptom type and severity) during exposure to house dust mites in an Allergen Exposure Chamber (AEC).
In particular, the study aims to evaluate whether the improvements in symptoms of house dust mite-induced rhinoconjunctivitis observed after 3 months of supplementation with holo-BLG can still be detected 7 to 8 months after the last intake.
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| Measure | Description | Time Frame |
|---|---|---|
| TNSS | Total Nasal Symptom Score (TNSS) in response to HDM exposure in an AEC at V1 (baseline AEC exposure) versus V5 (follow-up AEC exposure). The 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. | After 120 minutes of allergen challenge |
| Measure | Description | Time Frame |
|---|---|---|
| TSS | Total Symptom Score in response to HDM exposure in an AEC at V1 (baseline AEC exposure) versus V5 (follow-up AEC exposure). The TSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose), 3 eye symptoms (itchy eyes, watery eyes, and gritty feeling), 4 bronchial symptoms (wheezing, cough, breathlessness, and asthma), 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 39. |
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Inclusion Criteria:
Exclusion Criteria:
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study participants must have been participated in the in the predecessor study (supplementation phase with holo-BLG) including complete intake of the holo-BLG lozenge for 3 months and must have been included in the final analysis set of the predecessor study
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia Becker | Ecarf Institute GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECARF Institute GmbH | Berlin | 10115 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Bergmann, KC., Raab, J., Krause, L. et al. Long-term benefits of targeted micronutrition with the holoBLG lozenge in house dust mite allergic patients. Allergo J Int (2022). https://doi.org/10.1007/s40629-021-00197-z |
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| ID | Term |
|---|---|
| D000092542 | Dust Mite Allergy |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Up to 120 minutes following allergen challenge |
| TESS | The Total Eye Symptom Score (TESS) is the sum of 3 eye symptoms (itchy eyes, watery eyes, and gritty feeling) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TESS of 9. | Up to 120 minutes following allergen challenge |
| TBSS | The Total Bronchial Symptom Score (TBSS) is the sum of 4 bronchial symptoms (wheezing, cough, breathlessness, and asthma) 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 the 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 |
| rescue medication and/or emergency treatment | Need for rescue medication and/or emergency treatment | during and up to 24 hours after AEC exposure |
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |