Allergic Rhinitis, Dust Mite Allergy
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Bencard Allergie GmbH
Ecarf Institute GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participation in the predecessor study including complete intake of the holo-BLG lozenge for 3 months; inclusion in the final analysis set of the predecessor study * patients with allergic rhinoconjunctivitis caused by house dust mites of any gender, aged 18-65 years * Verbal and written informed consent
Exclusion criteria
* Persons \<18 years * lack of verbal and written consent * persons who do not speak German * seriously ill persons * Persons with immunosuppressive medication such as systemic corticosteroids, cyclosporine * Pregnancy and breastfeeding * psychiatric illness * Persons who have received or have started sublingual or subcutaneous immunotherapy (SLIT/SCIT) against house dust mites in the last 2 years before screening * Contraindications and/or history of adrenaline intolerance and/or emergency medication. * 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 * Use of an investigational drug 30 days/5 half-lives of the drug (whichever is longer) prior to screening * Use of certain drugs prior to V5: Systemic corticosteroids within 3 weeks; Topical nasal corticosteroids within 2 weeks; Chromones within 7 days; Antihistamines within 72h; Antibiotics within 3 months; Pro-, Pre- and Synbiotics 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TNSS | After 120 minutes of allergen challenge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TESS | Up to 120 minutes following allergen challenge | 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. |
| TBSS | Up to 120 minutes following allergen challenge | 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. |
| 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 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. |
| PNIF | Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes | PNIF (peak nasal inspiration flow) liter/minute. |
| TSS | Up to 120 minutes following allergen challenge | 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. |
| 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. |
| rescue medication and/or emergency treatment | during and up to 24 hours after AEC exposure | Need for rescue medication and/or emergency treatment |
| 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. |
| PEF | Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes | PEF (peak expiratory flow) liter/minute. |
Countries
Germany
Outcome results
None listed