Evaluation of the Long-term Effect of a 3-month Supplementation With Holo-BLG (Food for Special Medical Purposes) in People With Allergic Rhinoconjunctivitis Caused by House Dust Mites During Inhalation Exposure to Mite Allergen in an Exposure Chamber.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ecarf Institute GmbH
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- TNSS
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
TNSS
Time Frame: 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 Outcomes
- TBSS(Up to 120 minutes following allergen challenge)
- VAS(Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes)
- Adverse events with regards to the allergen exposure(up to 24 hours after AEC exposure)
- PEF(Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes)
- FEV1(Recorded at time zero (0) and 120 minutes)
- FEV1/FVC(Recorded at time zero (0) and 120 minutes)
- rescue medication and/or emergency treatment(during and up to 24 hours after AEC exposure)
- TESS(Up to 120 minutes following allergen challenge)
- PNIF(Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes)
- TSS(Up to 120 minutes following allergen challenge)