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 Type
OBSERVATIONAL
Enrollment
27
ECARF Institute GmbH
Berlin, Germany
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.
Time frame: After 120 minutes of allergen challenge
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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes
PNIF
PNIF (peak nasal inspiration flow) liter/minute.
Time frame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
PEF
PEF (peak expiratory flow) liter/minute.
Time frame: 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.
Time frame: 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.
Time frame: Recorded at time zero (0) and 120 minutes
rescue medication and/or emergency treatment
Need for rescue medication and/or emergency treatment
Time frame: 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.
Time frame: up to 24 hours after AEC exposure
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