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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, loaded with ligands (vitamin A, zinc and polyphenol-iron complexes)
ECARF Institute GmbH
Berlin, Germany
TSS
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.
Time frame: After 120 minutes of allergen challenge
TNSS
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.
Time frame: Up to 120 minutes following allergen challenge
TESS
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.
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, rhonchus) 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 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".
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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
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
NPT
Changes in Nasal Provocation Test before and after intervention period
Time frame: up to 3 months following first AEC
TOSS
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.
Time frame: Up to 120 minutes following allergen challenge