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Clinical Trial Summary

A validated mobile Allergen exposure chamber (AEC) is used to expose qualified study participants suffering from house dust mite (HDM) induced allergic rhinoconjunctivitis. A maximum of four individuals are exposed at a time under standardized conditions with a mixture of allergens from Dermatophagoides pteronyssinus and Dermatophagoides farinae (each 50%, faeces and body allergens; doses of 250 μg/m3 air; 21°C, and 55% relative air moisture). After the first exposure, a dietary supplement lozenge, containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols, is taken twice daily for a period of 12 weeks, followed by the second exposure. A minimum of thirty persons are challenged with HDM allergen. After entering the chamber there is an acclimatization phase of 20 minutes with no exposure. Exposure time starts after acclimatization in the chamber and is 120 minutes at each visit. Objective parameters are recorded every 30 minutes, and subjective parameters are recorded every 10 minutes over a period of 120 minutes. During the exposure a plateau (steady-state) of total nasal symptom score with a difference from baseline is measured in all participants for each of the two exposures with HDM.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04477382
Study type Observational
Source Ecarf Institute GmbH
Contact
Status Completed
Phase
Start date January 6, 2020
Completion date June 30, 2020

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