This clinical validation study is aimed at testing the efficacy of a new environmental challenge chamber (ECC) to induce symptoms of allergic rhinitis in patients allergic to house dust mite. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom Score (TNSS), allowing for determine whether the challenge is dose dependent and reproducible.
At Fraunhofer ITEM, a novel technique to create an atmosphere loaded with allergenic particles was recently developed. In brief, particles are produced in a combined process of nebulization and drying of a solution containing soluble allergenic extracts and lactose. The particle size distribution is regulated by the droplet size distribution and the lactose concentration in the solution, while the allergen content can be chosen independently. Thus, the Fraunhofer scientists have created a universal tool which provides them with the possibility to create atmospheres containing allergenic particles of arbitrary sizes containing a variety of different allergens. By choosing particle sizes preferentially depositing in the nose (above 10 µm) or the lungs (5 to 10 µm), and selecting allergen concentrations commonly found in the environment, it is possible to build up challenge atmospheres for a large variety of indications. The first clinical application of this new method will be to create an atmosphere simulating the natural exposure to house dust mite allergens. The challenge aerosol will be composed of lactose as carrier material and the two major allergens Der p1 and Der p2 of house dust mites originating from a licenced allergen extract for inhaled challenge.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
18
0 SQE/qm for 4 hours 250 SQE/qm for 4 hours 500 SQE/qm for 4 hours 1000 SQE/qm for 4 hours
Fraunhofer-Institute for Toxicology and Experimental Medicine
Hanover, Germany
Total nasal symptom score (TNSS)
To assess the effect of a 4 hour-environmental allergen challenge with house dust mite extract in an ECC on the total nasal symptom score (TNSS), defined as the sum of obstruction, rhinorrhea, itch, and sneeze, each of which has been scored on a scale from 0 to 3.
Time frame: During 4 hours of challenge
Rhinomanometry
To assess the effect of a 4-hour-environmental allergen challenge with house dust mite extract.
Time frame: During 4 hours of challenge
visual analogue scale (VAS) for total nasal symptoms
To assess the effect of a 4-hour-environmental allergen challenge with house dust mite extract
Time frame: During 4 hours of challenge
Nasal secretion
To assess the effect of a 4-hour-environmental allergen challenge with house dust mite extract.
Time frame: during 4 hours of challenge
Exhaled Nitric Oxide (NO)
To assess the effect of a 4-hour-environmental allergen challenge with house dust mite extract.
Time frame: during and up to 24 hours after challenge
FEV1
To assess the effect of a 4-hour-environmental allergen challenge with house dust mite extract.
Time frame: during and up to 24 hours after challenge
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