NCT01275456

Validation of an Environmental Exposure Chamber for Inhalation Studies With House Dust Mite Allergen in Patients With Allergic Rhinitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Allergy to House Dust Mite

Interventions

Type	Name	Description
PROCEDURE	Exposure to house dust mite	0 SQE/qm for 4 hours 250 SQE/qm for 4 hours 500 SQE/qm for 4 hours 1000 SQE/qm for 4 hours

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2011-01-12
• Last updated: 2011-07-06

Locations

1 site across 1 country: Germany