NCT05245175

Impact of Carrier Solutions for House Dust Mite Allergen on Allergic Reactions

Assessment of Impact of Different Carrier Solutions for House Dust Mite Allergen (HDM) Challenge on Allergic Reactions in Patients with HDM Allergic Rhinitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Single-blind, within-block randomized, clean-air-controlled study to assess the effect of lactose and sodium chloride particles in patients with allergic rhinitis on nasal symptoms when challenged in the Fraunhofer Allergen Challenge Chamber

Detailed description

Allergen Challenge Chambers (ACC) are used worldwide since many years to test anti-allergic treatment in early clinical development. ACCs provide the advantage of controlled atmospheres with stable allergen load and highly reproducible symptoms during challenges. The Fraunhofer ACC has been used since more than 20 years to test a range of different anti-allergic treatments, mostly using pollen challenges. For house dust mite (HDM) challenges, a carrier solution containing lactose or sodium chloride is reconstituted with commercially available HDM allergen. The solution is spray-dried to create allergen loaded lactose or sodium chloride particles of a determined size. Those particles are distributed in the ACC. Whether lactose or sodium chloride particles alone could induce nasal irritation during allergen challenges, has not been examined. Should allergen-free carrier solutions contribute to nasal symptoms, study results might be confounded. Even more so, if one carrier solution caused more nasal irritation than the other. To determine if allergen-free carrier solutions alone irritate the nasal mucosa, we expose subjects with allergic rhinitis and house dust mite allergy to three different atmospheres: (1) lactose particles alone, (2) sodium chloride particles alone, and (3) clean air. Also, we aim to document nasal symptoms during challenges with HDM-containing carrier solutions to decide on the best carrier option for future clinical trials.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
OTHER	Sodium chloride particles	Patients are exposed to sodium chloride particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.
OTHER	Lactose particles	Patients are exposed to lactose particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.
OTHER	Clean air	Patients are exposed to clean air for 4 hours in the Fraunhofer Allergen Challenge Chamber.
OTHER	Sodium chloride particles with house dust mite	Patients are exposed to sodium chloride particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.
OTHER	Lactose particles with house dust mite	Patients are exposed to lactose particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Timeline

• Start date: 2022-02-22
• Primary completion: 2022-04-13
• Completion: 2022-04-13
• First posted: 2022-02-17
• Last updated: 2024-10-15

Locations

1 site across 1 country: Germany