Impact of Carrier Solutions for House Dust Mite Allergen on Allergic Reactions
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Hypersensitivity
Study type: Interventional

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.
    

Intervention name(s): Sodium chloride particles; Lactose particles; Clean air; Sodium chloride particles with house dust mite; Lactose particles with house dust mite
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Patients are exposed to sodium chloride particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.; Patients are exposed to lactose particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.; Patients are exposed to clean air for 4 hours in the Fraunhofer Allergen Challenge Chamber.; Patients are exposed to sodium chloride particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.; Patients are exposed to lactose particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 18 patients will be exposed 5 times in the Allergen Challenge Chamber. The 5 exposures are divided into 2 blocks. The first block consists of 3 challenges with sodium chloride particles, lactose particles, and clean air to address the primary and secondary objectives. The second block consists of 2 further challenges with D. pteronyssinus coupled with either sodium chloride particles or lactose particles to address exploratory objectives.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Allergen Challenge Chamber; House dust mite; Sodium chloride