Anakinra as a Rescue Treatment for Nasal Allergen Challenge-induced Airway Inflammation

NCT04035109 Phase 1/Phase 2 WITHDRAWN

Participants with mild asthma who are sensitized to either house dust mite or cat hair allergen will undergo nasal instillation of the allergen to elicit nasal allergy symptoms. The participants will be treated in a cross-over fashion with either placebo (saline) or anakinra to determine if anakinra will reduce nasal airway eosinophil recruitment, eosinophil activation, release of inflammatory mediators, mucins, and gene expression changes in epithelial cells.

Details

Lead sponsor	University of North Carolina, Chapel Hill
Phase	Phase 1/Phase 2
Status	WITHDRAWN
Start date	2019-12-16
Completion	2023-10

Conditions

• Asthma, Allergic

Interventions

• Anakinra
• Preservative-free 0.9% sodium chloride (Placebo)
• House dust mite allergen
• Cat hair allergen

Primary outcomes

• Change in eosinophils per milliliter of Nasal Lavage Fluid (NLF) — 6 hours post-allergen challenge versus pre-allergen challenge
  Allergen-induced eosinophil recruitment will be measured by measuring eosinophil content of fluid obtained from lavage of the nares, comparing pre-challenge lavage samples to samples obtained 6 hours after allergen challenge