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Current Clinical Trials

Mechanisms of Dupilumab in AERD - effects on aspirin hypersensitivity response, with a focus on innate type 2 inflammatory responses 

Primary Investigator: Andrew A. White, FAAAAI, FACAAI
Co-Investigator: Taylor A. Doherty, MD, FAAAAI

Study Goals: (1) To evaluate the effect of Dupilumab on aspirin challenge/desensitization as measured by nasal inspiratory flow, symptom score, and spirometry. (2) To evaluate the effect of Dupilumab on innate lymphocyte type 2 (ILC2) cells and lipid mediators during aspirin challenge/desensitization.

Study Background: Aspirin-Exacerbated Respiratory Disease (AERD), although uncommon in the general population, is an important phenotype of severe asthma and nasal polyposis where it occurs in 15% of severe asthmatics, and up to 30% of those with nasal polyposis. An important therapy for AERD is aspirin therapy after desensitization (ADAT). This is an inexpensive and proven therapy to improve the burden of sinus disease in AERD. Aspirin desensitization is the mechanism by which tolerance is induced in AERD patients. This is a 1-2 day outpatient procedure whereby increasing doses of aspirin are administered and the patients invariably experience some degree of hypersensitivity reactions. 

It is important to understand the effect of medications on aspirin desensitization. It is known that the leukotriene modifier medications decrease the severity of the reactions in AERD. Other treatments such as antihistamines and the biologic agent omalizumab might have an effect on either blocking or blunting reactivity in AERD during desensitization. 

Dupilumab is a new respiratory biologic approved for atopic dermatitis, eosinophilic asthma, and nasal polyposis. As such, it is well situated to be used for many AERD patients whose disease cannot be well controlled. The effect of Dupilumab on the aspirin desensitization process and reaction is unknown and is the topic of this investigation.