Clinical Trials

Inclusion Criteria:

• Patients 18 years old or older.
• Male or female gender.
• Confirmed diagnosis of AERD based on aspirin challenge or strong clinical history.
• Patient must elect to be treated with aspirin desensitization therapy for their AERD.
• Patient must undergo endoscopic sinus surgery.
• Patient does not miss more than 48 hours of aspirin therapy during the study period.
• Patient must complete all pre-operative and post-operative diagnostic testing including CBC with differential, urine LTE-4, urine 11 beta-prostaglandin F2alpha, IgE, spirometry, pulmonary function testing, nasal endoscopy, and SNOT-22 questionnaires.
• Treatment with topical steroid irrigation or spray as well as oral corticosteroids as long the treatment was completed at least 14 days before endoscopic sinus surgery or study diagnostic testing including labs, pulmonary testing, and endoscopic exams. Patient may have taken oral or nasal antihistamines. Patients may have taken montelukast 10 mg dosage prior to the study.

Exclusion Criteria:

• Unconfirmed AERD based on strong clinical history or positive aspirin challenge.
• Refusal to used aspirin desensitization.
• More the 48 hours without aspirin during the study trial.
• Concomitant use of biologics such as dupilumab, mepolizumab, or omalizumab.
•  More than 6-week delay in providing diagnostic testing including endoscopy, labs, spirometry.
• Inability to complete 12 months of aspirin therapy based on patient preference, adverse reaction, or significant worsening of symptoms on therapy.
• Patients are clearly defined as having AERD based on positive aspirin challenge and/or a strong clinical history of aspirin intolerance. For patients with a clinical history of aspirin intolerance there needs to be a documented history of oral intact of aspirin and a significant gastroenterology or respiratory symptom which occurs within 4-6 hours of medication intact. Thes patient must have a diagnosis of asthma and nasal polyps in addition to the intolerance to aspirin.
• Pregnancy, allergic rhinitis based on skin prick testing, additional pulmonary co-morbidities such as bronchitis, cystic fibrosis, bronchiectasis, or chronic obstructive pulmonary disease. Patients with unstable asthma.
• Inability to understand study procedures and to comply with them for the entire length of the study.
• Patients who use oral prednisone within 14 days of diagnostic testing. Inability to complete or tolerate aspirin therapy for 12 months. Previous use of biologics including omalizumab, mepolizumab, and dupilumab ever.
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/3/23. Questions regarding updates should be directed to the study team contact.