Status:
COMPLETED
Mechanisms of Smell Improvement With Dupilumab.
Lead Sponsor:
Medical University of South Carolina
Conditions:
Chronic Rhinosinusitis With Nasal Polyps
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study seeks to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with chronic sinusitis with nasal polyps (CRSwNP). The investigators expect this stu...
Detailed Description
Post-marketed administration of dupilumab (FDA approved medication for CRSwNP) in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) will result in significant improvement in objective me...
Eligibility Criteria
Inclusion
- Adults ≥18 years of age
- Meet criteria for CRSwNP as defined by ICAR-21
- 2 out of 4 cardinal symptoms for ≥12 weeks
- Visible evidence of inflammation on endoscopy or imaging
- Bilateral visible nasal polyps ≥1 in each nasal cavity (0-4 scale each side)
- Olfaction score ≥1 (0-3 scale)
- Candidate for treatment with dupilumab for CRSwNP
- Elected to proceed with dupilumab for treatment of CRSwNP
Exclusion
- Prior use of dupilumab
- Previous treatment with another biologic medication for CRSwNP or asthma within 6 months
- Any nasal or sinus surgery within the last 3 months
- Oral corticosteroid use within the last 1 month
- Current pregnancy, breast-feeding, or plan to become pregnant during next 3 months
- Presence of antrochoanal nasal polyps; acute rhinosinusitis; upper respiratory infection;
- Allergic granulomatous angiitis/eosinophilic granulomatosis with polyangiitis;
- Granulomatosis with polyangiitis; cystic fibrosis; Young syndrome;
- Kartagener syndrome; or dyskinetic cilia syndrome
- Poorly controlled asthma
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05964465
Start Date
August 10 2023
End Date
January 30 2025
Last Update
March 5 2025
Active Locations (2)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
2
University of Virginia
Charlottesville, Virginia, United States, 22904