Mechanisms of Smell Improvement With Dupilumab.
Completed · Phase 4
Conditions studied: Chronic Rhinosinusitis With Nasal Polyps
In brief
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 study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation.
Key facts
- Study ID
- NCT05964465
- Run by
- Medical University of South Carolina
- People needed
- 60
- Starts
- 2023-08-10
- Expected to finish
- 2025-01-30
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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