drugset / Trial / NCT04869436
Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis
Phase 4
Recruiting
27 enrolled
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Mount Sinai Hospital, Canada · collab
NaSingle-groupOpen-labelTreatment
Summary
The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the Otolaryngology Clinic (Baseline, 3 months and 6 months). The primary endpoint will be the TDI score. Nasal polyp score, Quality of Olfactory Disorders - negative symptoms (QOD-NS symptom scores), SNOT-22 will be secondary endpoints.
Timeline
- Start
- 2021-07-19
- Primary completion
- 2025-09-01
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |