NCT04869436

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps
• Olfactory Disorder

Interventions

Type	Name	Description
DRUG	Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]	Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks)

Timeline

• Start date: 2021-07-19
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2021-05-03
• Last updated: 2024-12-20

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study