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Recruiting Phase 4 NCT04869436

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Trial Parameters

Condition Chronic Rhinosinusitis With Nasal Polyps
Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 27
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-07-19
Completion 2025-09-01
Interventions
Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Patients older than 18 years old * Chronic rhinosinusitis with Nasal Polyps * Olfactory loss * Clinical indication for treatment with Dupilumab Exclusion Criteria: Patients with olfactory loss from other causes such as: * Sinonasal malignancies * Trauma * Idiopathic olfactory loss * Use of cocaine * COVID-19 related olfactory loss * Pregnancy

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