Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status and phase: Enrolling; Phase 4

Conditions: Chronic Rhinosinusitis With Nasal Polyps; Olfactory Disorder

Treatments: Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Study type: Interventional

Funder types: Other

Identifiers

NCT04869436

3618

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Dupilumab group

Experimental group

Description:

Patients with CRSwNP will have an initial dose of 600 mg of dupilumab, and 5 additional doses of 300mg every 4 weeks for 6 months.

Treatment:

Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]