Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study ID
NCT04869436
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Rhinosinusitis With Nasal Polyps
  • Olfactory Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 19, 2021
Status verified
Dec 2024
Primary completion
Sep 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab group
    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.

Primary Outcome Measure

Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24. [ Time Frame: Baseline, 12 weeks and 24 weeks. ]

Central Contacts

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