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Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

NCT04869436 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-12-20

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Leigh J Sowerby, MD, FRCS · St. Joseph's Hospital London, ON, Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2025-09-01
Completion
2025-12-01
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04869436 on ClinicalTrials.gov