Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Phase 4

Recruiting

• Conditions: Chronic Rhinosinusitis With Nasal Polyps; Olfactory Disorder
• Interventions: Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

• Registration Number: NCT04869436
• Lead Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Study Start: 2021-07-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dupilumab group	Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]	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 Measures

Name	Time	Method
Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.	Baseline, 12 weeks and 24 weeks.	The Sniffin' Sticks test involves testing odor for threshold and discrimination whilst blind folded and secondly odor identification. The sum of four odors responses ranges from 0-16. The sum of total score from odor Threshold, Discrimination and Identification (TDI) is a maximum of 48 points. The total score is graded as; normosmia equals or over 30.5 points, hyposmia 16.5-30 points and anosmia less than 16.5 points.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in the Nasal Polyps score at weeks 12 and 24.	Baseline, 12 weeks and 24 weeks.	Nasal Polyps score is the sum of the right and left nostril scores (endoscopic assessment). Total score ranges from 0 (no polyps) to 8 (large polyps on for each nostril \[4+4\] ).
Change from Baseline in the QOD-NS at weeks 12 and 24.	Baseline, 12 weeks and 24 weeks.	Quality of Olfactory Disorders - negative symptoms (questionnaire)
Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.	Baseline, 12 weeks and 24 weeks.	SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis on patients' quality of life. Patient grades the impact of 22 potential symptoms in their life, by choosing from 0 \[no problem\] to 5 \[problem as bad as it can be\]. Highest possible score is 10 (worst quality of life); minimal clinically important change ≥ 8.90

Trial Locations

Locations (1)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada