Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

NCT04869436 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 3618
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Olfactory Disorder

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.

  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.

  Baseline, 12 weeks and 24 weeks.

Secondary Outcomes (3)

• Change from Baseline in the Nasal Polyps score at weeks 12 and 24.

  Baseline, 12 weeks and 24 weeks.

• Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.

  Baseline, 12 weeks and 24 weeks.

• Change from Baseline in the QOD-NS at weeks 12 and 24.

  Baseline, 12 weeks and 24 weeks.

Study Arms (1)

Dupilumab group

EXPERIMENTAL

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.

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

Interventions

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] DRUG

Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks)

Dupilumab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years old
• Chronic rhinosinusitis with Nasal Polyps
• Olfactory loss
• Clinical indication for treatment with Dupilumab

You may not qualify if:

• Patients with olfactory loss from other causes such as:
• Sinonasal malignancies
• Trauma
• Idiopathic olfactory loss
• Use of cocaine
• COVID-19 related olfactory loss
• Pregnancy

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Mount Sinai Hospital, Canada: collaborator

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N5A 4V2, Canada

RECRUITING

MeSH Terms

Interventions

dupilumab

Study Officials

• Leigh J Sowerby, MD, FRCS

  St. Joseph's Hospital London, ON, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristian Dihel, MD

CONTACT

+15196466100; cristian.dihel@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single group 6 months treatment with Dupilumab.

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: July 19, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)