Recruiting

Dupilumab

Sponsor:

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

Code:

NCT04869436

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Olfactory Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Study Details

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

Study ID

NCT04869436

Start date

Jul 19, 2021

Status verified date

Dec, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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)

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 and Locations

Central contacts

Cristian Dihel, MD

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

Locations

St. Joseph's Health Care

Recruiting

London, Ontario, Canada, N5A 4V2

Principal Investigator:

Leigh J Sowerby, MD

More Information

Sponsor

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

Last update posted

Dec 20, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-12-20.