The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab
Overview
- Phase
- Phase 4
- Intervention
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Sponsor
- London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Leigh Sowerby
Principal Investigator
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Eligibility Criteria
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
- •Idiopathic olfactory loss
- •Use of cocaine
- •COVID-19 related olfactory loss
- •Pregnancy
Arms & Interventions
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.
Intervention: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Outcomes
Primary Outcomes
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.
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 Outcomes
- Change from Baseline in the Nasal Polyps score 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.)
- Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.(Baseline, 12 weeks and 24 weeks.)