The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab
Who is this study for? Adult patients with Chronic Rhinosinusitis with Nasal Polyps
What treatments are being studied? Dupilumab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients older than 18 years old
• Chronic rhinosinusitis with Nasal Polyps
• Olfactory loss
• Clinical indication for treatment with Dupilumab
Locations
Other Locations
Canada
St. Joseph's Health Care
RECRUITING
London
Contact Information
Primary
Cristian Dihel, MD
cristian.dihel@sjhc.london.on.ca
+15196466100
Time Frame
Start Date: 2021-07-19
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 27
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Mount Sinai Hospital, Canada
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's