Actively Recruiting
The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2024-12-20
27
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
L
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
M
Mount Sinai Hospital, Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the olfactory TDI score, which measures smell threshold, discrimination, and identification, in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who experience olfactory loss. This study follows patients receiving dupilumab treatment to understand its effects on smell and related symptoms. The study is sponsored by the London Health Sciences Centre Research Institute and Lawson Research Institute and is a Phase 4 clinical trial. Participants will receive dupilumab subcutaneously for six months, starting with an initial 600 mg dose followed by five 300 mg doses every four weeks. The treatment period includes three clinic visits: at baseline, 3 months, and 6 months. Researchers will closely monitor changes in the TDI score as the primary outcome, along with secondary measures such as nasal polyp score, the Sino-nasal outcome test-22 (SNOT-22), and the Quality of Olfactory Disorders - negative symptoms (QOD-NS) symptom scores. During the study, participants will visit the Otolaryngology Clinic three times for evaluations at baseline, 12 weeks, and 24 weeks. Assessments include smell tests using the Sniffin' sticks, nasal polyp scoring, and questionnaires about nasal and olfactory symptoms. These visits help track changes in smell, nasal symptoms, and quality of life. The total participation time spans six months, with ongoing monitoring of safety and treatment effects throughout this period.
CONDITIONS
Brief Title
Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years old
- Chronic rhinosinusitis with Nasal Polyps
- Olfactory loss
- Clinical indication for treatment with Dupilumab
You will not qualify if you...
- Sinonasal malignancies
- Trauma
- Idiopathic olfactory loss
- Use of cocaine
- COVID-19 related olfactory loss
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive Dupilumab subcutaneously with an initial 600 mg dose followed by five 300 mg doses every 4 weeks over 6 months.
6 visits (in-person) for drug administration every 4 weeks
Duration - Up to 24 weeks from baseline
Participants are monitored after treatment to assess changes in olfactory function and nasal polyp scores.
Visits at baseline, week 12, and week 24 for assessments
Trial Site Locations
Total: 1 location
1
St. Joseph's Health Care
London, Ontario, Canada, N5A 4V2
Actively Recruiting
Research Team
C
Cristian Dihel, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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