Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis
NCT ID: NCT04869436
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
27 participants
INTERVENTIONAL
2021-07-19
2025-12-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Chronic rhinosinusitis with Nasal Polyps
* Olfactory loss
* Clinical indication for treatment with Dupilumab
Exclusion Criteria
* Sinonasal malignancies
* Trauma
* Idiopathic olfactory loss
* Use of cocaine
* COVID-19 related olfactory loss
* Pregnancy
18 Years
ALL
No
Sponsors
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Mount Sinai Hospital, Canada
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Leigh Sowerby
Principal Investigator
Principal Investigators
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Leigh J Sowerby, MD, FRCS
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Hospital London, ON, Canada
Locations
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St. Joseph's Health Care
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Leigh J Sowerby
Role: primary
Other Identifiers
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3618
Identifier Type: -
Identifier Source: org_study_id