RecruitingPhase 4NCT04869436

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab


Sponsor

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

Enrollment

27 participants

Start Date

Jul 19, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • Patients older than 18 years old
  • Chronic rhinosinusitis with Nasal Polyps
  • Olfactory loss
  • Clinical indication for treatment with Dupilumab

Exclusion Criteria7

  • Patients with olfactory loss from other causes such as:
  • Sinonasal malignancies
  • Trauma
  • Idiopathic olfactory loss
  • Use of cocaine
  • COVID-19 related olfactory loss
  • Pregnancy

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Interventions

DRUGDupilumab 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)


Locations(1)

St. Joseph's Health Care

London, Ontario, Canada

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NCT04869436


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