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Recruiting NCT04869436

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Phase IV Interventional Chronic Rhinosinusitis With Nasal Polyps Olfactory Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT].
Who it may be relevant to
Registry conditions: Chronic Rhinosinusitis With Nasal Polyps, Olfactory Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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)

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • Change from Baseline in the Nasal Polyps score at weeks 12 and 24. [Time frame: Baseline, 12 weeks and 24 weeks.]
  • Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24. [Time frame: Baseline, 12 weeks and 24 weeks.]
  • Change from Baseline in the QOD-NS at weeks 12 and 24. [Time frame: Baseline, 12 weeks and 24 weeks.]

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
  • Trauma
  • Idiopathic olfactory loss
  • Use of cocaine
  • COVID-19 related olfactory loss
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • St. Joseph's Health Care — London

Identifiers

NCT: NCT04869436 · 3618

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗