Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04869436
• Other study ID #: 3618
• Status: Recruiting
• Phase: Phase 4
• Start date: July 19, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Lawson Health Research Institute
• Contact: Taciano Rocha, PhD
• Phone: +15196466100
• Email: taciano.rocha[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Olfactory Disorder
• Rhinosinusitis

Intervention

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)

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.	The Sniffin' Sticks test involves testing odor for threshold and discrimination whilst blind folded and secondly odor identification. The sum of four odors responses ranges from 0-16. The sum of total score from odor Threshold, Discrimination and Identification (TDI) is a maximum of 48 points. The total score is graded as; normosmia equals or over 30.5 points, hyposmia 16.5-30 points and anosmia less than 16.5 points.	Baseline, 12 weeks and 24 weeks.
Secondary	Change from Baseline in the Nasal Polyps score at weeks 12 and 24.	Nasal Polyps score is the sum of the right and left nostril scores (endoscopic assessment). Total score ranges from 0 (no polyps) to 8 (large polyps on for each nostril [4+4] ).	Baseline, 12 weeks and 24 weeks.
Secondary	Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.	SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis on patients' quality of life. Patient grades the impact of 22 potential symptoms in their life, by choosing from 0 [no problem] to 5 [problem as bad as it can be]. Highest possible score is 10 (worst quality of life); minimal clinically important change = 8.90	Baseline, 12 weeks and 24 weeks.
Secondary	Change from Baseline in the QOD-NS at weeks 12 and 24.	Quality of Olfactory Disorders - negative symptoms (questionnaire)	Baseline, 12 weeks and 24 weeks.