Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04869436

Collaborator

Mount Sinai Hospital, Canada (Other)

Enrollment

Location

Arm

22.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Rhinosinusitis With Nasal Polyps Olfactory Disorder	Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single group 6 months treatment with Dupilumab.Single group 6 months treatment with Dupilumab.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 19, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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)

Arm

Intervention/Treatment

Experimental: 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.

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)

Outcome Measures

Primary Outcome Measures

Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24. [Baseline, 12 weeks and 24 weeks.]
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.

Secondary Outcome Measures

Change from Baseline in the Nasal Polyps score at weeks 12 and 24. [Baseline, 12 weeks and 24 weeks.]
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] ).
Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24. [Baseline, 12 weeks and 24 weeks.]
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
Change from Baseline in the QOD-NS at weeks 12 and 24. [Baseline, 12 weeks and 24 weeks.]
Quality of Olfactory Disorders - negative symptoms (questionnaire)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Health Care	London	Ontario	Canada	N5A 4V2

Sponsors and Collaborators

Lawson Health Research Institute
Mount Sinai Hospital, Canada

Investigators

Principal Investigator: Leigh J Sowerby, MD, FRCS, St. Joseph's Hospital London, ON, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Leigh Sowerby, Principal Investigator, Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT04869436

Other Study ID Numbers:

3618

First Posted:

May 3, 2021

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Nasal Polyps

Antibodies, Monoclonal

Study Results

No Results Posted as of Aug 23, 2022