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Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Primary Purpose

Chronic Rhinosinusitis With Nasal Polyps, Olfactory Disorder

Status

Recruiting

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

St. Joseph's Health CareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dupilumab group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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] ).

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

Change from Baseline in the QOD-NS at weeks 12 and 24.

Quality of Olfactory Disorders - negative symptoms (questionnaire)

Full Information

NCT ID

NCT04869436

First Posted

April 28, 2021

Last Updated

September 22, 2023

Sponsor

Lawson Health Research Institute

Collaborators

Mount Sinai Hospital, Canada

1. Study Identification

Unique Protocol Identification Number

NCT04869436

Brief Title

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 19, 2021 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

Collaborators

Mount Sinai Hospital, Canada

4. Oversight

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

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Rhinosinusitis With Nasal Polyps, Olfactory Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Single group 6 months treatment with Dupilumab.

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dupilumab group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Intervention Description

Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, 12 weeks and 24 weeks.

Secondary Outcome Measure Information:

Title

Change from Baseline in the Nasal Polyps score at weeks 12 and 24.

Description

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] ).

Time Frame

Baseline, 12 weeks and 24 weeks.

Title

Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.

Description

Time Frame

Baseline, 12 weeks and 24 weeks.

Title

Change from Baseline in the QOD-NS at weeks 12 and 24.

Description

Quality of Olfactory Disorders - negative symptoms (questionnaire)

Time Frame

Baseline, 12 weeks and 24 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Taciano Rocha, PhD

Phone

+15196466100

Ext

61125

taciano.rocha@sjhc.london.on.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leigh J Sowerby, MD, FRCS

Organizational Affiliation

St. Joseph's Hospital London, ON, Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Health Care

City

London

State/Province

Ontario

ZIP/Postal Code

N5A 4V2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leigh J Sowerby

First Name & Middle Initial & Last Name & Degree

Leigh J Sowerby, MD

First Name & Middle Initial & Last Name & Degree

Brian Rotenberg, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to make IPD available.

Learn more about this trial

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

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