Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps; Olfactory Disorder
• Intervention / Treatment: Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Taciano Rocha, PhD; Phone Number: 61125 +15196466100; Email: taciano.rocha@sjhc.london.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N5A 4V2
      • Recruiting
      • St. Joseph's Health Care
      • Contact: Leigh J Sowerby
      • Principal Investigator: Leigh J Sowerby, MD
      • Sub-Investigator: Brian Rotenberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Mount Sinai Hospital, Canada
• Investigators: Principal Investigator: Leigh J Sowerby, MD, FRCS, St. Joseph's Hospital London, ON, Canada

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Polyps; Rhinitis; Sinusitis; Nasal Polyps; Rhinosinusitis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: 3618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes