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NCT Number: NCT04869436

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

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.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps Olfactory Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Joseph's Health Care

London, Ontario, N5A 4V2, Canada

Location status: Recruiting

Location contact

Brian Rotenberg, MD

SUB_INVESTIGATOR

Leigh J Sowerby

CONTACT

Leigh J Sowerby, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Drug

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

Primary outcomes

  1. 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.

    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 outcomes

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

    Time frame: 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] ).

  2. 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.

    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

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

    Time frame: Baseline, 12 weeks and 24 weeks.

    Quality of Olfactory Disorders - negative symptoms (questionnaire)

Study contacts

Contact information is provided by the study sponsor or research team.

Cristian Dihel, MD

CONTACT

[email protected]

+15196466100 ext. 61125

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Mount Sinai Hospital, Canada

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 3, 2021
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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