Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Rhinosinusitis With Nasal Polyps, Olfactory Disorder

Intervention / Treatment
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* Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group 6 months treatment with Dupilumab.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dupilumab group<br>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]<br>* Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks)<br>|

What is the study measuring?
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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. |