Chronic Rhinosinusitis With Nasal Polyps, Olfactory Disorder
Conditions
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.
Interventions
Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks)
Sponsors
Mount Sinai Hospital, Canada
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group 6 months treatment with Dupilumab.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Canada
Contacts
Primary ContactCristian Dihel, MD
Outcome results
None listed