Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis

Study Overview
=================
Brief Summary
-----------------
The central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a cohort of mostly ethnical and racial minority patients with CRSwNP

Detailed Description
-----------------
First, it will confirm the effectiveness of dupilumab in the treatment of CRSwNP in ethnic and racial minority patients who have traditionally been underrepresented in existing clinical trials of biologics in CRSwNP Second, this research will establish a biomarker of therapeutic response to dupilumab identifying the biological effect of dupilumab in CRSwNP patients and its association with symptom improvement. Finally, the investigators will measure the effect of dupilumab on asthma symptoms and lung function in patients with CRSwNP and comorbid asthma. There will be a screening visit, followed by a baseline visit where the medication will be given. Follow-up visits will be scheduled at 2 weeks and then 16 weeks from baseline. Long-term visits will take place in 36 and 52 weeks.

Official Title
-----------------
Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Conditions
-----------------
Chronic Rhinosinusitis With Nasal Polyps

Intervention / Treatment
-----------------
* Biological: Dupilumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab. Patients aged 18 years and older. Patient willing to provide consent to be a participant in the study. Patients with insurance that allows Dupilumab coverage or Dupilumab coverage obtained through Dupixent MyWay Program Exclusion Criteria: Age under 18 Suspected or diagnosed allergic fungal rhinosinusitis. Suspected or diagnosed cystic fibrosis. Dupilumab coverage denied through insurance or Dupixent MyWay Program Patients who required a steroid taper in the preceding 30 days. However, patients on chronic steroids less or equal to 20 mg of prednisone daily, are eligible. Patients who were on a different biologic medication in the preceding 3 months. Patients with a diagnosis of EGPA/Churg-Strauss Syndrome Pregnant patients Patients with inverted papilloma growth

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab. | Biological: Dupilumab<br>* Standard of care treatment with dupilumab<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome | Measure changes in SNOT-22 values from baseline | at 2, 16, 36, and 52 weeks of treatment | 
| Change in University of Pennsylvania Smell Identification Test (UPSIT) scores, scale 0-40, lower is worse outcome values | Measure changes in UPSIT scores from baseline | at 2, 16, 36, and 52 weeks of treatment | 
| Change in nasal peak flow (NPF) value (L/min) | Measure changes in the NPF values from baseline | at 2, 16, 36, and 52 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary levels of Leukotriene E4 (uLTE4) levels in ug/L | Measure changes in uLTE4 levels from baseline | at 2, 16, 36, and 52 weeks of treatment | 
| Change in peripheral blood eosinophil counts in k/uL | Measure changes in peripheral blood eosinophil counts from baseline | at 2, 16, 36, and 52 weeks of treatment | 
| Change in Immunoglobulin E (IgE) level in IU/mL | Measure changes in IgE levels from baseline | at 2, 16, 36, and 52 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRSwNP, dupilumab