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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
| Mayo Clinic | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Biological | Standard of care treatment with dupilumab |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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60 patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab. These patients will be 18 years and older and will have insurance that allows Dupilumab coverage or Dupilumab coverage obtained through "Dupixent MyWay Program"
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Golda Hudes, MD | Contact | 866-633-8255 | ghudes@montefiore.org |
| Name | Affiliation | Role |
|---|---|---|
| Golda Hudes, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30810118 | Background | Fokkens W, Desrosiers M, Harvey R, Hopkins C, Mullol J, Philpott C, Alobid I, Anselmo-Lima WT, Bachert C, Baroody F, Bernal-Sprekelsen M, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Douglas R, Gevaert P, Hafner A, Hellings P, Joos G, Kalogjera L, Kern R, Knill A, Kocks J, Landis BN, Limpens J, Lebeer S, Lourenco O, Matricardi PM, Meco C, O Mahony L, Reitsma S, Ryan D, Schlosser R, Senior B, Smith T, Teeling T, Tomazic PV, Toppila-Salmi S, Wang DY, Wang D, Zhang L, Lund V. EPOS2020: development strategy and goals for the latest European Position Paper on Rhinosinusitis. Rhinology. 2019 Jun 1;57(3):162-168. doi: 10.4193/Rhin19.080. | |
| 26889651 |
| Label | URL |
|---|---|
| Racial and Ethnic Categories and Definitions for NIH Diversity Programs and for Other Reporting Purposes. 2015. | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2021 | Jan 26, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2021 | Jan 26, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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Nasal inferior turbinate tissue, fluid, and microbiome collection
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 |
| Background |
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| Result | Effect of 16-week Dupilumab Treatment on Sinonasal Respiratory Symptoms and Sense of Smell in Ethnically Diverse Patients with Chronic Rhinosinusitis with Nasal Polyposis |