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Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
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.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Montefiore Medical Center
The Bronx, New York, United States
Start Date
February 15, 2022
Primary Completion Date
June 1, 2026
Completion Date
June 1, 2026
Last Updated
January 22, 2026
60
ESTIMATED participants
Dupilumab
BIOLOGICAL
Lead Sponsor
Montefiore Medical Center
Collaborators
NCT06914908
NCT07125586
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06118554