Montefiore Medical Center
The Bronx, New York, 10461, United States
Location status: Recruiting
NCT Number: NCT05246267
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
Interested in participating?
Request Info18 year–99 year
All sexes
Observational
The Bronx, New York, 10461, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard of care treatment with dupilumab
Time frame: at 2, 16, 36, and 52 weeks of treatment
Measure changes in SNOT-22 values from baseline
Time frame: at 2, 16, 36, and 52 weeks of treatment
Measure changes in UPSIT scores from baseline
Time frame: at 2, 16, 36, and 52 weeks of treatment
Measure changes in the NPF values from baseline
Time frame: at 2, 16, 36, and 52 weeks of treatment
Measure changes in uLTE4 levels from baseline
Time frame: at 2, 16, 36, and 52 weeks of treatment
Measure changes in peripheral blood eosinophil counts from baseline
Time frame: at 2, 16, 36, and 52 weeks of treatment
Measure changes in IgE levels from baseline
Contact information is provided by the study sponsor or research team.
Montefiore Medical Center
Other
Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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