Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964465
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-02-15
Brief Title:
Mechanisms of Smell Improvement With Dupilumab
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Mechanisms of Smell Improvement With Dupilumab
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with chronic sinusitis with nasal polyps CRSwNP The investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation
Detailed Description:
Post-marketed administration of dupilumab FDA approved medication for CRSwNP in patients with Chronic Rhinosinusitis with Nasal Polyps CRSwNP will result in significant improvement in objective measures of olfactory cleft inflammation and psychophysical olfaction The investigators seek to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with CRSwNP The investigators also want to determine whether change in olfactory cleft inflammation correlates with improvement in olfaction one of the cardinal symptoms of CRSwNP at 3 months The investigators hypothesize that after 3 months of treatment with dupilumab non-inflammatory factors will explain a significant degree of variation in residual clinical olfaction Additionally the investigators want to explore the determinants of ongoing olfactory loss after 3 months of treatment with attention to non-inflammatory factors The investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation Specifically the investigators expect to show that reduction in olfactory cleft inflammation is the result of reduction in IL13 levels in olfactory cleft mucus Finally the investigators expect to show that most of the variation in post-treatment olfaction can be explained by non-inflammatory measures that are independent of CRSwNP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None