Clinical Trial: Mechanisms of Smell Improvement With Dupilumab.

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: Mechanisms of Smell Improvement With Dupilumab

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 Summary: 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.
Sponsor: Medical University of South Carolina

Current Primary Outcome: Non-contrast sinus computed tomography (CT) scans will be obtained at baseline and 3 month follow-up to provide 1mm cuts that can be formatted in coronal, sagittal, and axial planes.
Volumetric analysis of the OC will be performed utilizing equally spaced coronal CT images per our previously described protocols.
Total volume of the segmented 3-D olfactory cleft space will be calculated, as well as the volume of air within that space.
The percent opacification will be defined as [1-(total volume of air/total volume of olfactory cleft)] multiplied by 100.
Sinus opacification will be quantified using the Lund-Mackay CT scale.

Original Primary Outcome: Non-contrast sinus computed tomography (CT) scans will be obtained at baseline and 3 month follow-up to provide 1mm cuts that can be formatted in coronal, sagittal, and axial planes.
Volumetric analysis of the OC will be performed utilizing equally spaced coronal CT images per our previously described protocols.
Total volume of the segmented 3-D olfactory cleft space will be calculated, as well as the volume of air within that space.
The percent opacification will be defined as [1-(total volume of air/total volume of olfactory cleft)] multiplied by 100.
Sinus opacification will be quantified using the Lund-Mackay CT scale.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medical University of South Carolina

Dates:
Date Received: February 15, 2023
Date Started: August 10, 2023
Date Completion: August 10, 2023
Last Updated: September 06, 2023
Last Verified: September 01, 2023