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NCT05964465 · ClinicalTrials.gov registry record · Phase 4
Mechanisms of Smell Improvement With Dupilumab.
A Phase 4 study of Chronic Rhinosinusitis With Nasal Polyps, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT05964465: Completed Phase 4 study of Chronic Rhinosinusitis With Nasal Polyps, sponsored by Medical University of South Carolina.
NCT05964465 is a Phase 4 study of Chronic Rhinosinusitis With Nasal Polyps that has completed, run by Medical University of South Carolina. The registered enrollment target is 60 participants, below the 137-participant average among 11 other Chronic Rhinosinusitis With Nasal Polyps trials with a reported enrollment target (56% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05964465, a Phase 4 study of Chronic Rhinosinusitis With Nasal Polyps, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Non-contrast sinus computed tomography (CT) scans were obtained at Baseline and Week 12. Volumetric analysis of the olfactory cleft was performed using previously described methods. Total olfactory cleft volume and air volume were measured to calculate percent olfactory cleft opacification as \[1 - (air volume/total olfactory cleft volume)\] × 100. Percent olfactory cleft opacification ranges from 0% to 100%, with higher values indicating greater olfactory cleft inflammation and disease severity
Conditions Studied
Interventions
- DRUG Dupilumab
Study Locations (2)
South Carolina
- Medical University of South Carolina - Charleston
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-08-10 |
| Est. Completion | 2025-01-30 |
| Phase | Phase 4 |
What the finished NCT05964465 record still lists
NCT05964465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 137-participant average among 11 other Chronic Rhinosinusitis With Nasal Polyps trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Chronic Rhinosinusitis With Nasal Polyps appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab is the first listed.
NCT05964465 reports a single indexed study location in South Carolina, Virginia.
Frequently Asked Questions
What is clinical trial NCT05964465 about?
NCT05964465 is a clinical study titled "Mechanisms of Smell Improvement With Dupilumab.". 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...
What is the current status of trial NCT05964465?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2023-08-10. Estimated completion is 2025-01-30.
What conditions does trial NCT05964465 study?
This clinical trial studies the following conditions: Chronic Rhinosinusitis With Nasal Polyps.
What interventions are being tested in trial NCT05964465?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT05964465?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05964465 being conducted?
This trial has 2 study locations across South Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05964465's enrollment target sits among peer trials
60 8th of 11 higher than 3 of 11 other Chronic Rhinosinusitis With Nasal Polyps trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Rhinosinusitis With Nasal Polyps trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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