Chronic Rhinosinusitis With Nasal PolypsPhase 4NCT05964465
Mechanisms of Smell Improvement With Dupilumab.
A Phase 4 study testing Dupilumab in people with Chronic Rhinosinusitis With Nasal Polyps, run by Medical University of South Carolina at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2023to 30 Jan 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- Meet criteria for CRSwNP as defined by ICAR-21
- 2 out of 4 cardinal symptoms for ≥12 weeks
- Visible evidence of inflammation on endoscopy or imaging
- Bilateral visible nasal polyps ≥1 in each nasal cavity (0-4 scale each side)
- Olfaction score ≥1 (0-3 scale)
- Candidate for treatment with dupilumab for CRSwNP
- Elected to proceed with dupilumab for treatment of CRSwNP
Who cannot join
- Prior use of dupilumab
- Previous treatment with another biologic medication for CRSwNP or asthma within 6 months
- Any nasal or sinus surgery within the last 3 months
- Oral corticosteroid use within the last 1 month
- Current pregnancy, breast-feeding, or plan to become pregnant during next 3 months
- Presence of antrochoanal nasal polyps; acute rhinosinusitis; upper respiratory infection;
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- Allergic granulomatous angiitis/eosinophilic granulomatosis with polyangiitis;
- Granulomatosis with polyangiitis; cystic fibrosis; Young syndrome;
- Kartagener syndrome; or dyskinetic cilia syndrome
- Poorly controlled asthma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22904
About this study
Official title: 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 olfactory cleft inflammation.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Dupilumab
- Keywords
- Chronic Rhinosinusitis, Nasal Polyps, dupilumab
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Monoclonal antibody blocking interleukin 4 and interleukin 13
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2. Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Volumetric Olfactory Cleft Opacification Based on CT.
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 and lower values indicating less inflammation and improvement.
Measured: Baseline and Week 12 (3 months post-treatment)
Change in Olfactory Cleft Endoscopy Score Based on Nasalendoscopy.
Subjects will have sinonasal endoscopy at baseline and every follow up visit. This procedure allows visual inspection of the sinus mucosal lining and grading of polyps, including the olfactory cleft. Results for each side will be recorded separately and combined for a final Olfactory Cleft Endoscopy Scale (OCES) that ranges from 0-20, with higher scores representing increased disease severity.
Measured: 3 months post-treatment
Change in Olfactory Cleft Mucus IL-13 Concentration
Olfactory cleft mucus samples were collected under endoscopic guidance at Baseline, Week 2, and Week 12. IL-13 concentrations were measured using a commercially available LegendPlex Th2 Cytometric Bead Array according to the manufacturer's instructions. The outcome reported here represents IL-13 concentration measured at Baseline and Week 12 to evaluate change after 3 months of dupilumab treatment.
Measured: Baseline and Week 12 (3 months post-treatment)
Change in Lund-Kennedy Endoscopy Score.
Subjects will have sinonasal endoscopy at baseline and every follow up visit. This procedure allows visual inspection of the sinus mucosal lining and grading of polyps, including the olfactory cleft. Results for each side will be recorded separately and combined for a final Lund-Kennedy endoscopy score (LKES) that ranges from 0-20, with higher scores representing increased disease severity.
Measured: 3 months post-treatment
Change in Overall Polyp Score From Sinonasal Endoscopy
Overall Nasal Polyp Score (NPS) was assessed by sinonasal endoscopy. Polyps were graded separately in each nasal cavity on a scale from 0 to 4 and summed to calculate a total bilateral score ranging from 0 to 8. Higher scores indicate greater nasal polyp burden and more severe disease, while lower scores indicate less disease and improvement.
Measured: Baseline and Week 12 (3 months post-treatment)
Secondary outcomes (2)
Correlation Between Change in Olfactory Cleft Mucus IL-13 Level and Sniffin' Sticks TDI Score
Quantitative psychophysical olfactory testing was performed using the Sniffin' Sticks Test. This validated test assesses odor threshold (T), odor discrimination (D), and odor identification (I). Individual component scores are summed to generate a Total TDI Score that reflects overall olfactory function, with higher scores indicating better olfactory function. The correlation between olfactory cleft mucus IL-13 levels and change in Total TDI Score from Baseline to Week 12 was assessed using Spearman correlation.
Measured: Baseline and Week 12 (3 months post-treatment)
Correlation Between Change in IL13 Level and QOD-NS Score
Olfactory-specific quality of life was assessed using the Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS), a validated patient-reported outcome measure of olfactory-specific quality of life. The QOD-NS total score ranges from 0 to 51, with higher scores indicating better olfactory-specific quality of life and lower scores indicating greater olfactory-related impairment. The correlation between change in olfactory cleft mucus IL-13 level and change in QOD-NS score from Baseline to Week 12 was assessed using Spearman correlation.
Measured: Baseline and Week 12 (3 months post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start10 Aug 2023
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaun Nguyen, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964465
- Sponsor's protocol ID
- Pro00125142
- Status last verified
- Jul 2026
- First submitted
- 15 Feb 2023
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No