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Completed

NCT Number: NCT05964465

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.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of South Carolina, Charleston, South Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • Allergic granulomatous angiitis/eosinophilic granulomatosis with polyangiitis;
  • Granulomatosis with polyangiitis; cystic fibrosis; Young syndrome;
  • Kartagener syndrome; or dyskinetic cilia syndrome
  • Poorly controlled asthma

Treatment and study plan

Dupilumab

Drug

Monoclonal antibody blocking interleukin 4 and interleukin 13

Primary outcomes

  1. Change in Volumetric Olfactory Cleft Opacification Based on CT.

    Time frame: Baseline and Week 12 (3 months post-treatment)

    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.

  2. Change in Olfactory Cleft Endoscopy Score Based on Nasalendoscopy.

    Time frame: 3 months post-treatment

    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.

  3. Change in Olfactory Cleft Mucus IL-13 Concentration

    Time frame: Baseline and Week 12 (3 months post-treatment)

    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.

  4. Change in Lund-Kennedy Endoscopy Score.

    Time frame: 3 months post-treatment

    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.

  5. Change in Overall Polyp Score From Sinonasal Endoscopy

    Time frame: Baseline and Week 12 (3 months post-treatment)

    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.

Secondary outcomes

  1. Correlation Between Change in Olfactory Cleft Mucus IL-13 Level and Sniffin' Sticks TDI Score

    Time frame: Baseline and Week 12 (3 months post-treatment)

    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.

  2. Correlation Between Change in IL13 Level and QOD-NS Score

    Time frame: Baseline and Week 12 (3 months post-treatment)

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Mechanisms of Smell Improvement With Dupilumab

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2023
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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