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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: 3 months post-treatment

    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.

  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 cytokine levels

    Time frame: 3 months post-treatment

    Under endoscopic guidance, a 1 × 2-cm Leukosorb filter paper (Pall Scientific, Port Washington, NY) strip will be placed into the olfactory cleft of each side, and kept in place for 3 minutes, as described in earlier studies. This will be done at baseline, 2 weeks, and 3 months. Olfactory cleft mucus inflammatory cytokine levels will be detected using commercially available LegendPlex Th2 Cytometric Bead Array (BioLegend, San Diego, CA) following the manufacturer's recommended protocol. This panel will include IL4, IL13, IL5 cytokines (among others). The assay will be carried out according to manufacturers' instructions and as previously described. The samples will be read on a Guava easyCyte 8HT flow cytometer (EMD Millipore) and analysis performed with LegendPlex software. Total IgE will be quantified via ELISA (GenWay Biotech. Inc, San Diego, CA).

  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: 3 months post-treatment.

    Overall polyp score on a 0-4 scale for each nostril (summed 0-8).

Secondary outcomes

  1. Correlation between change in olfactory cleft mucus IL13 level and Sniffin Sticks TDI

    Time frame: 3 months post-treatment

    Quantitative psychophysical olfactory testing will be performed using the "Sniffin' Sticks" test (Burghardt, Wedel, Germany). Testing will be performed by trained clinical research coordinators who routinely perform objective olfactory testing and will be done in a blinded fashion. This commercially available test battery measures odor threshold (OT), odor discrimination (OD) and odor identification (OI). The results will be combined for an overall TDI score. TDI will be correlated with OC IL13 levels.

  2. Correlation between change in IL13 level and QOD-NS score

    Time frame: 3 months post-treatment

    Olfactory-specific QOL will be assessed using the previously validated, short, modified version of the Questionnaire of Olfactory Disorders (QOD-NS) survey. This instrument was validated by Mattos and Soler and has been found to have criterion validity, internal consistency, and excellent reproducibility.

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
Feb 17, 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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