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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Monoclonal antibody blocking interleukin 4 and interleukin 13
Medical University of South Carolina
Charleston, South Carolina, United States
University of Virginia
Charlottesville, Virginia, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: Baseline and Week 12 (3 months post-treatment)
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.
Time frame: 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.
Time frame: Baseline and Week 12 (3 months post-treatment)