This study aims to examine three key aspects of chronic rhinosinusitis with nasal polyps (CRSwNP): inflammation, tissue structure (histopathology), and remodeling.
By analyzing these tissue samples before and after treatment with intranasal corticosteroids (INCS), investiagtors hope to better understand how the nasal tissue changes and whether those changes are linked to improvements in symptoms. This information could help doctors create more personalized treatment plans for people with CRSwNP in the future.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Participants will use Budesonide twice daily
St Paul's Sinus Centre
Vancouver, British Columbia, Canada
Change in sinonasal inflammatory cytokine concentrations measured in nasal secretions using multiplex immunoassay
Sinonasal secretions will be collected via endoscopy-guided intranasal brushing using nasosorption sponges. Samples will be analyzed using the Luminex Bio-Plex Pro Human Cytokine Multiplex Assay and Luminex Human Magnetic Assay. Concentrations of inflammatory biomarkers will be quantified in pg/mL. The panel includes, but is not limited to: Interleukins (e.g., IL-4, IL-5, IL-6, IL-13) Interferon-gamma (IFN-γ) Transforming growth factor beta-1 (TGF-β1) Matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) Monocyte chemoattractant protein (MCP) Macrophage inflammatory proteins (MIP) Chemokine ligands (CCLs) Granulocyte colony-stimulating factor (G-CSF) Granulocyte-macrophage colony-stimulating factor (GM-CSF) Myeloperoxidase (MPO) will be measured separately using enzyme-linked immunosorbent assay (ELISA)
Time frame: Baseline to 6 months
Change in sinonasal histopathological score assessed using semi-quantitative histopathological evaluation of nasal biopsy specimens
Nasal biopsy specimens will be analyzed using standard histopathological techniques, including hematoxylin and eosin (H\&E) staining. Histopathological features will be evaluated by a qualified pathologist using a predefined semi-quantitative scoring system. The following parameters will be assessed: inflammatory cell infiltration (eosinophils, neutrophils, lymphocytes), epithelial integrity and damage, goblet cell hyperplasia, basement membrane thickening, subepithelial fibrosis, and edema. Each parameter will be scored on a scale from 0 to 3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Individual parameter scores will be summed to generate a total histopathological score, with higher scores indicating greater inflammation and tissue remodeling.
Time frame: Baseline to 6 months
Remodeling features
Sinonasal remodeling features will be evaluated using nasal endoscopy and the Modified Lund-Kennedy (MLK) scoring system. The MLK scale assesses endoscopic findings including edema, discharge, crusting, and scarring. Each parameter is scored from 0 to 2 (0 = absent, 1 = mild, 2 = severe), with a total score ranging from 0 to 8. Higher scores indicate worse sinonasal disease severity and greater remodeling.
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Time frame: 6 months
SNOT-22
Sinonasal symptoms will be assessed using the 22-item Sinonasal Outcome Test (SNOT-22), a validated patient-reported outcome measure evaluating symptom severity and health-related quality of life in patients with chronic rhinosinusitis. Each of the 22 items is scored from 0 to 5 (0 = no problem, 5 = problem as bad as it can be), with a total score ranging from 0 to 110. Higher scores indicate worse symptom severity and poorer quality of life.
Time frame: 6 months
Smell test
UPSIT is a questionnaire with 40 different smells
Time frame: 6 months