About this trial
This study aims to examine three key aspects of chronic rhinosinusitis with nasal polyps (CRSwNP): inflammation, tissue structure (histopathology), and remodeling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be ≥19 of age at the time of signing the informed consent form
Capable of giving signed informed consent.
Having CRSwNP based on clinical symptoms and/or radiographic or endoscopic evidence of inflammation in their upper airways (Diagnosis consistent with EPOS 2020)2 and nasal polyp score (NPS) of at least 2 on each side
Not expecting to have surgery within the next 7 months
Disqualifiers
A history of organ transplantation such as lung transplantation
Previously or currently using immunomodulator or allergy medications or (including The allergy medications such as: a) First and second generations of Antihistamines (H1 blockers); b) Oral/Topical Decongestants; c) Oral or systemic corticosteroids; d) Leukotriene Receptor Antagonists; e) Mast Cell Stabilizers.
A history of auto-immune diseases such as Rheumatoid arthritis and Systemic lupus erythematosus,
Current or past sinonasal or bronchial tumors
Trial design
Single group
Treatments tested in this trial
Budesonide
DrugParticipants will use Budesonide twice daily
Treatment groups
Trial outcomes
Primary outcomes
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)
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.
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.
Secondary outcomes
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.
Smell test
UPSIT is a questionnaire with 40 different smells
Sponsors and contacts
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