Inflammatory Profiles, Histopathological Features, and Remodeling Factors in Chronic Rhinosinusitis With Nasal Polyps

NCT07528820 | Not Yet Recruiting

• 1 other identifier: H25-00257
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine three key aspects of chronic rhinosinusitis with nasal polyps (CRSwNP): inflammation, tissue structure (histopathology), and remodeling.

Conditions

CRSwNP; Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis

Keywords

CRS; CRSwNP

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  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.

  6 months

Secondary Outcomes (2)

• SNOT-22

  6 months

• Smell test

  6 months

Study Arms (1)

Budesonide

EXPERIMENTAL

Participants will use budesonide for 6 months to treat CRSwNP

Drug: Budesonide

Interventions

Budesonide DRUG

Participants will use Budesonide twice daily

Also known as: (Pulmicort)

Budesonide

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Autoimmune medications such as: a) Systemic Steroids, b) Disease-modifying antirheumatic drugs (DMARDs) (non-biologic); c) Biologics such as anti-TNF, anti-IL, anti-B cell, anti-T cell; and d) Small molecules.
• A history of auto-immune diseases such as Rheumatoid arthritis and Systemic lupus erythematosus,
• Current or past sinonasal or bronchial tumors
• Currently using systemic or oral corticosteroids (such as Prednisone, Methylprednisolone)
• Current participation in any interventional treatment trials
• Diagnosed or suspected malignant or premalignant nasal disease (e.g. Schniderian Papilloma, unilateral nasal polyposis)
• Fungal rhinosinusitis (CT/Histology), positive Aspergillus skin prick testing and/or positive Aspergillus IgE RAST (Radioallergosorbent) testing
• Malignant neoplasm within 5 years (from screening) excluding basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterinecervix treated locally and without metastatic disease for 3 years.
• Active bleeding disorders, and/or inability to support interruption to anticoagulant or anti-platelet therapies for nasal biopsy.
• Severe nasal deformity precluding endoscopic assessment/biopsy of postnasal space
• Have an acute or chronic infection (excluding that related to CRS) requiring management as follows:
• Currently on any treatment for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria
• Hospitalization solely for the treatment of proven infection requiring parenteral (IV or IM) antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60 days of Day 1

Sponsors & Collaborators

• St. Paul's Sinus Centre: lead

Study Sites (1)

St Paul's Sinus Centre

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Disease; Nasal Polyps

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Andrew Thamboo, MD

  St. Paul's Sinus Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Thamboo, MD

CONTACT

604-806-9926; andrew.thamboo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: April 14, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CA (1)