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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSt. Paul's Sinus Centre

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Budesonide

    Drug

    Participants will use Budesonide twice daily

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: BudesonideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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.

Time frame
6 months

Secondary outcomes

1

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
2

Smell test

UPSIT is a questionnaire with 40 different smells

Time frame
6 months

Other outcomes

Sponsors and contacts

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