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CRSwNP3 AxisNCT07528820

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

A study testing Budesonide in people with CRSwNP and Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis, run by St. Paul's Sinus Centre at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 19 years and older
What is being tested?
Budesonide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
1 Jul 2026to 1 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 24Show fewer
  • 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
  • Proven severe infection requiring outpatient treatment with parenteral (IV or IM) antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60 days of Day 1. Prophylactic anti-infective treatment is allowed.
  • Known positive human immunodeficiency virus (HIV)** status
  • Known positive Hepatitis B (HB) or Hepatitis C* status
  • Having clinical evidence of significant unstable or uncontrolled acute or chronic diseases, in the opinion of the principal investigator, could confound the results of the study or put the participant at undue risk
  • Have a planned surgical procedure, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the participant unsuitable for the study.
  • Have received any investigational agent (that is not approved for sale in Canada) within 60 days of Day 1(Baseline visit)
  • Smoking history; current or former smokers with a smoke history of packs year >15
  • Subjects with parasitic (helminthic) infection Note: If there is any interested patient who is pregnant, breast-feeding or planning to get pregnant during the study period, and is interested in participation, the principal investigator will share the potential risks with them, as the drug crosses the placenta and is present in breast milk, before they decide to enroll in this study.
  • As these infectious diseases induce significant and distinct changes to the immune system and inflammatory profile.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrew Thamboo, MD contact

604-806-9926

andrew.thamboo@gmail.com

Canada1 site

  • St Paul's Sinus Centre

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: Investigating Sinonasal Inflammatory Profiles, Histopathological Features, and Remodeling Factors in Chronic Rhinosinusitis Patients With Nasal Polyposis

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

Read the detailed description

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.

Being tested
Budesonide
Keywords
CRS, CRSwNP
Medical subject headings
Disease, Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BudesonideDrug

    Also called (Pulmicort)

    Participants will use Budesonide twice daily

Study groups in NCT07528820
Study groupRoleWhat they receive
BudesonideExperimentalParticipants will use budesonide for 6 months to treat CRSwNP
Receives: Drug: Budesonide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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.

    Measured: 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.

    Measured: 6 months

Secondary outcomes (2)

  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.

    Measured: 6 months

  2. Smell test

    UPSIT is a questionnaire with 40 different smells

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07528820
Sponsor's protocol ID
H25-00257
Acronym
3 Axis
Status last verified
Apr 2026
First submitted
13 Dec 2025
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We're undecided

Questions about this trial

What is this clinical trial studying?

A study testing Budesonide in people with CRSwNP and Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis, run by St. Paul's Sinus Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrew Thamboo, MD (604-806-9926, andrew.thamboo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in sinonasal inflammatory cytokine concentrations measured in nasal secretions using multiplex immunoassay (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07528820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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