Budesonide for Sinusitis

(3 Axis Trial)

Overseen By Andrew Thamboo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Paul's Sinus Centre

Must not be taking: Antihistamines, Corticosteroids, Biologics, others

Disqualifiers: Organ transplant, Autoimmune diseases, Tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Andrew Thamboo, MD

Principal Investigator

St. Paul's Sinus Centre

Are You a Good Fit for This Trial?

Inclusion Criteria

I have chronic sinusitis with nasal polyps and a nasal polyp score of at least 2 on each side.

I am not planning to have surgery in the next 7 months.

I am able to understand and sign a consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will use budesonide for 6 months to treat CRSwNP

6 months

Regular visits for treatment monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Budesonide

How Is the Trial Designed?

Group I: Budesonide Experimental Treatment 1 Intervention

Participants will use budesonide for 6 months to treat CRSwNP

Who Is Running the Clinical Trial?

St. Paul's Sinus Centre

Lead Sponsor

Trials

4

Recruited

170+