Budesonide for Sinusitis

(3 Axis Trial)

AT
Overseen ByAndrew Thamboo, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests budesonide, a medication, to evaluate its effectiveness in treating chronic rhinosinusitis with nasal polyps (CRSwNP). Researchers aim to understand how the medication affects inflammation, tissue structure, and changes in the sinuses. Participants should have CRSwNP with noticeable symptoms and no plans for surgery in the next seven months. This trial helps experts learn more about how budesonide works for individuals with this condition. As an unphased trial, it offers participants a unique opportunity to contribute to scientific understanding and potentially benefit from new insights into their condition.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes participants who are currently using immunomodulator or allergy medications, including antihistamines, decongestants, corticosteroids, and others. If you are on these medications, you would need to stop them to participate in the trial.

Is there any evidence suggesting that budesonide is likely to be safe for humans?

Research has shown that budesonide is generally safe and well-tolerated for treating chronic rhinosinusitis with nasal polyps (CRSwNP). Several studies have identified budesonide as a safe choice for patients. For example, one study demonstrated that using budesonide as a nasal spray, along with other treatments, was effective and safe for adults. Another study found that delivering budesonide to the sinuses with a misting device was safe for short-term use. Additionally, budesonide nasal drops significantly reduced nasal symptoms without major safety concerns.

These studies suggest that budesonide is a safe treatment for CRSwNP, with only minor side effects reported in some cases. This makes it a promising option for those considering joining a trial.12345

Why are researchers excited about this trial?

Budesonide is unique because it offers a targeted approach for treating chronic rhinosinusitis with nasal polyps (CRSwNP). Unlike standard treatments like saline rinses, antihistamines, or oral corticosteroids, budesonide is a corticosteroid administered directly to the nasal passages, allowing for localized action with potentially fewer side effects. Researchers are excited about this treatment because it could effectively reduce inflammation and polyp size directly at the source, offering relief without the systemic impacts often associated with oral steroids.

What evidence suggests that budesonide might be an effective treatment for sinusitis?

Research has shown that budesonide effectively treats chronic sinus inflammation with nasal polyps (CRSwNP). In this trial, participants will use budesonide for 6 months to treat CRSwNP. Studies indicate that using budesonide in a nasal rinse can help manage symptoms, especially for those unable to undergo sinus surgery. Patients using budesonide have reported significant improvements in stuffy nose, mucus in the throat, and loss of smell. Long-term use has lessened symptoms and improved sinus health. Overall, these findings suggest that budesonide could be a helpful option for managing CRSwNP symptoms.12367

Who Is on the Research Team?

AT

Andrew Thamboo, MD

Principal Investigator

St. Paul's Sinus Centre

Are You a Good Fit for This Trial?

This trial is for adults aged 19 or older who have chronic rhinosinusitis with nasal polyps, confirmed by symptoms and tests, and a certain level of polyp severity. Participants should not need sinus surgery in the next 7 months and must be able to give consent.

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.
See 1 more

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

Trial Overview

The study is testing budesonide (a steroid nasal spray) in people with chronic rhinosinusitis with nasal polyps to better understand inflammation, tissue changes, and healing processes related to this condition.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: BudesonideExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Paul's Sinus Centre

Lead Sponsor

Trials
4
Recruited
170+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41686524/

Effect of Budesonide Nasal Irrigation in Patients With ...

Conclusion: Budesonide nasal irrigation may be an important tool for controlling sinonasal symptoms in patients with CRSwNP who are not ...

Effect of Budesonide Nasal Irrigation in Patients With ...

Budesonide nasal irrigation may be an important tool for controlling sinonasal symptoms in patients with CRSwNP who are not candidates for sinus ...

Efficacy and safety of intranasal corticosteroids combined ...

While, the budesonide-ELP patients had a higher improvement percentage in nasal congestion, postnasal drip, rhinorrhea, and anosmia at week 8 (all P < 0.05).

The Long-Term Effects of Budesonide Nasal Irrigation in ...

Therefore, BNI is considered an effective treatment method that can improve subjective symptoms and objective intranasal findings while reducing ...

Long-term Use of Budesonide Nasal Irrigation Effective for ...

Patients with comorbid chronic rhinosinusitis (CRS) with nasal polyps and asthma reported significant reductions in endoscopic sinus score and severity.

Chronic rhinosinusitis with nasal polyposis: Management ...

One small, randomized trial compared 12 weeks of budesonide irrigations (0.5 mg daily) with budesonide nasal spray (512 mcg daily), each with ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24449682/

The safety and efficacy of short-term budesonide delivered ...

The MAD is likely a safe and effective method of delivering budesonide to the sinuses in the short term.