Nebulized Budesonide for Chronic Sinusitis

Overseen By Sara Kukuljan

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Washington University School of Medicine

Must not be taking: Biologics, Oral corticosteroids

Disqualifiers: Sinus surgery, Severe polyposis, 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: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well the medication budesonide works for individuals with chronic sinusitis, a long-lasting inflammation of the sinuses. It compares two methods of administering budesonide: a nasal rinse and a nebulizer, which turns liquid medicine into a mist. The trial aims to determine which method is safer, more effective, and more comfortable for patients. Eligible participants should have experienced chronic sinusitis symptoms, such as nasal blockage or facial pain, for over 12 weeks, confirmed by a doctor. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking oral corticosteroids or have taken oral antibiotics within 2 weeks before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that budesonide is generally safe for short-term use in treating nasal issues. Studies have found that patients using budesonide with a nebulizer experienced better nasal symptoms without major side effects. One study found that reducing the dose by half did not worsen symptoms, suggesting the treatment is well-tolerated.

Budesonide is already approved for other uses, providing a known safety record. While this trial tests it for chronic sinusitis, its existing approval offers some confidence in its safety. Reports of serious side effects from using budesonide in these situations are absent, which is encouraging for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for chronic sinusitis, which often include oral corticosteroids or antibiotics, budesonide in this trial is being used in two innovative ways. First, the budesonide is delivered directly to the nasal passages using a saline lavage, potentially enhancing its effectiveness by ensuring the medication reaches the affected areas more thoroughly. Second, the nebulizer group skips the saline lavage, offering a simpler administration method that could be more convenient for patients. Researchers are excited about these methods because they could offer more targeted relief with fewer systemic side effects compared to traditional oral medications.

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

Research has shown that nebulized budesonide can help treat chronic rhinosinusitis (CRS) by easing nasal symptoms and shrinking polyps. In this trial, participants in the nebulizer group will use nebulized budesonide, which studies have found to be as effective as budesonide irrigation. Participants in the budesonide lavage group will use budesonide with saline in a nasal rinse, which has improved CRS symptoms more than saline alone. Both treatments show promise in helping patients with CRS feel better. ^{6 7 8 9 10}

Who Is on the Research Team?

Nyssa Farrell, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with chronic sinusitis, a persistent inflammation of the sinuses. Specific eligibility criteria are not provided, but typically participants would need to have a confirmed diagnosis and be in stable health.

Inclusion Criteria

I have had symptoms like nasal blockage and facial pain for over 12 weeks, confirmed by a CT scan or nasal endoscopy.

I am 18 or older and have been diagnosed with CRS, with or without nasal polyps.

Exclusion Criteria

I have had sinus surgery before.

Severe polyposis defined as Lund Kennedy endoscopy score greater than 1

I have used biologic medications for my nasal polyps.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either nebulized budesonide via the NasoNeb or budesonide lavage for 42 days

6 weeks

1 visit (in-person) for enrollment and instruction

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments like SNOT-22 and Lund-Kennedy scores

6 weeks

2 visits (in-person) for assessments at week 3 and week 6

What Are the Treatments Tested in This Trial?

Interventions

• Budesonide

Trial Overview The study is testing the effectiveness and safety of budesonide, an anti-inflammatory steroid, delivered through two methods: nebulization using NasoNeb and lavage using NeilMed. It's a randomized controlled trial which means patients are randomly assigned to one of these treatments.

How Is the Trial Designed?

Group I: nebulizer group Experimental Treatment 1 Intervention

Subjects in the nebulizer group will be prescribed a 42-day supply of 0.5 mg budesonide packets, to be used twice daily without any concomitant saline lavage.

Group II: budesonide lavage group Active Control 1 Intervention

Subjects in the budesonide lavage group will be prescribed 42-day supply of 0.5 mg budesonide packets to be administered via 240 mL twice daily nasal saline lavage.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39729039/

Budesonide nasal irrigation for chronic rhinosinusitis Results: Twenty-six studies were reviewed, comprising 1464 patients. BNI had better outcomes than saline nasal irrigation (SNI) regarding Sino- ...

2. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2683622

Effect of Budesonide Added to Saline Sinus Irrigation for ... Recent studies suggest that budesonide added to saline nasal lavage can be an effective treatment for patients with chronic rhinosinusitis (CRS) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02696850

The Impact Of The Addition Of Budesonide To Low ... The goal of this research project is to explore the impact of the addition of budesonide to high-volume, low-pressure nasal sinus saline irrigation.

4. rhinologyjournal.com rhinologyjournal.com/Rhinology_issues/manuscript_3249.pdf

Budesonide nasal irrigation for chronic rhinosinusitis Outcomes of budesonide nasal irrigation (BNI) versus saline nasal irrigation (SNI) n=1464. 26 studies reviewed. BNI > SNI in SNOT-22 ...

5. journals.lww.com journals.lww.com/apallergy/fulltext/2023/12000/application_of_nasal_irrigation_in_the_treatment.7.aspx

Application of nasal irrigation in the treatment of chronic .. ... Tolerability and effectiveness of povidone-iodine or mupirocin versus saline sinus irrigations for chronic rhinosinusitis. Am J Otolaryngol ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12245255/

Nasal nebulization inhalation of budesonide for chronic ... This study will assess the efficacy and safety of NNIB for the treatment of CRNP through assessing primary outcomes of nasal symptoms and polyp sizes.

7. jacionline.org jacionline.org/article/s0091-6749(14)01513-9/fulltext

Effect of budesonide transnasal nebulization in patients ... Overall, our study indicated that budesonide transnasal nebulization led to significant improvements in all the major nasal symptoms and reduced the size of NPs ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07270302

Study Details | NCT07270302 | Nebulized Nasal Steroids The goal of the proposed project is to assess the efficacy, safety, and patient experience of budesonide administered via the NasoNeb system ...

9. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/409962

The Effect of Nasally Administered Budesonide Respules ... The clinical significance of this study is that budesonide nasal respules appear safe for short-term use for the relief of symptoms associated with chronic ...

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/alr.23336

Double blind randomized controlled trial measuring the ... Of clinical significance, patients who received budesonide at half the dose via nebulizer did not have worsened symptom scores or deterioration ...