Brensocatib for Chronic Sinusitis

(BiRCh Trial)

No longer recruiting at 117 trial locations

Overseen By Insmed Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Insmed Incorporated

Must be taking: MFNS

Disqualifiers: CRSwNP, Cystic fibrosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medicine called brensocatib to determine if it improves symptoms for people with chronic sinusitis without nasal polyps. The study compares two doses of brensocatib to a placebo (a pill with no active medicine). It seeks participants who have experienced sinus problems for at least 12 weeks and have tried treatments like surgery, steroids, or antibiotics in the past year. Participants should have a history of sinus inflammation confirmed by a CT scan and regularly use a nasal spray. The study aims to determine if brensocatib can alleviate daily sinus issues. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must have been on a stable dose of MFNS (a nasal spray) for at least 4 weeks before starting the trial.

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

Research has shown that brensocatib was safe in previous studies. Participants generally tolerated it well, with no major safety issues reported. Some experienced mild side effects like diarrhea or headaches, but these were manageable.

Researchers are studying this treatment for chronic sinusitis. Since studies have safely used it for other conditions, it might also be safe for this one. However, everyone is different, so discussing any concerns with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic sinusitis?

Most treatments for chronic sinusitis focus on reducing inflammation or treating infections with antibiotics. However, brensocatib works differently by targeting the enzyme neutrophil serine protease, which plays a key role in the inflammatory process. Unlike traditional treatments, brensocatib aims to address the underlying cause of excessive inflammation, potentially providing a more effective long-term solution. Researchers are excited about brensocatib because it could offer a new approach to managing chronic sinusitis, especially for patients who don't respond well to existing therapies. Additionally, the trial explores different dosages (10 mg and 40 mg), which could optimize treatment outcomes and minimize side effects.

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

Research shows that brensocatib may help with breathing problems. In earlier studies, brensocatib reduced lung flare-ups and delayed their return. This suggests that brensocatib helps with inflammation, a major issue in chronic sinusitis. Although limited data exists specifically for chronic sinusitis without nasal polyps (CRSsNP), the positive results in similar conditions are promising. In this trial, participants will receive either varying dosages of brensocatib or a placebo to determine its effectiveness in improving symptoms for people with chronic sinusitis. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for people with chronic sinusitis without nasal polyps who've had sinus surgery, steroid treatments, or antibiotics within the last year. They must have ongoing symptoms confirmed by endoscopy and CT scan, a blood eosinophil count ≤750 cells/μL, and a specific symptom score. Those with planned sinus surgery, certain skin conditions, cystic fibrosis, recent nasal surgery or fungal infections are excluded.

Inclusion Criteria

I have had significant nasal symptoms scoring 5 or more recently.

You have had sinus surgery, been treated with systemic corticosteroids, or taken antibiotics to treat sinus symptoms within the past year.

I have had sinus issues for at least 12 weeks and it was confirmed by a doctor using a special camera.

Exclusion Criteria

I am experiencing sudden symptoms similar to a severe sinus infection.

I have seasonal allergies that flare up during the study period.

I am scheduled for sinus surgery during the study period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brensocatib or placebo once daily for 24 weeks along with mometasone furoate nasal spray

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brensocatib

Trial Overview The study tests if brensocatib (10mg or 40mg daily) is better than a placebo at improving symptoms of chronic rhinosinusitis without nasal polyps. Participants will also use mometasone furoate nasal spray as part of their treatment regimen.

How Is the Trial Designed?

Group I: Brensocatib 40 mg Experimental Treatment 2 Interventions

Participants will receive brensocatib 40 mg tablet, orally, QD for 24 weeks along with mometasone furoate nasal spray (MFNS) by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.

Group II: Brensocatib 10 mg Experimental Treatment 2 Interventions

Participants will receive brensocatib 10 mg tablet, orally, QD for 24 weeks along with MFNS by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.

Group III: Placebo Placebo Group 2 Interventions

Participants will receive a brensocatib-matching placebo tablet, orally, QD for 24 weeks along with MFNS by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.

Who Is Running the Clinical Trial?

Insmed Incorporated

Lead Sponsor

Trials

44

Recruited

7,600+

Published Research Related to This Trial

In a study involving patients with chronic sinusitis undergoing endoscopic sinus surgery, the addition of desloratadine citrate disodium significantly improved the total effective rate of the surgery to 94.9%, compared to 82.2% in the control group.

Patients treated with desloratadine showed lower levels of inflammatory markers and a significantly reduced incidence of postoperative complications, indicating its efficacy in enhancing recovery and safety in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on the effects of desloratadine citrate disodium on the postoperative complications and inflammatory response in patients with chronic sinusitis undergoing endoscopic sinus surgery. Ma, M., Liu, L., Jin, W., et al.[2021]

Dupilumab is effective in treating uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP), showing significant improvements in nasal endoscopy scores and patient-reported outcomes over a 12-month follow-up in a study of 41 patients.

While dupilumab led to a decrease in total serum IgE levels and maintained improvements in symptoms, some patients experienced short- and long-term elevations in blood eosinophil counts, which should be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for chronic rhinosinusitis with nasal polyps: real-life retrospective 12-month effectiveness data. Boscke, R., Heidemann, M., Bruchhage, KL.[2023]

In a study of 52 children with acute maxillary sinusitis, those treated with intranasal budesonide alongside antibiotics showed a significantly higher recovery rate compared to those receiving oral pseudoephedrine and antibiotics.

The use of intranasal budesonide was found to be safe, with no adverse effects reported, suggesting it could be an effective adjunct treatment for acute sinusitis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children. Yilmaz, G., Varan, B., Yilmaz, T., et al.[2019]

The study used computational fluid dynamics to simulate intranasal drug delivery in patients with chronic rhinosinusitis, revealing that optimal particle sizes for effective deposition in the ostiomeatal complex (OMC) were between 6 and 10 μm, while larger particles (21 to 30 μm) also showed good results.

Maximal drug deposition in the OMC ranged from 0.78% to 12.44%, but achieving effective delivery to the maxillary sinus (MS) was more challenging, with deposition only reaching 0.02% to 1.03%, indicating that anatomical variations significantly affect drug delivery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal Spray Characteristics for Best Drug Delivery in Patients With Chronic Rhinosinusitis. Popper, C., Martin, H., Shah, R., et al.[2023]

In a study of 63 patients with refractory eosinophilic chronic rhinosinusitis (ECRS) treated with dupilumab for 24 weeks, significant improvements in sinonasal symptoms and a reduction in nasal polyp scores were observed, with 63.5% of patients experiencing resolution of nasal polyps.

Despite the overall effectiveness of dupilumab, some patients showed limited reduction in nasal polyps, which may be linked to increased periostin and collagen deposition in the remaining polyp tissues, suggesting a complex mechanism of action involving tissue fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Residual nasal polyp tissue following dupilumab therapy is associated with periostin-associated fibrosis. Suzaki, I., Maruyama, Y., Kamimura, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06013241

NCT06013241 | A Study of the Efficacy and Safety ... The primary purpose of the study is to evaluate the efficacy of brensocatib at 10 and 40 milligrams (mg) once daily (QD) compared with placebo in improving ...

2. investor.insmed.com investor.insmed.com/2025-05-21-Brensocatib-Shows-Consistent-Efficacy-and-Safety-Across-Three-Prespecified-Subgroups-in-New-Data-from-Landmark-ASPEN-Study

Brensocatib Shows Consistent Efficacy and Safety Across ... Three prespecified subgroup analyses from ASPEN showed brensocatib reduced pulmonary exacerbations, prolonged time to first exacerbation, and reduced lung ...

3. prnewswire.com prnewswire.com/news-releases/brensocatib-shows-consistent-efficacy-and-safety-across-three-prespecified-subgroups-in-new-data-from-landmark-aspen-study-302462008.html

Brensocatib Shows Consistent Efficacy and Safety Across ... Three prespecified subgroup analyses from ASPEN showed brensocatib reduced pulmonary exacerbations, prolonged time to first exacerbation, and reduced lung ...

4. withpower.com withpower.com/trial/phase-2-sinusitis-8-2023-f6529

Brensocatib for Chronic Sinusitis (BiRCh Trial) Dupilumab is effective in treating uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP), showing significant improvements in nasal endoscopy scores ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-brensocatib-for-patients-with-chronic-rhinosinusitis-without-nasal-polyps/

Study on the Effectiveness and Safety of Brensocatib ... This study investigates the safety and effectiveness of Brensocatib in treating Chronic Rhinosinusitis without Nasal Polyps, comparing it ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2025/217673Orig1s000IntegratedR.pdf

217673Orig1s000 INTEGRATED REVIEW - accessdata.fda.gov 24 weeks in Study 201), and brensocatib is intended for chronic use. Results from Study 301 demonstrated a statistically significant ...