Brensocatib for Chronic Sinusitis
(BiRCh Trial)
Recruiting in Palo Alto (17 mi)
+104 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Insmed Incorporated
Must be taking: MFNS
Disqualifiers: CRSwNP, Cystic fibrosis, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing brensocatib to see if it helps people with chronic sinus inflammation without nasal polyps. The goal is to see if it can reduce their symptoms by lowering sinus swelling.
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.
How is the drug Brensocatib different from other treatments for chronic sinusitis?
Brensocatib is unique because it targets a specific enzyme called DPP1 (dipeptidyl peptidase I), which is involved in the activation of neutrophil serine proteases, potentially reducing inflammation in chronic sinusitis. This mechanism is different from other treatments like steroids or antihistamines, which primarily focus on reducing symptoms rather than targeting the underlying inflammatory process.12345
Research Team
Eligibility Criteria
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.
See 5 more
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.
See 7 more
Trial Timeline
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
Treatment Details
Interventions
- Brensocatib (Anti-inflammatory)
Trial OverviewThe 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.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Brensocatib 40 mgExperimental Treatment2 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 mgExperimental Treatment2 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: PlaceboPlacebo Group2 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Insmed Incorporated
Lead Sponsor
Trials
44
Recruited
7,600+
Findings from Research
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]
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 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]
References
Intranasal Spray Characteristics for Best Drug Delivery in Patients With Chronic Rhinosinusitis. [2023]
Study on the effects of desloratadine citrate disodium on the postoperative complications and inflammatory response in patients with chronic sinusitis undergoing endoscopic sinus surgery. [2021]
Dupilumab for chronic rhinosinusitis with nasal polyps: real-life retrospective 12-month effectiveness data. [2023]
Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children. [2019]
Residual nasal polyp tissue following dupilumab therapy is associated with periostin-associated fibrosis. [2023]