What side effects are associated with this type of intervention?

Common treatments for chronic sinusitis, including DPP1 inhibitors like Brensocatib, often have side effects such as headache, nasopharyngitis, and gastrointestinal issues. Biologics, such as dupilumab, can cause injection-site reactions, nasopharyngitis, worsening of nasal polyps, asthma, headache, and epistaxis. Corticosteroids, another common treatment, may lead to side effects like increased intraocular pressure, cataracts, and potential systemic effects with long-term use.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for treatments similar to Brensocatib (a DPP1 inhibitor) for Chronic Sinusitis in the provided context. However, treatments for chronic rhinosinusitis often include topical and systemic antifungal therapies, corticosteroids, and other anti-inflammatory agents. Brensocatib is being studied for its efficacy in improving clinical symptoms of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP).

What other types of research exist?

Promising novel alternatives to Brensocatib for Chronic Sinusitis patients may include other anti-inflammatory or immunomodulatory treatments. These could involve biologics targeting specific inflammatory pathways, such as monoclonal antibodies against cytokines or other immune modulators. Consulting with a healthcare provider for the latest clinical trial data and personalized treatment options is recommended.

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Anti-inflammatory

Brensocatib for Chronic Sinusitis (BiRCh Trial)

Verified Trial

Phase 2

Recruiting

Research Sponsored by Insmed Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have sTSS (nasal congestion [NC], anterior/posterior rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (Screening) and at Visit 2 (Baseline) (average score in the week prior to randomization)

Participants who have bilateral inflammation of paranasal sinuses in the CT scan performed during Screening and bilateral ethmoid and/or maxillary opacification before randomization as confirmed by the central reader

Must not have

Diagnosis of unilateral or bilateral chronic rhinosinusitis with nasal polyps (CRSwNP)

Clinical diagnosis of cystic fibrosis (CF) or primary ciliary dyskinesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects may include headache, nausea, diarrhea or constipation related to brensocatib; nosebleeds and headaches from mometasone furoate nasal spray; plus potential placebo effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My CT scan shows inflammation in both sides of my sinuses.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with chronic sinusitis with nasal polyps.

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I have been diagnosed with cystic fibrosis or primary ciliary dyskinesia.

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I am scheduled for sinus surgery during the study period.

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I have not had nasal surgery in the last 4 weeks.

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I have major issues with the structure of my mouth or severe nasal passage blockage.

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I may have a fungal infection or tumor in my nose or sinuses.

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

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I need strong medication for my severe skin condition.

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I have been diagnosed with Papillon-Lefèvre syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline to the 28-day Average of Daily Sinus Total Symptom Score (sTSS) at Week 24

Secondary study objectives

Change From Baseline in Modified Lund-MacKay (LMK) Computed Tomography (CT) Score at Week 24

Change From Baseline in Percentage of Sinus (Maxillary and Ethmoid) Opacification as Measured by Volumetry at Week 24

Change From Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24

+5 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brensocatib

2023

Completed Phase 3

~620

Mometasone furoate nasal spray (MFNS)

2008

Completed Phase 3

~1770

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Sinusitis include corticosteroids, antibiotics, saline nasal irrigation, and mucolytics. Corticosteroids reduce inflammation by inhibiting multiple inflammatory pathways, while antibiotics target bacterial infections that may exacerbate sinusitis. Saline nasal irrigation helps clear mucus and allergens from the nasal passages, and mucolytics thin mucus to facilitate its clearance. Brensocatib, a DPP1 inhibitor, works by reducing the activation of neutrophil serine proteases, which are enzymes that contribute to inflammation and tissue damage in the sinuses. This mechanism is particularly important for Chronic Sinusitis patients as it directly targets the inflammatory processes that underlie the condition, potentially offering a more targeted and effective treatment option.

Developing a core outcome set for chronic rhinosinusitis: a systematic review of outcomes utilised in the current literature.Topical therapies in the management of chronic rhinosinusitis: an evidence-based review with recommendations.