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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 weeks
Awards & highlights

BiRCh Trial Summary

This trial is testing a new drug to see if it can help relieve symptoms of chronic rhinosinusitis with nasal polyps.

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.Check my eligibility
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.See study design
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.

BiRCh Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had significant nasal symptoms scoring 5 or more recently.
Select...
My CT scan shows inflammation in both sides of my sinuses.

BiRCh Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline to the 28-day Average of Daily Sinus Total Symptom Score (sTSS) at Week 24
Secondary outcome measures
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

BiRCh 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

Find a Location

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
6,932 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for this clinical investigation limited to below 45 years?

"Elderly applicants who have attained the age of consent are welcome to participate in this trial. The upper limit for patient's ages is 75 years old."

Answered by AI

To what extent is enrollment being increased for this research project?

"The trial requires 270 compliant candidates to take part. USA019 in Hollywood, Florida and USA001 Miami, Indiana are two of the available sites where patients can join this experiment."

Answered by AI

How may I register for this clinical trial?

"This clinical trial requires prospective participants to have chronic sinusitis and be within the ages of 18-75. Additionally, a total of 270 patients will be accepted into this study."

Answered by AI

How many locales are engaged in administering this medical experiment?

"This clinical trial can be accessed across 4 different sites, including Hollywood's USA019, Miami's USA001 and New Albany's USA003. Additionally, there are other medical centres participants may visit for enrolment into the study."

Answered by AI

Is this clinical experiment currently recruiting participants?

"According to the records found on clinicaltrials.gov, this medical trial is presently open for recruitment. The initial listing was submitted November 3rd 2023 and has been revised as recently as October 13th of that same year."

Answered by AI

Has Brensocatib 40 mg received regulatory clearance from the FDA?

"Given the Phase 2 status of this trial, our team at Power has assigned Brensocatib 40 mg a safety rating of 2 due to some existing evidence backing its security but none validating effectiveness."

Answered by AI

Who else is applying?

What site did they apply to?
USA006
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
2023. "A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06013241.
~180 spots leftby Aug 2025
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