Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effectiveness and Safety of Brensocatib for Patients with Chronic Rhinosinusitis Without Nasal Polyps

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Featured sites

Sites that work closely with us on this trial

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Brensocatib on individuals with Chronic Rhinosinusitis without Nasal Polyps (CRSsNP). Chronic Rhinosinusitis is a condition where the sinuses become inflamed for a long period, leading to symptoms like nasal congestion and discomfort. The study will compare the effectiveness of Brensocatib, taken as a film-coated tablet, at doses of 10 mg and 40 mg, with a placebo. Another medication, Mometasone, which is a nasal spray, is also involved in the study.

The purpose of the study is to evaluate how well Brensocatib can improve nasal symptoms in participants with CRSsNP. Participants will be randomly assigned to receive either Brensocatib or a placebo, and the study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The study will last for 24 weeks, during which participants will take the medication daily and have regular check-ups to monitor their symptoms and overall health.

Throughout the study, various assessments will be conducted to measure changes in nasal symptoms, such as the Sinus Total Symptom Score and Nasal Congestion Scores. Additionally, the study will monitor any adverse events, changes in clinical laboratory test results, and other health indicators. The goal is to determine if Brensocatib is a safe and effective treatment option for improving the quality of life for those suffering from CRSsNP.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your medical history will be reviewed, and you will undergo a physical examination. Blood samples will be taken to measure your blood eosinophil count, which is a type of white blood cell.

    You will be asked about your symptoms of chronic rhinosinusitis without nasal polyps, including nasal congestion. This information will help establish a baseline for your symptoms.

  2. Step 2

    Randomization and medication

    You will be randomly assigned to receive either the study medication, brensocatib, or a placebo. A placebo looks like the study medication but does not contain the active ingredient.

    If you receive brensocatib, you will take it in the form of a film-coated tablet. The dosage will be either 10 mg or 40 mg, taken once daily by mouth.

  3. Step 3

    Treatment period

    The treatment period will last for 24 weeks. During this time, you will continue taking your assigned medication daily.

    You will be required to keep a daily record of your nasal symptoms, including congestion, using a symptom score system. This will help track any changes in your symptoms over time.

  4. Step 4

    Follow-up visits

    Throughout the 24-week treatment period, you will attend regular follow-up visits. These visits will include assessments of your symptoms, blood tests, and possibly imaging tests to evaluate changes in your sinus condition.

    Your overall health will be monitored, including vital signs and heart function through electrocardiograms (ECGs).

  5. Step 5

    End of treatment evaluation

    At the end of the 24-week period, you will have a final evaluation. This will include a comprehensive review of your symptoms and any changes observed during the study.

    The study team will also assess any side effects or adverse events you may have experienced while taking the medication.

Who can join the trial?

6 criteria

  • Must be a male or female aged between 18 and 75 years old.
  • Must have had Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) for at least 12 weeks.
  • Must currently have symptoms of nasal congestion.
  • Must have a blood eosinophil count of 750 cells/µL or less at the screening.
    (Eosinophils are a type of white blood cell involved in allergic reactions and fighting certain infections.)
  • Must have had sinonasal surgery for CRS or treatment with systemic corticosteroids (SCS) or antibiotics for CRS within a year before the screening visit.
    (Sinonasal surgery is an operation on the sinuses and nasal passages. Systemic corticosteroids are medications that reduce inflammation.)
  • Must have been on a stable daily dose of mometasone furoate nasal spray (MFNS) for at least 4 weeks before randomization.
    (Mometasone furoate nasal spray is a medication used to treat nasal symptoms.)

Who cannot join the trial?

10 criteria

  • Patients with any other significant health condition that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
  • Patients who have a history of non-compliance with medical treatments.
  • Patients who have a condition that requires treatment with medications that might interfere with the study drug.
  • Patients who have a history of severe allergic reactions.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Brensocatib is a medication being studied for its potential to help people with chronic rhinosinusitis, a condition where the sinuses are inflamed for a long time, causing symptoms like a stuffy or runny nose. This medication works by reducing inflammation, which might help improve nasal symptoms and make breathing easier for people with this condition. The study is looking at how effective and safe this medication is for people who do not have nasal polyps, which are growths in the nasal passages that can also cause breathing problems.

What is already known about the treatment

Brensocatib – Brensocatib is administered orally in the form of tablets, taken once daily. It is currently being studied in clinical trials for its effectiveness in treating chronic rhinosinusitis without nasal polyps, a condition characterized by long-term inflammation of the sinuses. The medication works by inhibiting certain enzymes that contribute to inflammation, thereby reducing symptoms like nasal congestion and discomfort. Brensocatib is classified as an anti-inflammatory agent, and its ongoing research aims to establish its safety and efficacy for this specific condition.

Investigated diseases

Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) – This condition is characterized by inflammation of the sinuses and nasal passages lasting for at least 12 weeks. It does not involve the presence of nasal polyps, which are noncancerous growths in the lining of the nasal passage or sinuses. Symptoms often include nasal congestion, facial pain or pressure, and a reduced sense of smell. The inflammation leads to swelling and blockage of the sinus openings, causing mucus to build up. This can result in discomfort and difficulty breathing through the nose. Over time, the persistent inflammation can lead to further complications, such as sinus infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502481-24-00Protocol codeThe BiRCh StudyEstimated enrolment337 patientsSponsorInsmed Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.