Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Participants with Chronic Rhinosinusitis Without Nasal Polyps – The BiRCh Study

This important study, called the BiRCh Study, is testing a new tablet medicine called brensocatib for adults who suffer from chronic rhinosinusitis without nasal polyps. This is a long-term condition causing inflammation in the nose and sinuses, often leading to symptoms like a stuffy or runny nose, facial pain, and a reduced sense of smell. Researchers want to find out if brensocatib is effective at reducing these symptoms and if it is safe to use. Some participants will receive the new medicine, while others will get a 'dummy' pill (placebo) that looks exactly the same, plus a standard nasal spray. This approach helps us understand the medicine's true effects. The study will look at how much people's symptoms improve over 24 weeks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Insmed Inc.

Enrolment target

203

Start

06 Feb 2024

Chronic Rhinosinusitis without Nasal Polyps (CRSsNP)

What is this study about?

This study is investigating a new medicine called brensocatib for a common and often bothersome condition called chronic rhinosinusitis without nasal polyps. This is a long-lasting inflammation of the nose and sinus lining, which can cause symptoms like a blocked or runny nose, pressure or pain in the face, and a reduced sense of smell. It's different from sinus problems where polyps (non-cancerous growths) are present.

The main goal of this study is to see if brensocatib can help reduce these symptoms and improve how people feel, compared to taking a placebo (a tablet with no active medicine). The researchers will also be checking if the medicine is safe and if it causes any unwanted side effects. The study is called 'Phase 2b', which means it's one of the earlier steps in testing a new medicine, focusing on finding the right dose and gathering more information about its effectiveness and safety.

Finding better treatments for chronic rhinosinusitis without nasal polyps is important because the condition can significantly affect daily life and comfort. If brensocatib proves to be effective and safe, it could offer a new option for people struggling with these persistent sinus issues. Participants will receive either brensocatib or a placebo, along with a standard nasal spray (mometasone), and their symptoms will be closely monitored over 24 weeks.

Key takeaways

This study is testing a new tablet for long-term sinus problems without nasal polyps.
It aims to see if the new medicine, brensocatib, improves symptoms and is safe.
Participants will receive either brensocatib or a dummy pill.
The study involves regular visits, assessments, and tracking daily symptoms.
It lasts for about 24 weeks and is for adults aged 18 and over.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old. Both men and women are welcome to take part.

The study is specifically for people who have been diagnosed with chronic rhinosinusitis and do NOT have nasal polyps. If you have had your sinus problems for a short time, or if you have polyps, this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have long-term sinus problems that have been diagnosed by a doctor?
Have you been told you do NOT have nasal polyps?
Are you willing to attend regular clinic visits for 24 weeks?
Are you willing to take a study tablet daily and use a nasal spray?
Are you comfortable with blood tests, scans, and questionnaires?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for a total of 24 weeks. Throughout this time, you would take either the brensocatib tablet or a dummy pill (placebo), along with a standard nasal spray. You wouldn't know which tablet you're receiving, and neither would your study doctor, to ensure the results are as fair as possible.

You would have several visits to the study clinic where the medical team would check your general health, conduct exams, and collect blood and urine samples. They would also perform scans of your sinuses and ask you to complete questionnaires about your symptoms and how you are feeling. You would also track your daily symptoms using a special diary or app. There would be assessments of your breathing through your nose. All these checks help the researchers understand if the medicine is working and if it is safe for you.

Potential risks and benefits

Participating in a study like this could potentially offer benefits, such as receiving a new medicine that might improve your chronic sinus symptoms, and having your condition closely monitored by medical experts. However, there's no guarantee the new medicine will work for you, and you might receive the placebo. All medicines can have side effects, and while the study aims to find if brensocatib is safe, there could be unknown risks. You might also experience discomfort from clinic visits, blood tests, or scans. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Bulgaria
—
Unverified
Czechia
—
Unverified
Denmark
—
Unverified
Spain
—
Unverified
Portugal
—
Unverified
Belgium
—
Unverified
France
—
Unverified
Poland
—
Unverified
Germany
—
Unverified
Italy
—
Unverified
Hungary

Common questions

What is chronic rhinosinusitis without nasal polyps?

It's a long-lasting inflammation of your nose and sinuses that causes symptoms like a stuffy or runny nose, facial pressure, and loss of smell, but without any growths (polyps) inside your nose.

What is brensocatib?

It's a new tablet medicine being tested to see if it can help reduce the symptoms of chronic rhinosinusitis without nasal polyps.

What is a 'placebo'?

A placebo is a 'dummy' tablet that looks exactly like the actual medicine but contains no active drug. It helps researchers understand if the medicine itself is causing the effects.

How long does the study last?

If you join the study, you would be involved for a total of 24 weeks, which is about 5 and a half months.

Will I know if I'm getting the real medicine or the placebo?

No, during the study, neither you nor your study doctor will know whether you are receiving brensocatib or the placebo. This is called 'double-blind' and helps ensure the results are unbiased.