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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Nemocnice Pardubickeho kraje a.s.	Pardubice	Czechia
IRCCS Humanitas Research Hospital	Rozzano	Italy
University Hospital Jena KöR	Jena	Germany
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Alergologia Plus Sp. z o.o.	Poznan	Poland
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Eb Group Sp. z o.o.	Warsaw	Poland
Centrum Medyczne Oporow	Wroclaw	Poland
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Pneumocare	Namur	Belgium
MBAL Trakia EOOD	Stara Zagora	Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Universita’ Di Pisa	Pisa	Italy
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)	Aveiro	Portugal
Rigshospitalet	Copenhagen	Denmark
University Of Pecs	Pecs	Hungary
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Fakultni Thomayerova nemocnice	Prague	Czechia
Region Sjaelland	Holbæk	Denmark
Cfszjyvoy Uauictqngjltnz Smpizbmog	Woluwe-Saint-Lambert	Belgium
Hoqvqmkg Uegohbszvfqzp Mjufzqe Df Vjaexhinau	Santander	Spain
Zonkwfu fgw Rtolttkxny uuz Aptkqytsoinv &dcptlb Gmfgtft	Wiesbaden	Germany
Cebhcas Mihalquy Boserjjo	Wieliczka	Poland
Oupjsnup Pveyo Nuqitzif Ojraikr	Olomouc	Czechia
Hebbcpcb Hbhmsnic	Hillerød	Denmark
Ppuzyrtbywh Ezeovvrdojww	Wroclaw	Poland
Aigogwuvtj Petxloef Hzyrsshp Di Mijcqteeq	Marseille	France
Amzeinl Oqvbsctevai Uhqonjgkhbpdo Sgawjq	Siena	Italy
Avyrbh Utqessotat Hlpqczdk	Aarhus	Denmark
Pydlhkl Szh z olub	Katowice	Poland
Mqhijnac Mdcluik Awwnzih	Pleven	Bulgaria
Fijmtlid ffi Hccppebqpbfhbgcaojnvzttoup Amlalpuhkkwz ahmhtwhzg uh suymkttzbz Oehzwldxiys	Mittweida	Germany
Hnyyxswq Uofusbgvtvdvyt Sskdyizomy &tekauu Hoppcnm dh Hozleovzqgk	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.11.2023
Bulgaria	Not recruiting	30.11.2023
Czechia	Not recruiting	30.11.2023
Denmark	Not recruiting	30.11.2023
France	Not recruiting	30.11.2023
Germany	Not recruiting	30.11.2023
Hungary	Not recruiting	30.11.2023
Italy	Not recruiting	30.11.2023
Poland	Not recruiting	30.11.2023
Portugal	Not recruiting	30.11.2023
Spain	Not recruiting	30.11.2023

Trial locations

Investigated drugs:

BRENSOCATIB

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.

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 ID:

2022-502481-24-00

Protocol code:

The BiRCh Study

NCT ID:

NCT06013241

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?