Study on Benralizumab and Mometasone Furoate for Patients with Severe Eosinophilic Chronic Rhinosinusitis with Nasal Polyps and Asthma

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What is this study about?

This clinical trial is focused on studying the effects of a medication called benralizumab in patients with a condition known as eosinophilic chronic rhinosinusitis with nasal polyps. This condition involves long-term inflammation of the sinuses and the growth of polyps in the nasal passages, which can lead to symptoms like nasal blockage and difficulty breathing. The study will compare the effects of benralizumab, which is given as an injection under the skin, to a placebo. Another medication, mometasone furoate, a nasal spray, is also involved in the study.

The purpose of the study is to evaluate how well benralizumab can reduce the size of nasal polyps and improve symptoms such as nasal blockage. Participants will receive either benralizumab or a placebo over a period of time, and their progress will be monitored through regular check-ups. The study will also look at other factors, such as changes in the sense of smell and the need for surgery or additional medication.

Throughout the study, participants will be asked to report their symptoms and any changes they experience. The study aims to provide valuable information on the effectiveness and safety of benralizumab for treating eosinophilic chronic rhinosinusitis with nasal polyps, potentially offering a new treatment option for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current symptoms.

Eligibility criteria include being between 18 to 75 years old, having a history of nasal polyps and asthma, and ongoing symptoms for at least 12 weeks.

2 baseline evaluation

A baseline evaluation is performed to measure the severity of nasal polyps and nasal blockage. This involves nasal endoscopy and patient-reported scores.

The nasal polyp score (NPS) and nasal blockage score (NBS) are recorded to establish a starting point for the study.

3 treatment phase

Participants are randomly assigned to receive either benralizumab or a placebo. Benralizumab is administered as a 30 mg solution for injection under the skin.

The treatment is given at regular intervals as specified by the study protocol.

4 ongoing assessments

Throughout the study, regular assessments are conducted to monitor changes in nasal polyp size and nasal blockage.

Participants report any changes in symptoms, including difficulty with the sense of smell and overall nasal symptoms.

5 final evaluation

At the end of the study period, a final evaluation is conducted to assess the overall effectiveness of the treatment.

This includes a comparison of the initial and final nasal polyp scores and nasal blockage scores.

Who Can Join the Study?

Must be a female or male aged between 18 and 75 years old.
Must have a blood eosinophil count greater than 2% or at least 150 cells per microliter. Eosinophils are a type of white blood cell involved in allergic reactions and asthma.
Must have been using intranasal corticosteroids (INCS), which are medications sprayed into the nose to reduce inflammation, for at least 4 weeks before joining the study and continue using them during the screening period.
Must have a history of using systemic corticosteroids (SCS), which are medications taken by mouth or injection to reduce inflammation, or have had surgery for CRSwNP (chronic rhinosinusitis with nasal polyps).
Must have bilateral sinonasal polyposis, meaning nasal polyps in both nostrils, with a nasal polyp score (NPS) of 5 at the time of joining the study and randomization. Each nostril should have a score of at least 2.
Must have had ongoing symptoms for at least 12 weeks before joining the study.
Must report a moderate to severe nasal blockage score (NBS) of 2 or more at the time of joining the study. This score reflects how blocked the nose feels.
Must have a bi-weekly average NBS of 1.5 or more at the time of randomization.
Must have a SNOT-22 total score of 20 or more at the time of joining the study and randomization. SNOT-22 is a questionnaire that measures the impact of sinus symptoms on quality of life.
Must have a documented diagnosis of asthma by a physician.

Who Cannot Join the Study?

Patients who do not have severe CRSwNP (Chronic Rhinosinusitis with Nasal Polyps) and asthma.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included.
Patients who are not considered part of a vulnerable population.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Universitair Ziekenhuis Gent	Gent	Belgium
Komarom-Esztergom Varmegyei Szent Borbala Korhaz	Tatabanya	Hungary
Promed P.Lach R.Glowacki Sp. j.	Cracow	Poland
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
MBAL Serdika Ltd.	Sofia	Bulgaria
Centrum Alergologii Sp. z o.o.	Lublin	Poland
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Clinexpert Kft.	Budapest	Hungary
Universita’ Di Pisa	Pisa	Italy
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Cklduehpo Urvlodffanlzzg Sbjeekqop	Woluwe-Saint-Lambert	Belgium
Mujcnkzq mbxlgjr auzswxz &olhmbz Mhjw &cplliv Ssxnc	Sofia	Bulgaria
Rqdh Mybbgy	Poznan	Poland
Cymfdwr Stkwai i Mmvc Mfrygvbf	Nadarzyn	Poland
Sobcpyz Ktlqboiyeoxvmwqumeqpa	Siofok	Hungary
Mpaymw Bsvdwey – Drvmtjpso	Wroclaw	Poland
Gvubyhnlvpzzrftnn Viuutkkms Puuv Aydjzp Ekxjcqel Otlxti Kklgiz	Gyor	Hungary
Utmmosankf Dongt Svklm Dq Rgwj Ly Szvkssai	Rome	Italy
Upupgvvtda Mheqh Gvpkxmr Og Ctrszrihz	Catanzaro	Italy
Uojizdl Ecqrdewqtcxl Nmreovjeu Ktkz	Budapest	Hungary

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	12.11.2021
Bulgaria	Not recruiting	12.11.2021
Hungary	Not recruiting	12.11.2021
Italy	Not recruiting	12.11.2021
Poland	Not recruiting	12.11.2021

Trial locations

Investigated drugs:

Benralizumab is a medication used in this clinical trial to treat patients with eosinophilic chronic rhinosinusitis with nasal polyps. It works by targeting and reducing the number of eosinophils, which are a type of white blood cell that can contribute to inflammation and the formation of nasal polyps. The goal of using benralizumab in this study is to decrease the size of nasal polyps and improve symptoms like nasal blockage, as reported by patients.

Investigated diseases:

Chronic rhinosinusitis with nasal polyps

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) – This condition is characterized by the inflammation of the nasal passages and sinuses, leading to the growth of polyps. These polyps can cause nasal blockage, a reduced sense of smell, and facial pressure. The disease often progresses with persistent symptoms that can affect breathing and quality of life. It is commonly associated with other respiratory conditions, such as asthma. Over time, the polyps may increase in size, potentially requiring surgical intervention if they cause significant obstruction or discomfort.

Trial ID:

2023-507987-38-00

Protocol code:

D3252C00002

NCT ID:

NCT04157335

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Benralizumab and Mometasone Furoate for Patients with Severe Eosinophilic Chronic Rhinosinusitis with Nasal Polyps and Asthma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?