Идёт набор NCT06750289

Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

Фаза III С лечением Eosinophilic Asthma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ICS-LABA, benralizumab, Placebo for Benralizumab.
Кому может быть актуально: Состояния в реестре: Eosinophilic Asthma. Базовые параметры: 12 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Болгария, Канада, Китай, Франция +8
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

BRISOTE: A Multicentre, Randomised, Double-Blind, Parallel Group, Active-Controlled, Phase 3b Study to Evaluate the Efficacy and Safety of Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose Inhaled Corticosteroid Plus Long-acting β2-Agonist.

Обзор

This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.

Подробное описание

This is a randomized, double-blind, active-controlled, parallel group global study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).

Вмешательства

Комбинированный продукт ICS-LABA
ICS-LABA inhalation
Комбинированный продукт benralizumab
Benralizumab. SC injection.
Комбинированный продукт Placebo for Benralizumab
Placebo for Benralizumab (aka, "placebo"). SC injection.

Первичные конечные точки

Annualized asthma exacerbation rate [Срок оценки: Baseline through Week 48]

Вторичные конечные точки (7)

Change in Saint George's Respiratory Questionnaire (SGRQ) total score [Срок оценки: Baseline through Week 48]
Change in pre-bronchodilator FEV1 [Срок оценки: Baseline through Week 48]
Change in Asthma control questionnaire (ACQ) scale score. [Срок оценки: Baseline through Week 48.]
Time to first asthma exacerbation [Срок оценки: Baseline through Week 48.]
Annualized asthma exacerbation rate associated with an emergency/urgent care visit or a hospitalization [Срок оценки: Baseline through Week 48.]
Number and proportion of participants that meet each component of a 4-component clinical remission composite [Срок оценки: Week 24 and Week 48.]
Safety Adverse Event (AEs), Serious Adverse Event (SAEs), Adverse event leading to treatment discontinuation (DAEs.) [Срок оценки: Baseline through Week 48.]

Критерии участия

Критерии включения

Written informed consent
Participant must be 12 to 75 years of age
Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit (V) 1.
Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids).
Weight of ≥ 35 kg.
Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted
Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent.
ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3.
Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol.
Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol.
At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary.

Критерии исключения

Important pulmonary disease other than asthma at the discretion of the investigator, or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts.
Asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol.
Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator's discretion)
Concurrent participation in another clinical study with an IP or a post-authorisation safety study.
History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Четверное слепое
Основная цель: Лечение

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