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Идёт набор NCT07214753

A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy

— Наблюдательное Severe 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: benralizumab.
Кому может быть актуально
Состояния в реестре: Severe Eosinophilic Asthma. Базовые параметры: от 18 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
Италия
Следующий шаг
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Официальное название

ItAlian, Multicenter, Observational, Prospective sTudy to Evaluate the acHievement of Clinical rEmission and immuNomodulation in Severe Eosinophilic Asthma Patients Treated With Benralizumab - the ATHENA Study

Обзор

This is an observational, multicenter, prospective study on patients with severe eosinophilic asthma treated with benralizumab aimed at evaluating the achievement of partial and complete clinical remission.

Подробное описание

The ATHENA study aims to expand real-world evidence on benralizumab role in clinical practice, specifically evaluating its effectiveness in achieving clinical remission (complete and partial), as defined by SANI. Additionally, given the growing importance of biomarkers in asthma research, this study seeks to further investigate benralizumab immunological effects, potentially contributing to a deeper understanding of asthma pathophysiology and addressing existing knowledge conundrum. Additionally, the study will consolidate long-term safety data.

Вмешательства

  • Биопрепарат benralizumab
    30mg s.c. as per SmPC

Первичные конечные точки

  • Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition [Срок оценки: 24 months]
Вторичные конечные точки (12)
  • Number and percentage of patients achieving the criteria for clinical remission [Срок оценки: 3, 6, 12 and 24 months]
  • Rate of any and SA exacerbations [Срок оценки: 3, 6, 12 and 24 months]
  • Mean change in Asthma Control Test (ACT) score [Срок оценки: 1, 3, 6, 12 and 24 months vs baseline]
  • Mean changes in Asthma Control Questionnaire (ACQ) score [Срок оценки: 1, 3, 6, 12 and 24 months vs baseline]
  • Mean change in FEV1 - pre-BD [Срок оценки: 3, 6, 12 and 24 vs baseline]
  • Mean changes in FEV1 - post-BD [Срок оценки: 3, 6, 12 and 24 months vs baseline]
  • Mean changes in FEV1 % predicted - pre-BD [Срок оценки: 3, 6, 12 and 24 months vs baseline]
  • Mean changes in FEV1 % predicted - post-BD [Срок оценки: 3, 6, 12 and 24 months vs baseline]
  • Mean changes in FVC pre-BD [Срок оценки: 3, 6, 12 and 24 months vs baseline]
  • Mean changes in FVC post-BD [Срок оценки: 3, 6, 12 and 24 months vs baseline]
  • Mean changes in pre-BD FEV1/FVC [Срок оценки: 3, 6, 12 and 24 months vs baseline]
  • Mean changes in pre-BD FEF 25-75 [Срок оценки: 3, 6, 12 and 24 months vs baseline]

Критерии участия

Критерии включения

  • Adults (≥ 18 years old) diagnosed with severe uncontrolled eosinophilic asthma.
  • Benralizumab has been prescribed according to the approved label and local reimbursement criteria
  • Provision of signed Informed Consent Form (ICF) prior to any study-related activities
  • Benralizumab has been initiated within 7 days prior to study enrollment or is planned to be initiated within 7 days after enrollment (in the latter case, provided that the decision to prescribe benralizumab is made prior to the decision to enroll the patient in the study).

Критерии исключения

  • Benralizumab treatment within the 12 months prior to study enrollment and up to 8 days before enrollment
  • Previous participation (in the 12 months before enrollment), current participation or plan to participate within the follow up period to any other clinical trial.
  • Contraindication to benralizumab as per current Summary of Product Characteristics (SmPC).
  • Pregnant or lactating women.
  • patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the Investigator's judgement.
  • Previous or concomitant use of omalizumab, reslizumab, dupilumab, tezepelumab or mepolizumab without washout period as per clinical practice

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 28 центров
  • Research Site — Salerno
  • Research Site — Padova
  • Research Site — Teramo
  • Research Site — Treviso
  • Research Site — Varese
  • Research Site — Bari
  • Research Site — Bergamo
  • Research Site — Bologna
  • … и ещё 20 центров

Идентификаторы

NCT: NCT07214753 · D3250R00141

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗