NCT07214753招募中不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 335
- 试验地点
- 49
- 主要终点
- Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition
时间窗: 24 months
Number and percentage of patient who met the 4 remission criteria (complete or partial) at 12 months and maintained up to 24months
次要结局
- Change in mOCS use and daily dose(3, 6, 12 and 24 months)
- Number and percentage of patients achieving the criteria for clinical remission(3, 6, 12 and 24 months)
- Rate of any and SA exacerbations(3, 6, 12 and 24 months)
- Mean change in FEV1 - pre-BD(3, 6, 12 and 24 vs baseline)
- Mean changes in FEV1 - post-BD(3, 6, 12 and 24 months vs baseline)
- Mean changes in FEV1 % predicted - pre-BD(3, 6, 12 and 24 months vs baseline)
- Mean changes in FEV1 % predicted - post-BD(3, 6, 12 and 24 months vs baseline)
- Mean changes in FVC pre-BD(3, 6, 12 and 24 months vs baseline)
- Mean changes in FVC post-BD(3, 6, 12 and 24 months vs baseline)
- Mean changes in pre-BD FEV1/FVC(3, 6, 12 and 24 months vs baseline)
- Mean changes in pre-BD FEF 25-75(3, 6, 12 and 24 months vs baseline)
- Mean changes in post-BD FEF 25-75(3, 6, 12 and 24 months vs baseline)
- Mean changes in post-BD FEV1/FVC(3, 6, 12 and 24 months vs baseline)
- Change in inhaled maintenance therapy and inhaled corticosteroid (ICS/LABA/LAMA, ICS/LABA) use and dosage(3, 6, 12 and 24 months)
- Mean changes in pre-BD FEV1/FVC(3, 6, 12 and 24 months vs baseline)
- Number and percentage of patients achieving the criteria for clinical remission(3, 6, 12 and 24 months)
- Rate of any and SA exacerbations(3, 6, 12 and 24 months)
- Mean change in Asthma Control Test (ACT) score(1, 3, 6, 12 and 24 months vs baseline)
- Mean change in FEV1 - pre-BD(3, 6, 12 and 24 vs baseline)
- Mean changes in FEV1 - post-BD(3, 6, 12 and 24 months vs baseline)
- Mean changes in Asthma Control Questionnaire (ACQ) score(1, 3, 6, 12 and 24 months vs baseline)
- Mean changes in pre-BD FEF 25-75(3, 6, 12 and 24 months vs baseline)
- Mean changes in post-BD FEF 25-75(3, 6, 12 and 24 months vs baseline)
- Mean changes in FEV1 % predicted - pre-BD(3, 6, 12 and 24 months vs baseline)
- Mean changes in FEV1 % predicted - post-BD(3, 6, 12 and 24 months vs baseline)
- Mean changes in FVC pre-BD(3, 6, 12 and 24 months vs baseline)
- Mean changes in FVC post-BD(3, 6, 12 and 24 months vs baseline)
- Mean changes in post-BD FEV1/FVC(3, 6, 12 and 24 months vs baseline)
- Change in inhaled maintenance therapy and inhaled corticosteroid (ICS/LABA/LAMA, ICS/LABA) use and dosage(3, 6, 12 and 24 months)
- Change in mOCS use and daily dose(3, 6, 12 and 24 months)
研究者
研究点 (49)
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