Taiwan Severe Asthma Biologic Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Status of Asthma exacerbations
研究概览
简要总结
This is a prospective multi-centers cohort study for registration adult patients with severe asthma and were reimbursed biologics treatment in Taiwan.
The goal of this observational study is to discover the real-world effectiveness, the impact of initiating, switching of biologics, and the possible prediction factors for selecting the best treatment option for patients.
The main question[s] it aims to answer are:
- Determine risk factors associated with poor asthma control.
- Support the development of effectiveness and safety of therapeutic principles
- To discover the real-world effectiveness of different biologics ( Clinical remission)
- To discover the impact of initiating biologics for severe asthma patients.
- To evaluate the prevalence of biologics switching and its benefits for patients.
- To compare the achievement rate of clinical remission among different biologics.
Participants who are treated either with omalizumab, mepolizumab, benralizumab dupilzumab or Tezepelumab after January 1, 2020 will be included in the study.
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
- •Provision of informed consent prior to any study specific procedures.
- •Patient should be reviewed as well as confirmed by the National Health Insurance Administration (NHIA) or by the study board member as a Severe Asthma case.
- •Female and male aged over 18 years old.
- •Patients who are treated either with omalizumab, mepolizumab, or benralizumab after January 1, 2020.
排除标准
- •Lack of informed consent for participation.
- •History of Biologic usage before January 1, 2020, should be ruled out.
- •The washout period should be at least 12 months. In other words, the enrolled patients should have no experience in receiving a biological treatment or in participating relative clinical trial before his/her biologic initiation.
- •Comorbid pulmonary diseases (e.g.: Chronic Obstructive Pulmonary Disease, Bronchiectasis, Pulmonary Fibrosis, etc.) or risk factors (e.g.: smoking or environmental exposure, etc..) that could be associated with pulmonary or systemic diseases, other than Asthma.
研究组 & 干预措施
Benralizumab
Severe asthma patients who are treated with benralizumab after January 1, 2020.
干预措施: Biological Treatment for severe asthma patients (Biological)
Mepolizumab
Severe asthma patients who are treated with mepolizumab after January 1, 2020.
干预措施: Biological Treatment for severe asthma patients (Biological)
Dupilzumab
Severe asthma patients who are treated with dupilzumab after January 1, 2020.
干预措施: Biological Treatment for severe asthma patients (Biological)
Tezepelumab
Severe asthma patients who are treated with Tezepelumab after January 1, 2020.
干预措施: Biological Treatment for severe asthma patients (Biological)
Omalizumab
Severe asthma patients who are treated with omalizumab after January 1, 2020.
干预措施: Biological Treatment for severe asthma patients (Biological)
结局指标
主要结局
Status of Asthma exacerbations
时间窗: 6 months
Annual frequency of exacerbations after biologic initiation.
Change of Pre-BD FEV1 (%pred)
时间窗: 6 months
Measure the change of Pre-BD FEV1 (%pred) after biologic initiation. FVC (L) FEV1(L)
Status of Asthma Control
时间窗: 6 months
Mean change in Asthma Control Test score after biologic initiation.
Reduction of daily oral corticosteriod dose
时间窗: 6 months
Percentage of daily oral corticosteroids dose reduction after biologic initiation.
次要结局
- Disease Prognosis(6 months)
- Mortality(6 months)
研究者
Pin-Kuei Fu, MD, PhD
Director of Clinical Trail Center
Taichung Veterans General Hospital