Similarities and Differences of Biological Therapies for Severe Asthma.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Severity of Treatment-Related Adverse Events recorded throughout the study.
研究概览
简要总结
This is an ambispective multicenter longitudinal observational study to evaluate the efficacy and safety profile of biological therapies in patients diagnosed with severe asthma in real life conditions.
详细描述
The use of biologicals to treat severe asthma has been implemented in a regular basis while information on long term effectiveness and safety is lacking. It is necessary to establish strategies to closely monitor the possible occurrence of reactions, adverse effects of innovative biological medicines used to treat severe asthma.
In this study the investigators want to evaluate the comparative effectiveness, utilization patterns, long-term safety, and use in special groups in real-life conditions in severe asthma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of any age: adults and children.
- •Diagnosis of severe asthma as given by the treating physician, and defined as an asthma that remains uncontrolled in despite adherence with maximal optimized therapy and treatment of contributed factors, or asthma that worsens when high dose treatment is decreased.
- •Being treated or not (control group) with biological drugs.
- •Signed Informed Consent.
排除标准
- 未提供
结局指标
主要结局
Severity of Treatment-Related Adverse Events recorded throughout the study.
时间窗: 2 years after inclusion
Change of asthma control during the treatment.
时间窗: 2 years after inclusion
Number of asthma exacerbations, change in FEV1, ACT, and blood eosinophilia, need of add-on medication, inhaled medication and systemic corticosteroids.
Treatment dose scheduling and changes of dose throughout the study.
时间窗: 2 years after inclusion
Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study.
时间窗: 2 years after inclusion
Number of treatment discontinuations and causes of interruption throughout the study.
时间窗: 2 years after inclusion
次要结局
未报告次要终点