Therapheutic optimization of omalizumab in allergic severe asthma patients by dose and frequency of administration adjustment
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- The aim of this study is to value if a 50% omalizumab dose reduction in patients who suffer from allergic asthma, will allow to keep the same control of clinical stability. It is assessed by the lack of crisis, quality life and lung function.
研究概览
简要总结
The aim of this study is to value if a 50% omalizumab dose reduction in patients who suffer from allergic asthma, will allow to keep the same control of clinical stability. It is assessed by the lack of crisis, quality life and lung function.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients: 18 - 80 years.
- •Before 6-month, the patient must have kept the follow inclusion criteria: Omalizumab adherence: 100%.
- •Before 6-month, the patient must have kept the follow inclusion criteria: ACT ≥
- •Before 6-month, the patient must have kept the follow inclusion criteria: Stable FEV1 (>80%) or the best value of those patients that don't reach the 80% due to previous deterioration lung function.
- •Before 6-month, the patient must have kept the follow inclusion criteria: Don't make use of oral corticosteroids.
- •Before 6-month, the patient must have kept the follow inclusion criteria: Lack of emergency visits or hospital admissions.
- •Patients shall go or shall answer to in-person or telephonic visits.
- •Patients must understand, accept, and sign the informed consent. A legal tutor can also give the authorisation to participate in the study.
排除标准
- •Those patients who do not keep the inclusion criteria (see inclusion criteria).
- •Excluded patients: omalizumab for the treatment of other diseases, use of immunosuppressors or oral corticosteroids and those who have a diagnostic of other chronic respiratory diseases (such as cystic fibrosis, COPD, cancer, or immunodeficiency disease).
- •Don't consent of legal tutor.
结局指标
主要结局
The aim of this study is to value if a 50% omalizumab dose reduction in patients who suffer from allergic asthma, will allow to keep the same control of clinical stability. It is assessed by the lack of crisis, quality life and lung function.
The aim of this study is to value if a 50% omalizumab dose reduction in patients who suffer from allergic asthma, will allow to keep the same control of clinical stability. It is assessed by the lack of crisis, quality life and lung function.
次要结局
未报告次要终点
研究者
Pneumology
Scientific
Consorci Mar Parc De Salut De Barcelona