Effet du Mepolizumab Sur la décroissance de la corticothérapie systémique Chez Des Patients Avec un Asthme éosinophilique sévère Etude Observationnelle, Suivi de Cohorte Via Une ATU Nominative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma.
研究概览
简要总结
The primary objective of the study is to measure the effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma.
Asthma is a chronic inflammatory disease of the airways that affects 5 to 10% of adults and children. Despite current treatments that are often effective, 10% of patients are not controlled by inhaled therapies. These severe asthma require regular use of systemic corticosteroids in 30 to 40% of cases. In this context, the use of glucocorticoids is associated with many more or less serious adverse effects, but still affecting the patient's quality of life. Several treatments have already been proven to save systemic steroids (theophylline, anti-leukotrienes, golimumab ...). On the other hand, none is currently recommended because of a risk / benefit ratio that is too high.
Mepolizumab is a human monoclonal antibody that binds to and inactivates interleukin 5. It has recently been shown to be effective in reducing the daily dose of oral corticosteroids and in reducing exacerbations in these patients with severe eosinophilic asthma. It also reduces the number of eosinophils in the blood and sputum and improves the quality of life.
Patients will receive a subcutaneous injection of 100mg mepolizumab every 4 weeks for one year, for a total of 12 injections.
In France, this treatment was subject to a Temporary Authorization for Nominative Use in severe eosinophilic asthma and is reserved for hospital use.
The injections will be done in HDJ Pneumology CHU Grenoble Alpes and patients will be followed monthly during injections and one month after the end of injections.
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
- •Severe eosinophilic asthma
- •Patient on inhaled therapy with inhaled corticosteroid and long-acting bronchodilator for at least 6 months
- •Patient under oral corticosteroid therapy (prednisolone or prednisone) for at least 6 months and unmodified in the last 4 weeks before the first injection
- •Patient able to provide informed and written consent
- •Obtaining the temporary authorization for nominative use for mepolizumab
排除标准
- •Chronic pulmonary pathology other than asthma
- •Active neoplasia
- •Active liver disease
- •Serious and uncontrolled cardiovascular pathology (LVEF less than 30%, NYHA IV, ...)
- •Other eosinophilic pathology (Churg & Strauss syndrome, parasitic infection, ...)
- •Hypersensitivity to mepolizumab or excipient
- •Immunity disorders
- •Patient not affiliated to a social security system
研究组 & 干预措施
mepolizumab
Patients will receive a subcutaneous injection of mepolizumab 100 mg every 4 weeks for one year, for a total of 12 injections
干预措施: Mepolizumab (Drug)
结局指标
主要结局
Effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma.
时间窗: 13 months
Rate of decrease in systemic corticosteroids between the day of the first injection and one month after the last injection.
次要结局
- Asthma control(Every month during 13 months)
- Improving quality of life(Every month during 13 months)
- Improvement of respiratory functional explorations, Forced Expiratory Volume(Every month during 13 months)
- Improvement of respiratory functional explorations(Every month during 13 months)
- Decrease in the number of exacerbations(Assessed every month during 13 months)