Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)
研究概览
简要总结
Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.
详细描述
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 25 patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency. All patients will undergo treatment at one study centre in Heidelberg. Therapy of all patients consists of implantation of intrabronchial valves (IBV, Spiration, Olympus) in the most emphysematous destroyed lobe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
- •alpha1 antitrypsin deficiency (< 80 mg/dl), genotype: PiZS, PiZZ, Pi0/0
- •heterogenous emphysema
排除标准
- •homogenous emphysema
- •significant bronchiectasis
- •severe concomitant diseases
- •pregnancy
结局指标
主要结局
Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)
时间窗: 3 months
次要结局
- Number of major complications(3 months)
- Evaluation of IBV migration rate(3 months)
- Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC)(3 months)
- Average changes in 6-minute-walk-distance(3 months)
研究者
Felix JF Herth
Prof. Dr. med. Felix Herth
Heidelberg University