Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 10
- 主要终点
- Reduction in gas trapping
研究概览
简要总结
Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.
详细描述
Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of advanced upper lobe predominant emphysema
- •age >/= 40 years
- •clinically significant dyspnea
- •failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
- •pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted and experiencing < 30% or 300 mL improvement using bronchodilator; TLC > 110% predicted; RV > 150% predicted)
- •6 Minute Walk Distance >/= 150 m
排除标准
- •alpha-1 protease inhibitor deficiency
- •homogeneous disease
- •tobacco use within 4 months of initial visit
- •body mass index < 15 kg/m2 or > 35 kg/m2
- •clinically significant asthma, chronic bronchitis or bronchiectasis
- •allergy or sensitivity to procedural components
- •pregnant, lactating or unwilling to use birth control if required
- •prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endobronchial valve placement, airway stent placement or pleurodesis
- •comorbid condition that could adversely influence outcomes
- •inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
结局指标
主要结局
Reduction in gas trapping
时间窗: 12 weeks post treatment
SAEs - Safety of treatment and the procedure
时间窗: 2 years
次要结局
- Improvement in vital capacity(12 weeks post treatment)
- Improvement in expiratory flow(12 weeks post treatment)
- Improvement in inspiratory flow(12 weeks post treatment)
- Improvement in dyspnea symptoms (breathlessness)(12 weeks post treatment)
- Improvement in exercise capacity(12 weeks post treatment)
- Improvement in respiratory quality of life(12 weeks post treatment)