Phase 1 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- SAEs - Safety of the procedure from initiation of treatment through hospital discharge.
研究概览
简要总结
The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.
详细描述
Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.
Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Biologic Lung Volume Reduction (BLVR) System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety of the BLVR System in patients with advanced emphysema.
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 heterogeneous emphysema
- •Age >/= 40
- •Clinically significant dyspnea
- •Failure of standard medical therapy to relieve symptoms
- •Pulmonary function tests with protocol-specified ranges
排除标准
- •Alpha-1 protease inhibitor deficiency
- •Tobacco use within 16 weeks of initial clinic visit
- •Body mass index < 15 kg/m2 or > 35 kg/m@
- •Clinically significant asthma, chronic bronchitis or bronchiectasis
- •Allergy or sensitivity to tetracycline
- •Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior endobronchial valve placement, prior airway stent placement or prior pleurodesis
研究组 & 干预措施
Single Treatment
Experimental Treatment
干预措施: BLVR System (Drug)
结局指标
主要结局
SAEs - Safety of the procedure from initiation of treatment through hospital discharge.
时间窗: 1 week post treatment
SAEs - Safety of the treatment through Week 12.
时间窗: 12 weeks post procedure
次要结局
- SAEs - Safety of the treatment through Week 48.(48 weeks post treatment)
- Evaluation of radiologic changes.(12 weeks post treatment)
- Improvement in exercise capacity.(12 weeks post treatment)
- Improvement in quality of life.(12 weeks post treatment)
- Decrease in trapped gas.(12 weeks post treatment)
- Improvement in lung function.(12 weeks post trreatment)
- Improvement in symptoms.(12 weeks post treatment)