Phase 2 Study of the 20 mL Biologic Lung Volume Reduction (BLVR) System in Patients With Homogeneous or Upper Lobe Predominant Emphysema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 8
- 主要终点
- reduction in gas trapping
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation.
详细描述
Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery (LVRS) involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. LVRS, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.
Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System which is intended to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung or in the case of homogeneous disease, areas that are less active as shown by the extent of regional blood flow. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable hydrogel. The hydrogel acts to reduce lung volume by permanently collapsing and sealing the treated areas of the lung. This provides room within the chest to allow the remaining portions of the lung to function better.
Aeris' BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous (upper lobe predominant) emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
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
- 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 homogeneous or upper lobe predominant emphysema demonstrated by CT scan
- •age >/= 40 years
- •clinically significant dyspnea
- •failure of standard medical therapy (typically inhaled beta agonist & inhaled anticholinergic) to relieve symptoms
- •pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted & experiencing < 30% or 300 mL improvement using bronchodilator; total lung capacity > 110% predicted; residual volume > 150% predicted)
- •6 Minute Walk Distance >/= 150 m
排除标准
- •tobacco use within 4 months of initial visit or during study
- •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, endotracheal valve placement, airway stent placement or pleurodesis
- •comorbid condition that could adversely influence outcomes
- •inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
- •history of renal infarction or renal failure lung perfusion scan indicating > 20% of blood flow to either upper lung field or 30% total to both upper lung fields if homogeneous emphysema
研究组 & 干预措施
Single
all patients are treated with the experimental therapy
干预措施: Biologic Lung Volume Reduction (Biological)
结局指标
主要结局
reduction in gas trapping
时间窗: 12 weeks post treatment
次要结局
- improvement in exercise capacity(12 weeks post treatment)
- improvement in expiratory flow(12 weeks post treatment)
- improvement in vital capacity(12 weeks post treatment)
- improvement in dyspnea sysmptoms(12 weeks post treatment)
- improvemnet in respiratory quality of life(12 weeks post treatment)
- serious adverse events(through 2 years)