A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Percentage change in Forced Expiratory Volume in 1 s (FEV1)
研究概览
简要总结
To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema patients in a controlled trial design setting.
详细描述
The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Heterogeneous Emphysema. Patients will be followed up for 6 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent form signed
- •Heterogeneous emphysema on Chest CT Scanner
- •Intact interlobar fissures adjacent to the target lobe on Chest CT or collateral ventilation negative in the target lobe by Chartis assessment
- •Post bronchodilator Forced expiratory volume in 1 second (FEV1) < 50% predicted
- •Total Lung Capacity > 100% predicted
- •Residual Volume > 150% predicted
- •PaO2 > 45mmHg
- •Post rehabilitation 6 minute walk test > 140m
- •No COPD exacerbation for at least 6 weeks
- •Stopped cigarette smoking for more than 3 months
排除标准
- •Contraindication to bronchoscopy
- •Tuberculosis, pleural effusion, or clinically significant bronchiectasis
- •Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
- •Active pulmonary infection
- •Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
- •Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer...)
- •Inclusion in an other study assessing respiratory treatments
- •Pregnant or lactating woman
结局指标
主要结局
Percentage change in Forced Expiratory Volume in 1 s (FEV1)
时间窗: At baseline and after 3 months
次要结局
- Change in mMRC score(At baseline and after 3, 6 months)
- Percentage change in Forced Expiratory Volume in 1 s (FEV1)(At baseline and after 6 months)
- Change in Total Lung Capacity (TLC)(At baseline and after 3, 6 months)
- Change in FEV1/FVC ratio(At baseline and after 3, 6 months)
- Comparison of the FEV1 using 15% Percentage change as cut-off for clinically significant change(At baseline and after 3, 6 months)
- Change in Residual Volume (RV)(At baseline and after 3, 6 months)
- Change in St George's Respiratory Questionnaire(At baseline and after 3, 6 months)
- Change in 6-Min Walk Test(At baseline and after 3, 6 months)
- Change in BODE index(At baseline and after 3, 6 months)
- Adverse Events and Serious Adverse Events(At each visits)
研究者
Chen Liang_An
MD,PHD
Chinese PLA General Hospital