A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 16
- 主要终点
- Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)
研究概览
简要总结
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 Homogeneous Emphysema. Patients will be followed up for 12 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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Homogeneous emphysema
- •15% ≤ FEV1 ≤ 45% predicted
- •TLC > 100% predicted
- •RV ≥ 200% predicted
- •6MWT ≥ 150 m
- •Non-smoker > 8 weeks prior to study entry
- •Absence of Collateral Ventilation in the target lobe
排除标准
- •Active pulmonary infection
- •More than 3 exacerbations with hospitalizations over the past 12 months
- •Pulmonary hypertension (sPAP > 45 mmHg)
- •MI or other relevant CV events in the past 6 months
- •Alpha-1 antitrypsin deficiency
- •Bronchiectasis
- •Prior LVR or LVRS procedure
- •> 20% difference in perfusion between right and left lung
- •Hypercapnia (paCO2 > 55 mmHg
- •Use of more than 25 mg/day prednisolone or equivalent
- •Severe bullous emphysema
- •Systemic or malignant disease with high death probability within 12 months
研究组 & 干预措施
ELVR with Endobronchial Valves
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
干预措施: Endobronchial Valve (Device)
Standard of Care
Patients will receive optimal drug therapy and medical management according to clinical practice.
结局指标
主要结局
Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)
时间窗: At baseline and after 3 months
Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.
次要结局
- Percent Change in Target Lobe Volume for EBV Group (ITT Population)(At baseline and after 3 months)
- Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months(At baseline and after 3 months)
- Percent Change in Residual Volume (RV) at 3 Months(At baseline and after 3 months)
- Absolute Change in Target Lobe Volume for EBV Group (ITT Population)(At baseline and after 3 months)
- Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months(At baseline and after 3 months)
- Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months(At baseline and after 3 months)
- Absolute Change in Residual Volume (RV) at 3 Months(At baseline and after 3 months)
- Percent Predicted Change in Residual Volume at 3 Months(At baseline and after 3 months)
- Absolute Change in Six-Minute Walk Distance at 3 Months(At baseline and after 3 months)
- Percent Change in Six-Minute Walk Distance at 3 Months(At baseline and after 3 months)
- Absolute Change in the SGRQ Total Score From Baseline to 3 Months(At baseline and after 3 months)
- Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months(At baseline and after 3 months)
- Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months(At baseline and after 3 months)
- Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months(At baseline and after 3 months)
- Absolute Change in the CAT Total Score From Baseline to 3 Months(At baseline and after 3 months)
- Percent Change (%) in CAT Total Score From Baseline to 3 Months(At baseline and after 3 months)
- Absolute Change in EQ-5D Summary Index From Baseline to 3 Months(At baseline and after 3 months)
- Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months(At baseline and after 3 months)
- Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months(At baseline and after 3 months)