A Prospective Randomized Controlled Trial on the Systemic Effects of Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Endurance time
研究概览
简要总结
Rationale: The published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment in the GOLD-COPD2017 guidelines. Interaction with pulmonary rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary consequences are all topics to gain more insight in. This importantly, to further develop and optimize this innovative and personalized therapy.
Objective: To study in detail the impact and optimal timing of pulmonary rehabilitation (PR) on exercise physiology and patient-reported outcomes and the impact of the bronchoscopic lung volume reduction treatment using endobronchial valves (EBV) on cardiopulmonary function, metabolism and changes in body composition.
Study design: This study is a randomized controlled trial with 3 study-arms. Group 1 will first follow a PR program and afterwards undergo the EBV treatment. Group 2 will first undergo the EBV treatment and approximately 8 weeks later will follow a PR program. Group 3 will only undergo the EBV treatment (and can choose to follow a PR program after completing the 6 month FU visit).
Study population: The study population exist of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment using one-way valves.
Intervention: Most patients will undergo a bronchoscopic lung volume reduction treatment using endobronchial valves and a pulmonary rehabilitation program. One group of patient will under a bronchoscopic lung volume reduction treatment using endobronchial valves and can choose whether they also want to follow a pulmonary rehabilitation program afterwards.
Main study parameters: The main study parameter is the difference in change in endurance time measured by an endurance cycle test between the EBV treatment group and the bronchoscopic lung volume reduction + rehabilitation group (EBV+PR).
详细描述
Rationale: The published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment in the GOLD-COPD2017 guidelines. Interaction with pulmonary rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary consequences are all topics to gain more insight in. This importantly, to further develop and optimize this innovative and personalized therapy.
Objective: To study in detail the impact and optimal timing of pulmonary rehabilitation (PR) on exercise physiology and patient-reported outcomes and the impact of the bronchoscopic lung volume reduction treatment using endobronchial valves (EBV) on cardiopulmonary function, metabolism and changes in body composition.
Study design: This study is a randomized controlled trial with 3 study-arms. Group 1 will first follow a PR program and afterwards undergo the EBV treatment. Group 2 will first undergo the EBV treatment and approximately 8 weeks later will follow a PR program. Group 3 will only undergo the EBV treatment (and can choose to follow a PR program after completing the 6 month FU visit).
Study population: The study population exist of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment using one-way valves.
Intervention: Most patients will undergo a bronchoscopic lung volume reduction treatment using endobronchial valves and a pulmonary rehabilitation program. One group of patient will under a bronchoscopic lung volume reduction treatment using endobronchial valves and can choose whether they also want to follow a pulmonary rehabilitation program afterwards.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1 ≤45%pred AND FEV1/FVC <70%.
- •TLC >100%pred AND RV>175%pred.
- •>50% emphysema destruction @-910HU.
- •>95% complete major fissure measured by quantitative CT analysis.
- •Non-smoking >6 months.
- •Signed informed consent.
排除标准
- •PaCO2>8.0 kPa, or PaO2<6.0kPa.
- •6-minute walk test <160m.
- •Significant chronic bronchitis, bronchiectasis, or other infectious lung disease.
- •3 of more hospitalizations due to pulmonary infection within last 12 months before baseline assessments
- •Previous lobectomy, LVRS, or lung transplantation.
- •LVEF<45% and or RVSP>50mmHg.
- •Anticoagulant therapy which cannot be weaned off prior to procedure.
- •Patient is significantly immunodeficient.
- •Involved in other pulmonary drug studies within 30 days prior to this study.
- •Pulmonary nodule which requires intervention
- •Any disease or condition that interferes with completion of initial or follow-up assessments
研究组 & 干预措施
Group 1:PR-EBV treatment
Follow a Pulmonary rehabilitation program PRIOR to the EBV treatment
干预措施: Pulmonary rehabilitation (Behavioral)
Group 1:PR-EBV treatment
Follow a Pulmonary rehabilitation program PRIOR to the EBV treatment
干预措施: EBV treatment (Device)
Group 2: EBV treatment-PR
Follow a Pulmonary rehabilitation program AFTER the EBV treatment
干预措施: Pulmonary rehabilitation (Behavioral)
Group 2: EBV treatment-PR
Follow a Pulmonary rehabilitation program AFTER the EBV treatment
干预措施: EBV treatment (Device)
Group 3: EBV treatment
Only EBV treatment
干预措施: EBV treatment (Device)
结局指标
主要结局
Endurance time
时间窗: After 6 months
The difference in change in endurance time measured by an endurance cycle test between the EBV treatment group and the bronchoscopic lung volume reduction + rehabilitation group (EBV+PR).
次要结局
- Pulmonary rehabilitation1(After 6 months)
- Pulmonary rehabilitation2(After 6 months)
- Pulmonary rehabilitation3(After 6 months)
- Patient reported outcomes(After 6 months)
- Cardiopulmonary function(After 8 weeks)
- Metabolism and change in body composition(After 8 weeks)
研究者
Dirk-Jan Slebos
dr. D.J. Slebos
University Medical Center Groningen