Bronchoscopic Volume Reduction With Valve Implants After Analysis of Interlobar Fissure Integrity and Measurement of Collateral Ventilation in Patients With Severe, Heterogeneous Emphysema
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Improvement on pulmonary function
研究概览
简要总结
This clinical trial evaluates the impact of catheter-based measurement of interloabr collateral ventilation prior to endoscopic lung volume reduction in patients with hetereogeneous emphysema and complete interlobar fissures in high resolution computed tomography.
详细描述
50 patients (25 per center) with heterogeneous lung emphysema with indication for endoscopic lung volume reduction by valve implantation will be prospectively included in the study. Heterogeneity of emphysema and fissure completeness of the relevant lobe will be proven from high resolution computed tomography (HRCT) prior to enrolment in the study. Fissure integrity will be analyzed by a core radiology. If fissure completeness is proved, patients will be enrolled in the study. All recruited patients will additionally receive a collateral ventilation measurement by using the Chartis® Pulmonary Assement System during a flexible bronchoscopy. Depending on the results of this measurement, patients are divided in two parallel arms: A: complete fissure integrity and low collateral ventilation (CV negative) B: complete fissure integrity and high collateral ventilation (CV positive) Following the CV measurement, each patient will receive valve therapy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •ability to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements
- •severe lung emphysema (FEV1<45%, RV>150%, TLC>100%)
- •pO2>60 mmHg with 4l O2, pCO2 < 60 mmHg at rest
- •heterogeneous lung emphysema diagnosed with HRCT and perfusion scintigraphy
- •confirmed heterogeneity by YACTA®
- •disclosure of parallel channels through relevant interlobar fissures
- •age > 30 years
- •stable COPD without exacerbation 8 weeks prior to screening
- •dose of cortisone< 20 mg prednisone or equivalent OCS
- •non-smoker or ex-smoker who stopped smoking for at least 4 months prior to the screening visit
- •current CoHb < 2,5%
排除标准
- •BMI < 18 mg/kg2
- •significant bronchiectasis with sputum production of 4 tablespoons/day
- •6-minute-walk distance < 150 m
- •myocardial infarction within 6 weeks prior screening visit
- •decompensated heart failure
- •cardiomyopathy with moderate or severe restricted LVF
- •long-term medication with Clopidogrel
- •status after lung resection (Lobectomy/Pneumonectomy)
- •existing pregnancy
- •female subjects of child-bearing potential without acceptable forms of contraception
结局指标
主要结局
Improvement on pulmonary function
时间窗: 12 months
Development of lung function parameters FEV1 and RV/TLC. Increase of FEV1 of 15% and decrease of RV/TLC of 10% compared to baseline will be considered as clinically significant.
次要结局
- Assessment of safety and efficacy(12 months)
研究者
Felix JF Herth
Prof. Dr. med. Felix JF Herth
Heidelberg University