NCT01719263已完成不适用
Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 31
- 主要终点
- Forced expiratory volume in 1-second (FEV1) compared to active comparator
研究概览
简要总结
This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heterogeneous emphysema with upper lobe predominance in both lungs
- •FEV1 between 20% and 45% predicted
- •Residual volume (RV) > 150% predicted
- •Post-rehabilitation 6-minute walk test > 140 meters
排除标准
- •More than 3 COPD related hospitalizations requiring antibiotics in past 12 months
- •FEV1 < 20% predicted
- •DLCO < 20% predicted or immeasurable DLCO
- •Body mass index (BMI) < 18kg/m2 or > 32 kg/m2
- •History of any of the following:
- •Left ventricular ejection fraction (EF) ≤ 40%
- •Myocardial infarction or acute coronary syndrome in previous year
- •Hospitalization due to left ventricular failure in previous 3 years
结局指标
主要结局
Forced expiratory volume in 1-second (FEV1) compared to active comparator
时间窗: Year 1
Quality of Life (SGRQ)
时间窗: Year 1
次要结局
- Responder rate for FEV1 % difference from baseline(Year 1)
- Responder rate 6MWD meter difference from baseline(Year 1)
- Responder rate SGRQ pts difference from baseline(Year 1)
- Lobar Volume Reduction HRCT(Year 1)
研究者
研究点 (31)
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