NCT01822795Unknown3 期
Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.
适应症
试验速览
- 阶段
- 3 期
- 发起方
- CHU de Reims
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- 6-month improvement of the 6-minute walk test
研究概览
简要总结
- BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema.
- METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone.
- EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral emphysema on Chest CT Scanner
- •Post bronchodilator FEV1 < 50 %
- •Total Lung Capacity > 100 %
- •Residual Volume > 220 %
- •Dyspnea score between 2 and 4 based on the mMRC scale
- •Stopped cigarette smoking for more than 8 weeks
- •Pulmonary rehabilitation within the previous twelve months
- •Consent form signed
- •Covered by Medical Insurance
排除标准
- •Post bronchodilator FEV1 < 15%
- •Post-bronchodilator change in FEV1 > 20%
- •Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
- •COPD exacerbation requiring hospital stay within 3 months
- •Pulmonary Hypertension (Pulmonary systolic pressure >50 mmHg on cardiac echo)
- •Patient unable to perform a 6-min walking test in room air
- •Giant bulla of more than 1/3 of the lung field on Chest CT
- •Strictly homogeneous emphysema on Chest CT
- •Clinically significant bronchiectasis
- •Past history of lobectomy, lung volume reduction surgery, lung transplantation
- •Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer...)
- •Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
- •Contra-indication to general anesthesia
- •Oral anticoagulant treatment (antivitamin K)
- •Allergy to nitinol
- •Inclusion in an other study assessing respiratory treatments
- •Patient protected by the law
结局指标
主要结局
6-month improvement of the 6-minute walk test
时间窗: 6 months
6-month improvement of the 6-minute walk test : the percentage of patients showing an improvement of at least 54m will be compared between groups.
次要结局
- Cost-effectiveness(6 and 12 months)
- Dyspnea(6 and 12 months)
- Pulmonary function assessment(6 and 12 months)
- Quality of life(6 and 12 months)
- Morbidity-mortality(6 and 12 months)
研究者
研究点 (18)
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