NCT01908933撤回3 期
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
Aeris Therapeutics0 个研究点开始时间: 2013年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Volume change by CT
研究概览
简要总结
The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
详细描述
This is a prospective single arm study to evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
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
- 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
- •Willing and able to provide informed consent and to participate in the study
- •Age > or = 40 years at the time of the screening
- •Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan
- •Minimum of 2 subsegments appropriate for treatment
- •MRCD questionnaire score of 2 or greater at screening
- •Failure of medical therapy to provide relief of symptoms
- •Spirometry 15 minutes after administration of bronchodilator (BOTH):
- •FEV1 < 50 % predicted.
- •FEV1/FVC ratio <70 %
- •Lung volumes by plethysmography (BOTH):
- •Total Lung Capacity (TLC) > 100 % predicted
- •Residual Volume (RV) > 150 % predicted
- •Diffusing Capacity of Carbon Monoxide(DLco) > = 20 and < = 60 percent predicted
- •Oxygen saturation (SpO2) > 90 % on < or = 4 L/min supplemental O2, at rest
- •Six-Minute Walk Test distance > or = 150 m
- •Abstinence from smoking for at least 16 weeks prior to screening
排除标准
- •Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation
- •Requirement for ventilator support (invasive or non-invasive)
- •Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit
- •Pulmonary hypertension, defined as:
- •Echocardiogram with estimated peak systolic pressure > 45 mmHg in the presence of tricuspid valve regurgitation stated in the echocardiogram report
- •If the echocardiogram shows peak systolic pressure > 45 mmHg, right heart catheterization is required to rule out pulmonary hypertension, defined as peak systolic pressure > 45 mmHg or mean pressure > 35 mmHg
- •Clinically significant asthma (reversible airway obstruction) or bronchiectasis
- •CT scan: Presence of the following radiologic abnormalities:
- •Pulmonary nodule on CT scan greater that 1.0 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET)
- •Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
- •Significant interstitial lung disease
- •Significant pleural disease
- •Giant bullous disease (a predominant bulla > 10 cm in all dimensions >1 / 3 of the hemithorax)
- •Use of systemic steroids > 20 mg/day or equivalent, immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted)
- •Allergy or sensitivity to medications required to safely undergo AeriSeal System treatment
- •Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the screening visit
- •Body mass index < 15 kg/m2 or > 35 kg/m2
- •Female patient pregnant or breast-feeding or planning to be pregnant in the next year
- •Significant comorbidity that carries prohibitive risks or is associated with less than 2-year expected survival, including any of the following:
- •Active malignancy
- •Stroke or Transient Ischemia Attack (TIA) within 12 months of screening
- •Myocardial infarction within 12 months of screening
- •Congestive heart failure within 12 months of screening defined at clinical evidence of right or left hear failure or left ventricular ejection fraction < 45 % on echocardiogram
- •Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits
结局指标
主要结局
Volume change by CT
时间窗: 28 - 30 weeks
Group mean normalized change from baseline in the volume of the treated lung lobes measured by quantitative CT at 24 weeks post-treatment (defined as the sum of volume change in all treated lobes/number of treatments).
次要结局
- Fraction of patients showing clinically significant improvements from baseline in one or more of the following outcomes at 24 weeks post treatment: Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), Medical Research Council Dyspnea(28 - 30 weeks)
研究者
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