NCT01520740终止4 期
Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant Emphysema
Aeris Therapeutics26 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 26
- 主要终点
- Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1)
研究概览
简要总结
This study will evaluate the effects of baseline collateral ventilation status on outcomes following treatment with AeriSeal System in patients with advanced upper-lobe predominant heterogenous emphysema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（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 upper lobe predominant emphysema by CT scan
- •Two (2) subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
- •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):
- •TLC > 100% predicted
- •RV > 150% predicted
- •DLco > or = 20 and < or = 60% 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, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
- •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
- •α-1 antitrypsin serum level of <80 mg/dl (immunodiffusion) or <11µmol/L (nephelometry) at Screening visit in the absence of enzyme replacement therapy. Patients with documented α-1 antitrypsin deficiency requiring replacement therapy are excluded from the study participation.
- •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 diameter)
- •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) and investigational medications within 4 weeks of screening
- •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 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
Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1)
时间窗: 24 Weeks
次要结局
- Change from Baseline in group mean 6 Minute Walk Test (6MWT) distance(24 Weeks)
- Change from baseline in group mean health related quality of life(24 Weeks)
研究者
研究点 (26)
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