NL-OMON37128已完成3 期
Study of the AeriSeal® System for HyPerInflation Reduction in Emphysema (ASPIRE) - ASPIRE Trial
AERIS Therapeutics0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •advanced upper lobe emphysema on CT
- •mMRC 2 or higher
- •6-MWD > 150 m post pulmonary rehab
- •post BD FEV < 50 % pred.
- •TLC > 100 % pred.
- •RV > 150 % pred.
- •DLco >= 20% and <= 60% pred.
- •non-smoking 16 weeks prior to study
排除标准
- •Body mass index < 15 kg/m2 or > 35 kg/m2
- •Alpha1-antitrypsin serum level of <80 mg/dL (i.e. < 11 µmol/L) at screening
- •Female patient pregnant or breast-feeding
- •Clinically significant asthma, chronic bronchitis, bronchiectasis or, pulmonary hypertension
- •Three or more COPD exacerbations requiring hospitalization within 1 year of screening or a COPD exacerbation requiring hospitalization within 8 weeks of Screening
- •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
- •Significant comorbidity that carries prohibitive risks
- •CT scan: Presence of the following radiologic abnormalities: Unstable pulmonary nodule on CT scan greater than 1.0 cm in diameter, infiltrate, interstitial lung disease, significant pleural disease, giant bullous disease (> 10 cm)
- •Requirement for mechanical ventilator support (invasive or non-invasive)
研究者
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