Response to Bronchodilation With Tiotropium Plus Salbutamol Correlates With Radiologic Morphology of the Lung in COPD of the Emphysematous Phenotype
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- post-bronchodilator FEV1 change
研究概览
简要总结
To assess response to bronchodilation with tiotropium plus salbutamol in patients with severe emphysema and analyze relationships between bronchoreversibility response and semiquantitative computed-tomography based emphysema severity measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologic evidence of severe heterogeneous emphysema
- •GOLD COPD class III-IV
- •No other significant pulmonary comorbidity
- •Quit smoking since at least 4 months
排除标准
- 未提供
研究组 & 干预措施
Bronchodilators
Patients with severe heterogeneous emphysema selected as potential candidtes for lung volume reduction surgery.
Bronchodilators employed for the study include albuterol 200µg and tiotropium bromide 18 µg administered by puffs following a first spirometry and plethysmography performed after a washout period of 48h from all bronchodilators and subsequently repeated within 30 min after bronchodilators administration.
干预措施: Bronchodilators (Drug)
结局指标
主要结局
post-bronchodilator FEV1 change
时间窗: 1 h
Assessed by spirometry carried out before and after administration of bronchodilators
post-bronchodilator change in FVC
时间窗: 1h
Assessed by spirometry carried out before and after administration of bronchodilators
次要结局
未报告次要终点
研究者
Eugenio Pompeo
Associate Professor
University of Rome Tor Vergata