The Measurement and Analysis of Maximal Expiratory Flow Volume Loops at Low Lung Volumes in Children With Cystic Fibrosis and Normal Routine Lung Function.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis
研究概览
简要总结
Goal is to physiologically detect unsuspected small airways obstruction in children and adults with treated heterozygous and homozygous cystic fibrosis. Unsuspected refers to normal routine pre bronchodilator spirometry including normal FEV1(L), FVC (L). and FEV1/FVC%. This is a retrospective study.
详细描述
The current study is based on current investigators previously published patho-physiologic and lung CT studies in small airways intrinsic obstruction, emphysema, and asthma. Current investigators have demonstrated that despite the presence of normal routine spirometry including normal FEV1(L), FVC (L), and FEV1/FVC% that unsuspected small airways obstruction, and emphysema can be detected. This has been achieved by presence of isolated abnormal expiratory airflow limitation at low lung volumes on the maximal expiratory flow volume curves. This includes abnormal expiratory airflow at 75% and 80% expired lung volume. Current investigators believe investigators will be able to detect unsuspected small airways intrinsic obstruction, and peripheral airway bronchiectasis proven by lung CT, in patients with cystic fibrosis despite presence of pre bronchodilator normal routine spirometry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Years 至 40 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heterozygote or homozygote patients with cystic fibrosis with normal routine pre bronchodilator spirometry including normal FEV1(L), FVC(L) and FEV1/FVC%.
排除标准
- •Heterozygote or homozygote patients with cystic fibrosis with ABNORMAL routine pre bronchodilator spirometry
结局指标
主要结局
Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis
时间窗: 5 years
Retrospective analysis of pre bronchodilator spirometry, and lung CT study to detect abnormal FEF75% in the presence of normal spirometry and FEF25-75. Detect isolated abnormal pre bronchodilator spirometry at 75%FVC
次要结局
未报告次要终点
