Utility of Lung Clearance Index Score as a Noninvasive Marker of Small Airways Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Lung Clearance Index (LCI) technique can be used as a marker of small airways disease in adults with chronic lung conditions
研究概览
简要总结
To determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of small airways disease in adults with chronic lung conditions compared to healthy adults, adjusting for age, sex and smoking status.
详细描述
Target Population and Enrollment. The study will recruit and consent 300 patients from our Occupational Medicine and Interstitial Lung/Rheumatology Clinics at National Jewish Health who have been referred for evaluation of chronic lung conditions. The healthy control group will comprise 300 volunteers who are at least 18 years of age, have no history of pre-existing lung disease, and report no respiratory illness in the four weeks preceding enrollment. Inclusion criteria for the group with chronic lung disease will include physician diagnosis of a chronic lung condition (e.g. bronchiolitis, pulmonary fibrosis, asthma, coal mine dust lung disease, asbestosis), and age ≥18 years. Exclusion criteria will include recent myocardial infarction, stroke, eye surgery, chest/abdominal surgery (within past month), known thoracic, aortic, or cerebral aneurysm, or uncontrolled hypertension. Study participation will consist of one visit that will last between 90-120 minutes. The chronic lung disease group will fill out the informed consent and complete both LCI testing and spirometry. The healthy control group will complete informed consent, a brief questionnaire, LCI testing, and spirometry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •physician diagnosis of a chronic lung condition (e.g. bronchiolitis, pulmonary fibrosis, asthma, coal mine dust lung disease, asbestosis), and age ≥18 years.
- •The healthy control group will comprise 300 volunteers who are at least 18 years of age, have no history of pre-existing lung disease, and report no respiratory illness in the four weeks preceding enrollment
排除标准
- •Exclusion criteria will include recent myocardial infarction, stroke, eye surgery, chest/abdominal surgery (within past month), known thoracic, aortic, or cerebral aneurysm, or uncontrolled hypertension.
研究组 & 干预措施
Chronic Lung conditions
Study participation will consist of one visit: Informed consent, complete both Lung Clearance Index (LCI) testing and spirometry.
干预措施: lung clearance index (LCI) (Device)
Healthy control group
Study participation will consist of one visit: Informed consent, brief questionnaire, LCI testing and spirometry.
干预措施: lung clearance index (LCI) (Device)
结局指标
主要结局
Lung Clearance Index (LCI) technique can be used as a marker of small airways disease in adults with chronic lung conditions
时间窗: Up to 12 months
Average of three acceptable trials.
次要结局
未报告次要终点
研究者
Cecile Rose Professor of Medicine
PI
National Jewish Health
