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临床试验/NCT03241420
NCT03241420进行中(未招募)不适用

Utility of Lung Clearance Index Score as a Noninvasive Marker of Small Airways Disease

National Jewish Health1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年4月24日最近更新:
适应症
干预措施

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cecile Rose Professor of Medicine

PI

National Jewish Health

研究点 (1)

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