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NCT Number: NCT03241420

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

lung clearance index (LCI)

Device

Determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of lung injury/small airways disease in adults with chronic lung conditions compared to health adults, adjusting for age, sex, and smoking status.

Primary outcomes

  1. Lung Clearance Index (LCI) technique can be used as a marker of small airways disease in adults with chronic lung conditions

    Time frame: Up to 12 months

    Average of three acceptable trials.

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Important dates

Study start
2017
Primary completion
2030
Study completion
2030
First posted
Aug 7, 2017
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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