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

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National Jewish Health

Status

Active, not recruiting

Conditions

Chronic Lung Disease

Treatments

Device: lung clearance index (LCI)

Study type

Observational

Funder types

Other

Identifiers

NCT03241420
HS-2985

Details and patient eligibility

About

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.

Full description

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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

600 participants in 2 patient groups

Chronic Lung conditions
Description:
Study participation will consist of one visit: Informed consent, complete both Lung Clearance Index (LCI) testing and spirometry.
Treatment:
Device: lung clearance index (LCI)
Healthy control group
Description:
Study participation will consist of one visit: Informed consent, brief questionnaire, LCI testing and spirometry.
Treatment:
Device: lung clearance index (LCI)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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