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

Active, not recruiting

• Conditions: Chronic Lung Disease
• Interventions: Device: lung clearance index (LCI)

• Registration Number: NCT03241420
• Lead Sponsor: National Jewish Health

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-04-24
• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Lung Clearance Index (LCI) technique can be used as a marker of small airways disease in adults with chronic lung conditions	Up to 12 months	Average of three acceptable trials.

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States