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

NCT03241420 | Active Not Recruiting

• 1 other identifier: HS-2985
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lung Disease

Outcome Measures

Primary Outcomes (1)

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

  Average of three acceptable trials.

  Up to 12 months

Study Arms (2)

Chronic Lung conditions

Study participation will consist of one visit: Informed consent, complete both Lung Clearance Index (LCI) testing and spirometry.

Device: lung clearance index (LCI)

Healthy control group

Study participation will consist of one visit: Informed consent, brief questionnaire, LCI testing and spirometry.

Device: lung clearance index (LCI)

Interventions

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.

Chronic Lung conditions; Healthy control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Symptomatic military deployers with deployment-related lung disease seen at National Jewish Health and healthy controls subjects.

You may qualify if:

• 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

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (2)

• Zell-Baran LM, Krefft SD, Moore CM, Wolff J, Meehan R, Rose CS. Multiple breath washout: A noninvasive tool for identifying lung disease in symptomatic military deployers. Respir Med. 2021 Jan;176:106281. doi: 10.1016/j.rmed.2020.106281. Epub 2020 Dec 5.

  PMID: 33340829 BACKGROUND

• Zell-Baran LM, Krefft SD, Moore CM, Wolff J, Meehan R, Rose CS. Multiple breath washout test data for healthy controls. Data Brief. 2020 Dec 10;34:106641. doi: 10.1016/j.dib.2020.106641. eCollection 2021 Feb.

  PMID: 33365370 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: August 7, 2017
• Study Start: April 24, 2017
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)