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

Chronic Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03241420
• Other study ID #: HS-2985
• Status: Active, not recruiting
• Start date: April 24, 2017
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lung Disease
• Lung Diseases

Intervention

Device:
• lung clearance index (LCI)
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.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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