Utility of Lung Clearance Index Score as a Noninvasive Marker of Deployment Lung Disease

Dyspnea Clinical Trial

— LCI  

Official title:

Utility of Lung Clearance Index Score as a Noninvasive Marker of Deployment Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012958
• Other study ID #: HS-2851
• Status: Completed
• Start date: July 2014
• Est. completion date: May 2018

Study information

• Verified date: January 2021
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to learn more about new noninvasive ways of detecting lung disease in US Military personnel and people who worked as contractors during military operations in Iraq and Afghanistan. This study is looking at conducting a type of breathing test called the lung clearance index (LCI) test which is being investigated as a potential noninvasive way to detect the type of lung disease that may be seen in symptomatic deployers retuning from Iraq and Afghanistan.

Description:

The healthy control group will comprise 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.

The symptomatic deployers who have undergone lung biopsy and meet the case definition for deployment-related lung disease. A case of deployment-related lung disease is defined as the presence of unexplained chest symptoms in a deployer who, on a surgical lung biopsy, is found to have bronchiolitis or granulomatous pneumonitis without other known cause.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For the deployer group:

• presence of respiratory symptoms (cough, chest tightness, wheezing, shortness of breath or decreased exercise tolerance) following deployment

• history of deployment for Operation Iraqi Freedom, Operation Enduring Freedom or Operation New Dawn for greater than or equal to 6 weeks as either military personnel or a civilian contractor

• prior VATS biopsy-proven histologic abnormalities of small airways disease.

For the control group:

• no history of pre-existing lung disease

• no respiratory illness in the four weeks preceding enrollment

Exclusion Criteria:

For the deployer group:

• If on clinical evaluation they were found to have asthma, vocal cord dysfunction or other explanations for their respiratory symptoms and did not need to undergo surgical lung biopsy for diagnosis.

• unable to provide informed consent

• pregnant subjects

For the control group:

• pre-existing lung disease

• unable to provide informed consent

• pregnant subjects

Related Conditions & MeSH terms

• Bronchiolitis
• Dyspnea
• Lung Diseases
• Pneumonia
• Pneumonitis

Intervention

Other:
• Lung clearance index (LCI)
LCI is determined by the number of lung volume turnovers necessary to clear the lungs of an inert tracer gas such as nitrogen that is inhaled at the beginning of the test. The LCI is calculated by determining the cumulative expired volume (CEV) and then dividing the CEV by the functional residual capacity. Values of less than7.0 indicate normal values while an LCI greater than 7.0 is associated with heterogeneity in ventilation and distal airway abnormalities. The ability to detect peripheral airway disease may make LCI a better modality for detecting distal airways abnormalities seen on lung histopathology but often missed on traditional pulmonary function testing.

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)

Krefft SD, Strand M, Smith J, Stroup C, Meehan R, Rose C. Utility of Lung Clearance Index Testing as a Noninvasive Marker of Deployment-related Lung Disease. J Occup Environ Med. 2017 Aug;59(8):707-711. doi: 10.1097/JOM.0000000000001058. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LCI parameters in symptomatic deployers compared to normal adults to determine whether LCI is an early marker of lung injury.	Average of three acceptable trials	Up to 24 months
Secondary	Correlation between LCI score and the clinical characteristics of the population of deployers.	Comparison with pulmonary function testing and other clinical measures	Up to 24 months