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

National Jewish Health

Status: Completed

Conditions: Dyspnea; Bronchiolitis; Pneumonitis

Treatments: Other: Lung clearance index (LCI)

Study type: Observational

Funder types: Other

Identifiers

NCT03012958

HS-2851

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

73 participants in 2 patient groups

Health control group

Description:

Who are 18 years or older, have no history of pre-existing lung disease, and report no respiratory illness in the four weeks preceding enrollment. This study consist of one visit: If the potential subject meets the Inclusion and exclusion then they will have the LCI testing.

Treatment:

Other: Lung clearance index (LCI)

Deployment-related lung disease

Description:

Defined as the presence of unexplained chest symptoms in a deployer who, on surgical lung biopsy is found to have bronchiolitis or granulomatous pneumonitis without other known causes. This study consist of one visit: If the potential subject meets the Inclusion and exclusion then they will have the LCI testing.

Treatment:

Other: Lung clearance index (LCI)