Utility of Lung Clearance Index Score as a Noninvasive Marker of Deployment Lung Disease
- Conditions
- PneumonitisDyspneaBronchiolitis
- Interventions
- Other: Lung clearance index (LCI)
- Registration Number
- NCT03012958
- Lead Sponsor
- National Jewish Health
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Health control group Lung clearance index (LCI) 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. Deployment-related lung disease Lung clearance index (LCI) 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.
- Primary Outcome Measures
Name Time Method LCI parameters in symptomatic deployers compared to normal adults to determine whether LCI is an early marker of lung injury. Up to 24 months Average of three acceptable trials
- Secondary Outcome Measures
Name Time Method Correlation between LCI score and the clinical characteristics of the population of deployers. Up to 24 months Comparison with pulmonary function testing and other clinical measures
Trial Locations
- Locations (1)
National Jewish Health
🇺🇸Denver, Colorado, United States