Clinical trial NCT03012958: Utility of Lung Clearance Index Score as a Noninvasive Marker of Deployment Lung Disease
Official title: Utility of Lung Clearance Index Score as a Noninvasive Marker of Deployment Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis
Pneumonitis
Dyspnea
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic military deployers with deployment-related lung disease seen at National Jewish Health and healthy controls subjects.

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.

Eligibility criteria: 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

Primary outcomes:
measure: LCI parameters in symptomatic deployers compared to normal adults to determine whether LCI is an early marker of lung injury.
timeFrame: Up to 24 months
Secondary outcomes:
measure: Correlation between LCI score and the clinical characteristics of the population of deployers.
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References:
citation: 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.
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.