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OpenTrials
Completed

NCT Number: NCT03012958

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung clearance index (LCI)

Other

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.

Primary outcomes

  1. LCI parameters in symptomatic deployers compared to normal adults to determine whether LCI is an early marker of lung injury.

    Time frame: Up to 24 months

    Average of three acceptable trials

Secondary outcomes

  1. Correlation between LCI score and the clinical characteristics of the population of deployers.

    Time frame: Up to 24 months

    Comparison with pulmonary function testing and other clinical measures

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Acronym: LCI

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2017
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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