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

This study is currently recruiting participants.
Verified January 2017 by Jennifer Brandorff, National Jewish Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT03012958
First Posted: January 6, 2017
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health
  Purpose
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.

Condition Intervention Phase
Bronchiolitis Pneumonitis Dyspnea Other: Lung clearance index (LCI) Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Utility of Lung Clearance Index Score as a Noninvasive Marker of Deployment Lung Disease

Resource links provided by NLM:


Further study details as provided by Jennifer Brandorff, National Jewish Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Correlation between LCI score and the clinical characteristics of the population of deployers. [ Time Frame: Up to 24 months ]

Estimated Enrollment: 400
Study Start Date: July 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Health control group

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.

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.
Experimental: Deployment-related lung disease

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.

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.

Detailed Description:

The healthy control group will comprise 20 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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012958


Contacts
Contact: Jenna Marcotte, BS 303-398-1418 marcottej@njhealth.org
Contact: Cecile Rose, MD 303-398-1867 rosec@njhealth.org

Locations
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Jenna Marcotte, BS    303-398-1418    marcottej@njhealth.org   
Sponsors and Collaborators
National Jewish Health
  More Information

Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health
ClinicalTrials.gov Identifier: NCT03012958     History of Changes
Other Study ID Numbers: HS-2851
First Submitted: January 3, 2017
First Posted: January 6, 2017
Last Update Posted: January 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Lung Diseases
Bronchiolitis
Dyspnea
Pneumonia
Respiratory Tract Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms


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