BronchiolitisLCINCT03012958
Utility of Lung Clearance Index Score as a Noninvasive Marker of Deployment Lung Disease
An observational study of Bronchiolitis and Pneumonitis, run by National Jewish Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis, Pneumonitis, Dyspnea
- What is being tested?
- Lung clearance index (LCI)
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Symptomatic military deployers with deployment-related lung disease seen at National Jewish Health and healthy controls subjects.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bronchiolitis, Pneumonitis, Dyspnea
- Being tested
- Lung clearance index (LCI)
- Medical subject headings
- Bronchiolitis, Pneumonia, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lung clearance index (LCI) | |
| 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. Receives: Other: Lung clearance index (LCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LCI parameters in symptomatic deployers compared to normal adults to determine whether LCI is an early marker of lung injury.
Average of three acceptable trials
Measured: Up to 24 months
Secondary outcomes (1)
Correlation between LCI score and the clinical characteristics of the population of deployers.
Comparison with pulmonary function testing and other clinical measures
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJul 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecile Rose Professor of Medicine, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012958
- Sponsor's protocol ID
- HS-2851
- Acronym
- LCI
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2017
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28665837Zell-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.
PubMed 33365370
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Lung Clearance Index Score as a Noninvasive Marker of Deployment Lung Disease
- ClinicalTrials.gov ID
- NCT03012958
- Acronym / sponsor ID
- LCI / HS-2851
- Conditions
- Bronchiolitis, Pneumonitis, Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health control group | – | Other: 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 | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic military deployers with deployment-related lung disease seen at National Jewish Health and healthy controls subjects.
Key inclusion criteria (7 listed)
- 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.
- no history of pre-existing lung disease
- no respiratory illness in the four weeks preceding enrollment
Key exclusion criteria (8 listed)
- 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
- pre-existing lung disease
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Deployment-related lung disease, Health control group |
Primary outcome
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
1 secondary outcome
Correlation between LCI score and the clinical characteristics of the population of deployers.
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Background: PubMed 28665837Krefft 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.
- Background: PubMed 33365370Zell-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis and Pneumonitis, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03012958, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.