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Pulmonary FunctionSHADENCT02825654

Service and Health Among Deployed Veterans

An observational study of Pulmonary Function, run by VA Office of Research and Development at 6 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The purpose of the study is to better understand the health, including lung health, of Veterans who deployed in support of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), or Operation New Dawn (OND) and other deployments following these Operations. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Pulmonary Function
How many people
6,200 participants
Where
6 sitesUnited States
Study dates
8 Mar 2018to 30 Jun 2029
How long will I take part?
50 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The sampling frame for the study is military personnel identified from Department of Defense (DoD) Defense Manpower Data Center (DMDC) records who meet the inclusion and exclusion criteria. From among those Veterans who meet study eligibility, the investigators will identify a sample of Veterans living in the catchment area of the participating VA medical centers for recruitment. The study is not open to volunteers; Veterans must be selected from the sampling frame to participate.

Who may be able to join

  • Served during the Post-9/11 Gulf War Era in a service branch that had land-based deployments (Air Force, Army, and Marine Corps)
  • Deployed to Afghanistan, Kyrgyzstan, Iraq, Kuwait, Qatar, United Arab Emirates, or Djibouti between October 1, 2001 and August 31, 2021

Who cannot join

  • Active duty at the time of recruitment
  • Impaired decision making capacity
  • No English language proficiency
  • Prisoners

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

United States6 sites

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030-4211

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417-2309

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161-0002

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532

  • VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA

    West Roxbury, Massachusetts, 02132

Other trials in United States

About this study

Official title: CSP #595 - Pulmonary Health and Deployment to Southwest Asia and Afghanistan

The purpose of the study is to better understand the health, including lung health, of Veterans who deployed in support of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), or Operation New Dawn (OND) and other deployments following these Operations.

Read the detailed description

The aim of the study is to characterize the impact of deployment-related pollution exposures during the Post-9/11 Gulf War Era on current respiratory health using objectively ascertained and standardized physiologic and epidemiologic measures. The primary objective in support of this aim is to assess the association of cumulative exposure to PM2.5 during deployments to the U.S. bases and other locations in Central Asia (Afghanistan and Kyrgyzstan), Southwest Asia (Iraq, Kuwait, Qatar, and United Arab Emirates) and Africa (Djibouti) with current measures of pulmonary function. Secondary objectives in support of the aim will examine the association of cumulative exposure to PM2.5 during deployments with the clinical outcome of medically-treated asthma. The investigators will also explore the impact of deployment duration on both pulmonary function and asthma.

This study will execute 4 distinct efforts to meet the study objectives: (1) enroll a study cohort of up to 6,200 Veterans who live within the catchment area of 6 VA recruitment sites, conduct an in-person assessment of pulmonary function, and collect data on key covariates; (2) create a spatial-temporal exposure grid of environmental PM2.5 levels averaged per week per 1 square kilometer at locations where military personnel served; (3) link each individual's location and duration (spatial-temporal) history during deployed and non-deployed times with averaged PM exposures during each of these time periods; and (4) conduct association analyses to test hypotheses of deployment-related cumulative PM2.5 exposure and current respiratory health by combining exposure data with data collected from the cohort members and from their military records.

Keywords
Pulmonary, Lung, Military and environmental exposures, Epidemiologic, Observational, Interview or questionnaire, Deployment related, Enduring Freedom, Iraqi Freedom

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02825654
Study groupRoleWhat they receive
Post-9/11 Gulf War Era VeteransMilitary personnel who deployed to Central Asia, Southwest Asia, and Africa during the Post-9/11 Gulf War Era

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Current forced expiratory volume in 1 second (FEV1)

    An assessment of pulmonary function obtained through spirometry

    Measured: Outcome measured at time of in-person study visit (Day 1)

Secondary outcomes (3)

  1. Current forced vital capacity (FVC)

    An assessment of pulmonary function obtained through spirometry

    Measured: Outcome measured at time of in-person study visit (Day 1)

  2. Current FEV1/FVC ratio

    An assessment of pulmonary function obtained through spirometry

    Measured: Outcome measured at time of in-person study visit (Day 1)

  3. Pharmaceutically-treated asthma

    Based on medication inventory, the investigators will classify medically-treated asthma therapy into mild, moderate, and severe based on the intensity of asthma therapy as suggested by the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2015.

    Measured: Outcome measured at time of in-person study visit (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2016 (estimated)
  2. Study start8 Mar 2018
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
6,200 participants (estimated)
Target duration
50 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02825654
Sponsor's protocol ID
595
Acronym
SHADE
Status last verified
Oct 2026
First submitted
21 Jun 2016
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data may be shared dependent upon data safeguards and IRB approvals.

Publications

  • Garshick E, Redlich CA, Korpak A, Timmons AK, Smith NL, Nakayama K, Baird CP, Ciminera P, Kheradmand F, Fan VS, Hart JE, Koutrakis P, Kuschner W, Ioachimescu O, Jerrett M, Montgrain PR, Proctor SP, Wan ES, Wendt CH, Wongtrakool C, Blanc PD. Chronic respiratory symptoms following deployment-related occupational and environmental exposures among US veterans. Occup Environ Med. 2024 Feb 2;81(2):59-65. doi: 10.1136/oemed-2023-109146.

    PubMed 37968126

  • Maccarone JR, Sterns OR, Timmons A, Korpak AM, Smith NL, Nakayama KS, Baird CP, Ciminera P, Kheradmand F, Fan VS, Hart JE, Koutrakis P, Jerrett M, Kuschner WG, Ioachimescu OC, Montgrain PR, Proctor SP, Redlich CA, Wendt CH, Blanc PD, Garshick E, Wan ES. Deployment-related Cigarette Smoking Behaviors and Pulmonary Function Among U.S. Veterans. Mil Med. 2024 Aug 30;189(9-10):2030-2038. doi: 10.1093/milmed/usae049.

    PubMed 38536226

  • Maccarone J, Redlich CA, Timmons A, Korpak AM, Smith NL, Nakayama KS, Baird CP, Ciminera P, Kheradmand F, Fan VS, Hart JE, Koutrakis P, Kuschner WG, Ioachimescu OC, Jerrett M, Montgrain PR, Proctor SP, Wendt CH, Wongtrakool C, Wan ES, Blanc PD, Garshick E. Sinusitis and rhinitis among US veterans deployed to Southwest Asia and Afghanistan after September 11, 2001. J Allergy Clin Immunol Glob. 2024 Oct 31;4(1):100367. doi: 10.1016/j.jacig.2024.100367. eCollection 2025 Feb.

    PubMed 39659739

  • Hosseini R, Garshick E, Slade MD, Timmons A, Korpak AM, Smith NL, Nakayama KS, Baird CP, Ciminera P, Kheradmand F, Fan VS, Hart JE, Koutrakis P, Kuschner WG, Ioachimescu OC, Jerrett M, Montgrain PR, Proctor SP, Wendt CH, Wongtrakool C, Wan ES, Blanc PD, Redlich CA. Military Inhalational Exposures Outside the Theater of Conflict and Chronic Respiratory Symptoms. JAMA Netw Open. 2025 Jul 1;8(7):e2522080. doi: 10.1001/jamanetworkopen.2025.22080.

    PubMed 40690216

  • Mohazzab-Hosseinian S, Redlich CA, Korpak AM, Timmons AKI, Smith NL, Nakayama KS, Kheradmand F, Fan VS, Jerrett M, Montgrain PR, Wendt CH, Kuschner WG, Wan ES, Garshick E, Blanc PD. Civilian Occupational Exposure to Vapors, Gas, Dust, or Fumes and Respiratory Health Among United States Military Veterans. Am J Ind Med. 2026 Jul;69(7):503-511. doi: 10.1002/ajim.70083. Epub 2026 Apr 24.

    PubMed 42028841

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Function, run by VA Office of Research and Development at 6 sites 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Current forced expiratory volume in 1 second (FEV1) (time frame: Outcome measured at time of in-person study visit (Day 1)). 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 NCT02825654, which also lists 5 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 19 Oct 2026.

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