NCT02825654

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,200

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2018Jun 2029

First Submitted

Initial submission to the registry

June 21, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 8, 2018

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

9.3 years

First QC Date

June 21, 2016

Last Update Submit

November 4, 2025

Conditions

Pulmonary Function

Keywords

PulmonaryLungMilitary and environmental exposuresEpidemiologicObservationalInterview or questionnaireDeployment relatedEnduring FreedomIraqi Freedom

Outcome Measures

Primary Outcomes (1)

  • Current forced expiratory volume in 1 second (FEV1)

    An assessment of pulmonary function obtained through spirometry

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

Secondary Outcomes (3)

  • Current forced vital capacity (FVC)

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

  • Current FEV1/FVC ratio

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

  • Pharmaceutically-treated asthma

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

Study Arms (1)

Post-9/11 Gulf War Era Veterans

Military personnel who deployed to Central Asia, Southwest Asia, and Africa during the Post-9/11 Gulf War Era

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

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

West Roxbury, Massachusetts, 02132, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

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

Seattle, Washington, 98108-1532, United States

Location

Related Publications (4)

  • 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.

    PMID: 37968126BACKGROUND

  • 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.

    PMID: 38536226BACKGROUND

  • 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.

    PMID: 39659739BACKGROUND

  • 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.

    PMID: 40690216BACKGROUND

Related Links

Study Officials

  • Eric Garshick, MD

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

    STUDY CHAIR

  • Paul D Blanc, MD MSPH

    San Francisco VA Medical Center, San Francisco, CA

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
50 Years
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

July 7, 2016

Study Start

March 8, 2018

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2029

Last Updated

November 6, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

All collected data may be shared dependent upon data safeguards and IRB approvals.

Shared Documents
ICF
Time Frame
Data will be made available for sharing 1 year after the publication of the last manuscript addressing the primary aims of the study.
Access Criteria
The VA Cooperative Studies Program (CSP) has a program for sharing CSP study data: Integrated Veteran Epidemiologic Study Data Resource (INVESTD-R). The INVESTD-R website is where information is provided on CSP studies with data that can be shared for secondary analyses or to support new data collection from study members who consented to be recontacted. Data will be shared with qualifying investigators at bona fide research institutions.
More information

Locations

US(6)