Service and Health Among Deployed Veterans

Pulmonary Function Clinical Trial

— SHADE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02825654
• Other study ID #: 595
• Status: Enrolling by invitation
• Start date: March 8, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6200
• Est. completion date: December 31, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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 after October 1, 2001

Exclusion Criteria:

• Active duty at the time of recruitment

• Impaired decision making capacity

• No English language proficiency

• Prisoners

Related Conditions & MeSH terms

• Pulmonary Function

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington
United States	VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA	West Roxbury	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Harvard University, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Current forced vital capacity (FVC)	An assessment of pulmonary function obtained through spirometry	Outcome measured at time of in-person study visit (Day 1)
Secondary	Current FEV1/FVC ratio	An assessment of pulmonary function obtained through spirometry	Outcome measured at time of in-person study visit (Day 1)
Secondary	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.	Outcome measured at time of in-person study visit (Day 1)

External Links

•   Seattle Epidemiologic Research and Information Center
•   VA Cooperative Studies Program