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临床试验/NCT02825654
NCT02825654Enrolling By Invitation不适用

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

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 6,200 人开始时间: 2018年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
6,200
试验地点
6
主要终点
Current forced expiratory volume in 1 second (FEV1)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Current forced expiratory volume in 1 second (FEV1)

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

An assessment of pulmonary function obtained through spirometry

次要结局

  • 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))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

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