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Cardiopulmonary Responses to Exposure to Ozone and Diesel Exhaust (DEPOZ)

2013年6月10日 更新者：Michael Madden、Environmental Protection Agency (EPA)

Cardiopulmonary Responses to Exposure to Ozone and Diesel Exhaust With Moderate Exercise in Healthy Adults

The US EPA Clean Air Multiyear research program is moving toward a multi-pollutant approach to the assessment of air pollution in response to recommendations by the NRC 2004 and the BOSC in 2005. Such an approach better reflects the complexity of real-world air pollution problems and parallels evolving scientific and regulatory considerations. Ozone (O3) and diesel exhaust (DE) generally are major and important components of ambient air pollution. This proposed study will address the agency's goals by investigating the cardiopulmonary health effects in healthy human subjects co-exposed to O3 and DE. The findings derived from these exposures will provide NCEA findings for risk assessments of O3 and DE, as well as the Office of Air and Radiation (includes OTAQ and OAQPS) with information relevant to possible modulation of PM-induced health effects and responses by a gaseous co-pollutant for potential standard setting. Additionally the findings will address the fundamental driving principle of the Clean Air Research strategy related to reduction of health due to air pollutant exposures.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Numerous epidemiological studies have demonstrated an association between acute and chronic exposure to air pollution and various adverse cardiopulmonary effects including mortality, respiratory tract infections, exacerbation of asthma symptoms, chronic bronchitis, ischemic heart disease, and stroke [1] and other health effects. Understanding the components responsible for these effects is difficult because ambient air pollution is a complex mixture of gases and particulate matter (PM). In this complex mixture of ambient air pollution, ozone (O3) and diesel exhaust (DE) are generally major and important components. Controlled exposure of volunteers to either pollutant have resulted in biological effects such as lung physiological changes. However it is not known if co-exposure to both pollutants, similar to polluted ambient air, can induce additive or synergistic effects. Additionally it is also uncertain if exposure to DE, or DE with O3, can alter a subsequent exposure to O3 similar to multiple day exposures that the general population receives. This study proposes to examine whether co-exposures to O3 and DE can induce additive or synergistic effects, and whether a previous DE exposure alters a response upon subsequent exposure to O3. The potential effects of O3 on cardiac electrophysiology are also not clear.

Approximately 15 healthy non-smoking volunteers between the ages of 18 and 55 will be exposed in a controlled manner to O3 (approximately mean concentration of 0.3 ppm over the 2 hr exposure period), or diesel exhaust (DE; ~300 µg/m3), or a combined O3 and DE exposure while undergoing moderate intermittent exercise at the EPA Human Studies Facility. A clean air exposure will serve as a control. Primary endpoints for evaluating health effects and surrogate responses are changes in lung function and heart rate variability. In addition, other cardiopulmonary and vascular biological endpoints will be measured, as well as markers of exposure and genetic markers of susceptibility.

研究类型

介入性

注册 (实际的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • North Carolina
      • Chapel Hill、North Carolina、美国、27514
        • US EPA Human Studies Facility

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy men and women between 18 and 55 years of age
  • Physical conditioning allowing intermittent, moderate exercise for 2 hours

  • Normal lung function:

    1. FVC > 75 % of that predicted for gender, ethnicity, age and height.
    2. FEV1 > 75 % of that predicted for gender, ethnicity, age and height.
    3. FEV1/FVC ratio > 75 % of predicted values.
  • Oxygen saturation > 96 %.

Exclusion Criteria:

  • A history of acute and chronic cardiovascular disease, chronic respiratory disease, diabetes, rheumatologic diseases, immunodeficiency state, and acute respiratory illness within 4 weeks.
  • Subjects who are asthmatic or have a history of asthma.
  • Allergic to chemical vapors or gases.
  • Any allergic symptoms during the time of participation in the study
  • Female subjects who are currently pregnant, attempting to become pregnant, or breastfeeding
  • Subjects unwilling or unable to stop taking vitamin C or E or medications which may impact the results of the ozone challenge (such as, systemic steroids and beta blockers) at least 2 weeks prior to the study and for the duration of the study. Medications not specifically mentioned here may be reviewed by the investigators prior to a subject's inclusion in the study.
  • Current and past smokers within 1 year.
  • Uncontrolled hypertension (> 150 systolic, > 90 diastolic).
  • Subjects who do not understand or speak English
  • Subjects unable to perform the moderately active exercise required for the study.
  • Subjects with a history of skin allergies to adhesives used in securing heart rate monitor electrodes.
  • Unspecified diseases or conditions, which in the judgment of the investigator might influence the responses to the exposures, will be a basis for exclusion.
  • Subjects unwilling to stop taking over-the-counter pain medications such as aspirin, Advil, Aleve or other non-steroidal anti-inflammatory medications ("NSAIDS") for 48 hr prior to the exposures and post-exposure visits.
  • Subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms))

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Filtered air exposure
2 hr exposure to clean, filtered air with intermittent exercise
其他：ozone
Exposure to 300 ppb ozone with intermittent exercise about 20 hr after exposure to each arm (ie, either air, ozone, diesel exhaust, or ozone combined with diesel exhaust)
其他名称：
  • cas # 10028-15-6
  • trioxygen
实验性的：Ozone
2 hr exposure to 300 ppb ozone with intermittent exercise
其他：ozone
Exposure to 300 ppb ozone with intermittent exercise about 20 hr after exposure to each arm (ie, either air, ozone, diesel exhaust, or ozone combined with diesel exhaust)
其他名称：
  • cas # 10028-15-6
  • trioxygen
实验性的：Diesel Exhaust, No ozone
2 hr exposure to whole diesel exhaust (300 ug/m3; gases + particles) with intermittent exercise; no ozone
其他：ozone
Exposure to 300 ppb ozone with intermittent exercise about 20 hr after exposure to each arm (ie, either air, ozone, diesel exhaust, or ozone combined with diesel exhaust)
其他名称：
  • cas # 10028-15-6
  • trioxygen
实验性的：Ozone + Diesel Exhaust
2 hr exposure to a combination of 300 ppb ozone an 300 ug/m3 whole diesel exhaust with intermittent exercise
其他：ozone
Exposure to 300 ppb ozone with intermittent exercise about 20 hr after exposure to each arm (ie, either air, ozone, diesel exhaust, or ozone combined with diesel exhaust)
其他名称：
  • cas # 10028-15-6
  • trioxygen

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Lung Function Decrement
大体时间：Immediately post to 24 hr post exposure
Lung function decrements are typically expressed as changes in FEV1 and FVC. Measurements are made pre-exposure (defined as baseline, immediately post exposure, 1-4 hr post exposure, and 24 hr post exposure (follow up).
Immediately post to 24 hr post exposure

次要结果测量

结果测量
大体时间
Heart rate variability
大体时间：immediately post to 24 hr post exposure
immediately post to 24 hr post exposure

其他结果措施

结果测量
措施说明
大体时间
plasma cytokine levels
大体时间：immediately post to 24 hr post exposur
Inflammation markers such as interleukin 8
immediately post to 24 hr post exposur

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Environmental Protection Agency (EPA)

调查人员

  • 首席研究员：Michael Madden, PhD、Environmental Protection Agency (EPA)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年8月1日

初级完成 (实际的)

2012年4月1日

研究完成 (实际的)

2013年1月1日

研究注册日期

首次提交

2013年6月7日

首先提交符合 QC 标准的

2013年6月10日

首次发布 (估计)

2013年6月11日

研究记录更新

最后更新发布 (估计)

2013年6月11日

上次提交的符合 QC 标准的更新

2013年6月10日

最后验证

2013年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EPA 09-1344

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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