跳至主要内容
临床试验/NCT00595114
NCT00595114已完成不适用

Ancillary Study of Oxidative Stress and Anti-Inflammatory Lipids in Airway Disease in the MIA (ACRN) and LEUKO (CCRN) Trials

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
8-isoprostane Levels as Biochemical Markers for Nonenzymatic Oxidative Stress in Asthma

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases in which people experience long-term inflammation of the lungs. Exacerbations, or prolonged worsening of symptoms, of asthma and COPD are often life-threatening and can lead to frequent need for hospitalization. Even with the proper use of bronchodilators, corticosteroids, and other currently available medications, clinical responses among people with COPD and asthma are variable. There remains a significant unmet clinical need for new therapeutic approaches and insights, including the identification of biomarkers to accurately assess the presence of airway infection and intensity of airway inflammation. This study will investigate potential natural biological causes and new biomarkers for increased susceptibility to persistent airway infection in asthma and COPD.

详细描述

COPD and asthma are chronic lung diseases that result in impaired air flow in the lungs, often causing coughing, wheezing, and shortness of breath. In uncontrolled COPD and asthma, people may experience a rapid worsening of symptoms, which may include fever, difficulty breathing, and chest pain. These exacerbations are the most serious expression of asthma and COPD and are usually caused by lung infections or air allergens. However, the biological basis for susceptibility to airway infection and inflammation is not well understood. Increased oxidative stress within the airways has been linked to several airway diseases. This increase in oxidative stress may reduce production of key fatty acid anti-inflammatory mediators. In turn, this may disrupt the airway's natural immune response mechanisms, making the airways more vulnerable to infection or inflammation during COPD and asthma exacerbations. This ancillary study will determine whether susceptibility to persistent airway infection in asthma and COPD stems from increased oxidative stress that impairs the natural formation of protective fatty acid mediators.

This ancillary study will use data biological samples, including blood and sputum, from participants currently enrolled in the Macrolides in Asthma (MIA; NCT00318708) and the Antileukotriene Therapy for COPD Exacerbations (KIA; NCT01097694). Biological samples will undergo fatty acid mediator analysis and RNA isolation. There will be no study visits for this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No change from the MIA and LEUKO trials

排除标准

  • No change from the MIA and LEUKO trials

结局指标

主要结局

8-isoprostane Levels as Biochemical Markers for Nonenzymatic Oxidative Stress in Asthma

时间窗: Measured at completion of sample analysis

8-isoprostane levels in sputum

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruce D. Levy

Principal Investigator

Brigham and Women's Hospital

研究点 (1)

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