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临床试验/NCT00603629
NCT00603629
已完成
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A Pilot Study Determining Mechanisms of Acute Asthma Exacerbations Through Detailed Molecular Analysis of Airway Secretions and Tissues

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 23 人2008年1月1日
适应症Asthma

概览

阶段
不适用
干预措施
I
疾病 / 适应症
Asthma
发起方
University of California, San Francisco
入组人数
23
试验地点
2
主要终点
gene expression in blood and airway secretions and tissues
状态
已完成
最后更新
昨天

概览

简要总结

The purpose of this study is to investigate mechanisms which cause acute asthma exacerbations by examining blood and airway secretions during an acute onset (sputum or tracheal aspirates). This pilot study is intended to uncover new mechanisms of asthma exacerbation and to generate hypotheses for future study. By collaborating with Genentech, we (scientists at UCSF) plan to incorporate the latest scientific findings into our work to discover and develop new treatments for asthma.

详细描述

Asthma is a common airway disease with persistent unmet needs in terms of treatment. Although many asthmatics enjoy good control of their disease by using regularly scheduled corticosteroid treatment, a significant minority do not achieve optimal control with steroids and suffer asthma exacerbations which can be severe and even fatal. Asthma pathophysiology is complex and involves multiple cell types and multiple signaling mechanisms. One approach to this complexity has been to study responses of isolated airway cells to experimental conditions which model asthmatic inflammation; another has been genetic manipulations of candidate mediators of asthma in inbred mice. These studies have yielded important insights about possible mechanisms of asthma in humans, but the relevance of these mechanisms to human disease has not always been proven, and it is possible that unsuspected mechanisms have not yet been revealed by these approaches. In the current study, we propose to collect samples of airway secretions and blood from asthmatic subjects when their asthma is uncontrolled and they are being treated in the hospital or emergency room. Our goal will be to identify abnormal gene expression profiles and protein concentration abnormalities in these biological fluids. We will then study them again 6-10 weeks later when their asthma is controlled. This study design will allow us to compare airway and blood biomarkers of asthma exacerbation during acute asthma and recovery. "

注册库
clinicaltrials.gov
开始日期
2008年1月1日
结束日期
2009年9月1日
最后更新
昨天
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

John V. Fahy

Professor in Residence

University of California, San Francisco

入排标准

入选标准

  • Male and female subjects aged 18 - 70 years
  • Medical history of asthma
  • Currently experiencing an acute exacerbation of asthma
  • Ability to provide informed consent or have a surrogate provide consent.
  • Ability to provide sputum.

排除标准

  • Cigarette smoking: Subjects must be non-smokers. Non-smokers are defined as subjects who have never smoked or who have not smoked for 1 year and have a total pack-year smoking history \< 10 packs.
  • Pregnant women.

研究组 & 干预措施

I

People with acute asthma in the Emergency department or inpatient settings

结局指标

主要结局

gene expression in blood and airway secretions and tissues

时间窗: 6 - 10 weeks

Comparison of gene expression in blood and airway secretions and tissues during acute asthma exacerbation to recovery

研究点 (2)

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