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临床试验/NCT01508078
NCT01508078暂停不适用

Characterization of Adult Subjects for Asthmatic Research Studies

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 259 人开始时间: 2010年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
259
试验地点
1
主要终点
Airway inflammation

研究概览

简要总结

This study is designed to characterize subjects in terms of the nature and severity of their asthma and in terms of conditions that may alter the clinical expression of asthma. Some features will be obtained in all subjects. These include a medical history and baseline lung function tests. This characterization forms the basis for our database that facilitates research protocols.

详细描述

The purpose of this study is to generate a cohort of well-characterized asthmatic subjects as a resource for recruitment of asthmatic subjects and healthy controls in clinical studies and clinical trials in the UCSF Airway Clinical Research Center. The UCSF Airway Clinical Research Center (ACRC) conducts multiple clinical research studies in asthma funded by the NIH, foundations, and industry. We have a broad range of research interests, but we have specific interests in mechanism-oriented clinical studies and specific expertise in biospecimen collection, biobanking, and biospecimen analysis. Our model is to have multiple studies recruiting simultaneously, and this means that we need well-organized recruitment and database systems.

Additionally, we aim to characterize asthmatic subjects in multiple domains, including disease severity, airway inflammation subtypes, and mucus subtypes. Asthma is a heterogeneous disease in its clinical presentation and in its underlying cellular and molecular phenotypes. To explore cellular and molecular phenotypes of asthma, we will analyze induced sputum for cell types and gene expression, with a focus on Th2 inflammation pathways and innate and adaptive immune cells that drive Th2 inflammation. Detailed cellular analysis of sputum is possible but requires that multiple sputum samples be collected for processing in multiple different ways, including by cytocentrifugation, FACS analysis, and by formalin fixation and paraffin embedding of sputum cell pellets. We are also studying mucus phenotypes of asthma using methods of rheology, which needs to be done on fresh sputum.

研究设计

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

入排标准

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

入选标准

  • •Age 18 years and older

排除标准

  • •History of lung disease other than asthma
  • •An upper respiratory tract infection or an exacerbation of their asthma within the preceding 4-6 weeks.
  • •Persons who have smoked > 5 cigarettes per month and have a total pack-year smoking history > 10 packs.

研究组 & 干预措施

Asthmatics

Otherwise healthy asthmatic subjects

Healthy controls

Healthy individuals without evidence of pulmonary disease.

结局指标

主要结局

Airway inflammation

时间窗: Cross-sectional

We will measure various indicators of airway inflammation and compare them with various phenotypic characteristics.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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