Urban Environment and Childhood Asthma (URECA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 560
- 试验地点
- 4
- 主要终点
- Development of wheezing
研究概览
简要总结
Minority children who grow up in poor urban neighborhoods have the highest rates of asthma, and also experience greater morbidity from acute exacerbations of this disease. The aim of this study is to further identify environmental factors unique to the inner city that affect immune development and the expression of wheezing, atopy and asthma for purposes of identifying new strategies for asthma prevention.
详细描述
The purpose of this study is to determine the way environmental factors (like the components of inner-city household dust) affect immune system development and symptoms of asthma in inner city children. The study is divided into five periods, as the subjects age from birth to 17 years old. Each age bracket will explore different objectives and endpoints.
Study Objectives/Hypotheses:
- Subjects age 0 to 3 years old:
- Environmental factors in the inner city adversely influence the development of the immune system to promote cytokine dysregulation, allergy, and recurrent wheezing by age 3.
- Children who have had a viral lower respiratory infection and have developed cytokine dysregulation by age 3 are at increased risk for the development of asthma by age 6.
- Subjects age 4 to 7 years old:
- There is a unique pattern of immune development that is driven by specific urban exposures in early life, and this pattern of immune development is characterized by: 1) impairment of antiviral responses and 2) accentuation of Th2-like responses (e.g. cockroach-specific Interleukin-13(IL-13)). The clinical effects of these changes in immune development are frequent virus-induced wheezing and allergic sensitization by 3-4 years of age, and these characteristics synergistically increase the risk of asthma at age 7 years.
- Subjects age 7 to 10 years old:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Development of wheezing
时间窗: 0 to 3 years of age
Establish in inner city children the immunologic causes for the development of recurrent wheezing.
Correlation of Immunologic Factors and Development of Asthma
时间窗: by 7 years of age
Establish, in this cohort of inner-city children, the immunologic causes for the development of asthma at age 7
Occurrence of Specific Phenotypes of Asthma
时间窗: up to 17 years of age
Further define asthma phenotypes based on the findings in Inner-city Asthma Consortium-19 (ICAC-19) (Asthma Phenotypes in the Inner City (APIC), ClinicalTrials.gov Identifier NCT01383941).
Correlation of Risk Factors to Rapidly Evolving Asthma Phenotypes
时间窗: up to 10 years of age
Fully define the rapidly evolving asthma phenotypes and further delineate the role of risk factors related to environmental exposure (e.g.; house dust levels found through home inspection), immune development, lung growth on the natural history of asthma and allergic diseases in urban minority children
Incidence of Asthma
时间窗: up to 17 years of age
Number of participants with the incidence (development) of asthma
次要结局
未报告次要终点