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Childhood Asthma Reduction Study

Background:

- Cockroach allergies are an important risk factor for asthma in inner-city households, especially in children. A new method for killing cockroaches may help children who live in households that have high numbers of cockroaches. Because most public health treatments target more than just cockroaches, this method could lower the costs of treating childhood allergies and asthma by focusing on the most likely source of the allergy.

Objectives:

- To test a new cockroach-killing method designed to reduce asthma in children exposed to cockroaches.

Eligibility:

  • Children 5 to 14 years of age who have moderate to severe asthma.
  • Children must live in a household that has a high number of cockroaches.

Design:

  • Participants will be screened with a phone call and an initial home visit.
  • Study doctors will place cockroach traps, and return after 3 days to check the number of roaches caught and killed. Dust samples will be collected from the house.
  • Participants will have blood and lung function tests, and will be tested for allergies (including cockroach allergies).
  • Some households will be treated for cockroaches at regular intervals, or more frequently if required by the study doctors.
  • Participants will have regular checkup visits in their homes at months 1, 3, 6, 9, and 12 and short phone call interviews at months 2, 4, 6, 8 and 10 to study their asthma symptoms. The home visits will also check the cockroach levels in the house.

研究概览

地位

撤销

条件

详细说明

Asthma is the most prevalent chronic childhood condition and is the most frequent cause of hospitalization among children. There are about 6.7 million children in the U.S. who currently have asthma, and nearly two of every three of these children had at least one attack in the past 12 months. Evidence suggests that exposure to cockroach allergen might be the most important risk factor for asthma in inner-city households. An environmental intervention targeting only cockroach allergen could potentially provide cost savings in a public health program over high cost multi-component interventions, if it could be shown to reduce asthma morbidity.

The primary objective of the Childhood Asthma REduction Study (CARES) is to evaluate the effectiveness of a novel cockroach eradication method, shown in prior studies to drastically decrease cockroach allergen levels, in reducing asthma morbidity in children with moderate to severe asthma who are both allergic and exposed to cockroach allergen. Additionally, the study will characterize relationships between cockroach infestation and other environmental allergen exposures, and asthma morbidity, as well as consider dynamic relationships between cockroach counts and observed allergen reductions over time; and use study data to identify mechanisms such as cleaning behaviors that may influence those relationships.

These objectives will be addressed through a prospective, randomized controlled, multi-site intervention trial in which 414 eligible children age 5 to 14 years who live in households with a confirmed trap count of 30 or more cockroaches over a 3-day period, are randomly assigned to one of two treatment groups. Treatment will be implemented at multiple intervals in the homes of children assigned to the intervention group. Children in both the intervention and control groups will receive clinical evaluations for asthma, home assessments of allergen exposures, educational materials on allergen exposures and asthma, and information on study results. Following 12-months of active data collection, the extermination treatment will be made available to the homes of children in the control group. The target sample size is 372 participants completing the study, equally divided into the two arms. Home environmental assessments following the enrollment visit will take place at enrollment, 1, 3, 6, 9, and 12 months. Clinical assessments will also be conducted in the home at enrollment and the 12-month visit. Primary outcome data will be collected during scheduled follow up phone calls every two months.

研究类型

介入性

阶段

  • 不适用

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

5年 至 14年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

A child will be included in this study if the following criteria apply:

(Assessed during phone screening)

  • Aged 5 to 14 years of age
  • Physician diagnosis of asthma for at least one year prior to prescreening
  • Parent/guardian able and willing to provide consent; child able and willing to provide assent
  • Primary caretaker and child are able to speak English or Spanish
  • Moderate to severe asthma as defined by the child experiencing one of the following:

    • One overnight hospitalization for asthma within the past 6 months,

OR

--Two unscheduled clinic or emergency department visits for asthma within the past 12 months

-Sleeps in the target home greater than or equal to 5 nights per week

(Assessed at beginning of enrollment/baseline visit)

  • Target home has greater than or equal to 30 cockroaches trapped in a 3 day period
  • Positive ImmunoCAP Rapid test result to cockroach allergen

EXCLUSION CRITERIA:

A child will be excluded from this study if the following criteria apply, as determined in the screening phone call and/or confirmed at the baseline visit:

  • The child has other serious medical or chronic illnesses, other than asthma, such as:

    • Any hematologic, metabolic/endocrine, respiratory (other than asthma), cardiac or neurologic disorder requiring daily medications;
    • Any severe behavioral problem that prohibits the child or the child s caregiver from answering questions or following instructions;
    • Any autoimmune disease including rheumatoid arthritis, lupus, and myositis;
    • Any immune deficiency;
    • Any other serious medical condition such as juvenile diabetes mellitus, hypothyroidism, hyperthyroidism, cerebral palsy, hyperimmunoglobulin E syndrome, or diagnosed allergic bronchopulmonary aspergillosis.
  • Plans to move within the 12 months of study enrollment
  • Has no caregiver with access to a phone

Sibling or other household member currently participating in the study.

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
Change in the mean number of maximum asthma symptom days.

次要结果测量

结果测量
Asthma-related medical care resource utilization, Lung function, Medication use, Cockroach Number and Allergen Reductions.

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。

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

2011年9月4日

初级完成 (实际的)

2013年11月15日

研究完成 (实际的)

2013年11月15日

研究注册日期

首次提交

2011年9月10日

首先提交符合 QC 标准的

2011年11月9日

首次发布 (估计)

2011年11月10日

研究记录更新

最后更新发布 (实际的)

2019年12月9日

上次提交的符合 QC 标准的更新

2019年12月6日

最后验证

2013年11月15日

更多信息

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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