Radon Asthma Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Asthma symptoms
研究概览
简要总结
To determine if radon mitigation can improve asthma
详细描述
We will conduct a randomized, double-blind, sham controlled trial to investigate the efficacy of radon mitigation in the homes of susceptible individuals to provide evidence for health benefits by improving indoor air quality. The trial will include 180 children with asthma. We will install a standard radon specific mitigation system in the participant's home. Health outcomes will be followed over 48 weeks to determine the outcomes of the intervention versus inactive (sham) control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have physician-diagnosed asthma at least 1 year prior to the screening visit
- •Have evidence of uncontrolled disease as defined by at least one of the following:
- •Use of an asthma medication during the prior 12 months, report of asthma symptoms over the prior 12 months (wheezing/whistling in the chest)(3)
- •One or more asthma-related hospitalization, emergency room visit
- •Unscheduled clinic or urgent care facility visit resulting in a burst of systemic steroids (3 days or more of prednisone or equivalent; 1 or more doses of dexamethasone) in the previous 12 months
排除标准
- •Not residing at the household for at least 5 days a week or family planning to move from the current home within the next twelve months, or homes with active radon mitigation systems (if home uses a HEPA filter air purifier, family must agree to disable the purifier for 28 days prior to randomization).
- •Lung disease, other than asthma, that requires daily medication (inflammatory diseases, chronic lung diseases aside from asthma, congenital cardiopulmonary conditions requiring medication or surgical treatment),
- •Homes with active HEPA filters will be excluded (even though the role of HEPA filters on radon and radon particles s is expected to be minimum and other exposures can be adjust for in the analysis)
- •Cardiovascular disease that requires daily medication, excluding hypertension
- •Taking a beta-blocker
- •Currently receiving unstable level of Immunotherapy (allergy shots)
- •Coordinator/PI judgment
- •Inability to perform lung function testing
- •Intake of abuse drugs or alcohol, have psychiatric disorders or severe mental disability that interferes with answering questions or following instructions.
研究组 & 干预措施
Active Radon Mitigation
Active radon mitigation system
干预措施: radon mitigation system (Other)
Inactive radon mitigation system control( sham)
Inactive radon mitigation system looks and sounds like active but doesn't reduce radon ( sham)
干预措施: Sham (No Treatment) (Other)
结局指标
主要结局
Asthma symptoms
时间窗: past 2 weeks
Number of Days With Asthma Symptoms
次要结局
未报告次要终点
研究者
Wanda Phipatanakul
S Jean Emans, MD Professor of Pediatrics
Boston Children's Hospital