AIRWEIGHS: Investigating Obesity as a Susceptibility Factor for Air Pollution in Childhood Asthma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Maximum Symptom Days
研究概览
简要总结
Background: Asthma and obesity are public health crises that have concurrently risen over the past decades, affecting millions of children in the United States and disproportionately affecting low-income minority children in urban areas. The same children at highest risk for asthma and obesity also have greater exposure to indoor and outdoor pollution. Emerging evidence suggests that obesity may confer increased susceptibility to health effects of air pollution.
Methods: Aiming to provide causal-level evidence of these observational findings, we propose a home intervention study to 1) test whether targeted reductions of indoor Particulate Matter (PM) concentrations improve the respiratory health of overweight inner-city children with asthma more than that of lean inner-city children with asthma and 2) investigate mediators of susceptibility to indoor PM among overweight versus lean children with asthma. We will accomplish these aims using a 1:1 randomized controlled trial of 200 children with persistent asthma (half normal weight, half overweight) living in Baltimore City. Participants will be randomized to receive either two active air purifiers containing high-efficiency particulate air (HEPA) filters or two sham air purifiers with their filters removed.
Implications: If the aforementioned observational findings are confirmed, implications will be directly relevant to the over 170 million children around the world now estimated to be overweight or obese.
详细描述
The primary object of this study is to determine the efficacy of a targeted environmental intervention among overweight inner city children as compared to normal weight inner city children with asthma.
Specific Aim #1: To determine if overweight inner-city children, compared to lean inner-city children, have greater improvement in asthma with an air purifier intervention aimed at reducing indoor PM.
Hypothesis 1: An intervention using HEPA filter air purifiers in the homes of inner-city children with asthma will be associated with greater respiratory improvement in overweight children than in normal weight children.
Specific Aim #2a: To investigate mediators of susceptibility among overweight versus normal weight children with asthma.
Hypothesis #2. Candidate mediators, including increases in a) tidal volume and thereby increases in doses of inhaled particles, b) inflammatory and oxidative stress responses, c) corticosteroid resistance, and d) sleep disordered breathing mediate increased susceptibility to indoor PM among overweight versus normal weight children with asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8-17 years of age
- •Persistent asthma (NAEPP criteria)
- •Exacerbation in previous 12 months
- •Spends ≥4 nights/week at home
- •No plans to move during the study
排除标准
- •Significant pulmonary or cardiac disease
- •Home not appropriate candidate due to disrepair
- •Underweight, defined by BMI <5th percentile
结局指标
主要结局
Maximum Symptom Days
时间窗: Baseline and about 12 weeks after the intervention
We have chosen symptoms based on the strong relationship between symptoms and PM observed in previous studies. Symptoms during the previous two weeks will be captured with standardized questions used in many inner-city asthma studies, including our own that detected a strong association between indoor PM and asthma symptoms. A 'maximum symptom days' variable will constructed as the maximum of the variables: days of slowed activity, days of wheezing, coughing or chest tightness when running or going upstairs, and nights of waking with asthma symptoms in the past two weeks. We will administer questionnaires to the primary caregiver of children 8-11 years and to both participant and caregiver for adolescents age 12-17. Previous studies have indicated concordance between adolescent and the caregiver responses, and we will collect data to assess concordance within our study population. Individual symptom variables will serve as secondary outcomes.
次要结局
- Asthma Symptoms(Baseline and about 12 weeks after the intervention)
- Lung Function(Baseline and about 12 weeks after the intervention.)
- Asthma Control(Baseline and about 12 weeks after the intervention)
- FENO(Baseline and about 12 weeks after the intervention)
- Health Care Utilization(Baseline and about 12 weeks after the intervention)