Environmental Control as Add-on Therapy in Childhood Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- The Medication Treatment Step Assigned
研究概览
简要总结
This study evaluates the effects of adding on an environmental home intervention to standard asthma medication management on controller medication requirements among children and adolescents with asthma. The investigators hypothesize that the addition of an individually-tailored, multi-faceted Environmental Control Strategy (ECS) to guidelines-based controller medication will result in less controller medication requirement and allergic inflammation than controller medication alone among urban asthmatic children.
详细描述
The study is a parallel arm study of an individually tailored, multi-faceted ECS plus controller medication titration versus controller medication titration alone. After a 4-week run-in period to stabilize the asthma, the investigators will randomize 200 Baltimore children with persistent asthma and a recent exacerbation in a 1:1 ratio to the two arms and follow the children for six months. There will be five clinic visits and three home visits over this time period for clinical and home assessments, respectively. There will be up to four environmental intervention visits for participants randomized to the environmental control plus controller medication group. The environmental modules include mouse, cockroach, furry pets, dust mites, and smoking. Air purifiers and laundered bedding are also included in this arm. Participants randomized to the controller medication group have the option of having one home visit after completing the study at which the participants will receive home intervention services that the environmental control plus controller medication group received. Participants will have repeated assessment of: controller medication requirements; secondary clinical, physiologic, and inflammatory outcomes; and particulate matter (PM), air nicotine, and allergen levels.
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
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 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 baseline visit, or asthma symptoms for at least 1 year
- •Meet criteria for current persistent asthma defined as either:
- •On a long-term controller medication for asthma, or
- •Meet National Asthma Education and Prevention Program (NAEPP) guideline requirements for persistent disease:(46)
- •Asthma symptoms 3 or more days per week over the past 2 weeks or
- •Nocturnal asthma symptoms at least 3 times in the past month
- •Have evidence of uncontrolled disease as defined by at least one of the following:
- •One asthma-related unscheduled visit to an emergency department (ED), clinic or urgent care facility in the previous 12 mo
- •One asthma-related overnight hospitalization in the previous 12 mo
- •One or more bursts of oral corticosteroids in the previous 12 mo
- •Reside within a geographic area of the study site so that home visits are feasible.
- •Have no plans to move within the upcoming 6 months
- •Have insurance to cover prescription medications.
- •Have a positive skin test (net wheal ≥2mm) to cat, dog, mouse, cockroach, or dust mites or have a positive cat, dog, mouse, German cockroach, or D. farinae-specific immunoglobulin E (IgE) test, as quantified using the ImmunoCAP system (≥0.35 kU/L)
排除标准
- •Lung disease, other than asthma, that requires daily medication
- •Cardiovascular disease that requires daily medication, excluding hypertension
- •Taking a beta-blocker
- •Allergy to dairy
- •On Xolair < 5 months
- •On immunotherapy and has not reached maintenance dose
- •Sleeping in another home 4 or more nights/week
- •Active smoker defined as a positive urine screen for high levels of urine cotinine
- •Unable to access areas of home necessary to conduct extermination
研究组 & 干预措施
ECS + Medication Group
The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
干预措施: Flovent Diskus (Drug)
ECS + Medication Group
The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
干预措施: Home Environmental Intervention (Other)
ECS + Medication Group
The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
干预措施: Advair Diskus (Drug)
Medication Group Alone
inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
干预措施: Flovent Diskus (Drug)
Medication Group Alone
inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
干预措施: Advair Diskus (Drug)
结局指标
主要结局
The Medication Treatment Step Assigned
时间窗: 6 month clinic visit
The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.
次要结局
- Daily Inhaled Corticosteroid Dose(6 months)
- Number of Asthma Symptom Days(6 months)
- Number of Asthma Exacerbations(6 months)
- Exhaled Nitric Oxide(6 months)
- FEV1/FVC(6 months)