Benefits of High Efficiency Filtration to Children With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 2
- 主要终点
- Days with asthma symptoms
研究概览
简要总结
Two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study to look at the effectiveness of high efficiency filtration of indoor air in homes on reducing asthma symptoms. One intervention group will have high efficiency filters or filtration systems installed in their central heating and air conditioning (HVAC) system. The second intervention group will have high efficiency portable air cleaners placed in the child's bedroom and in the main living area. Each participant will receive true air filtration for a year and a placebo for a year. During the placebo period a sham filter will be used that removes very little of the particles. Measures of health effects will include days of symptoms, unplanned utilization of the healthcare system for asthma-related illness, short-term medication use, peak exhaled flow, spirometry, and exhaled nitric oxide (eNO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6-12 years of age
- •Living in Fresno, San Bernardino or Riverside Counties.
- •Physician diagnosed asthma, as stated by the participant's caregiver.
- •In the last six months, the child must have had asthma symptoms at least twice a week for several weeks in a row.
排除标准
- •Children living in homes where more than 2 cigarettes are smoked per week in the home.
- •Children that spend 2 or more nights per week in another home.
- •Children living in homes that are planning on moving in the next 2 years.
- •Children living in homes that keep their windows open most of the time.
- •Children living in homes that have existing high efficiency filtration.
结局指标
主要结局
Days with asthma symptoms
时间窗: Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months
The maximum number of days with symptoms, from a two-week recall period, will be determined every three months. The maximum number of days with symptoms will be defined as the largest value among the following three variables: (i) number of days with wheezing, tightness in the chest, or cough because of asthma, (ii) number of days that the child had to slow down or stop his/her play or activities because of asthma, wheezing or tightness in the chest, or cough, or (iii) number of nights that the child woke up because of asthma, wheezing or tightness in the chest, or cough. The seasonally adjusted mean difference in the number of symptom days between the true and sham filtration periods will be estimated using generalized linear mixed-effects regression models.
次要结局
- Forced expiratory volume at one second, percent predicted (FEV1 % predicted)(Measured at 12 months and 24 months)
- Allergy symptoms(Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months)
- Forced vital capacity, percent predicted (FVC % predicted)(Measured at 12 months and 24 months)
- Days of missing school due to asthma(Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months)
- Days of missing work for parents due to child's asthma(Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months)
- Peak Expiratory Flow Rate (PEFR)(Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months)
- Exhaled NO(Measure at 6, 12, 18, and 24 months)
- Unplanned Steroid treatments(Count during 1-year true filtration period and count during 1-year sham filtration period)
- Mini Pediatric Asthma Quality of Life Questionnaire (MiniPAQLQ)(Measured at 3, 6, 9, 12, 15, 18, 21, and 24 months)
- Respiratory disease(Count of incidents of respiratory disease during 1-year true filtration period and count during 1-year sham filtration period)
- Hospitalizations(Count during 1-year true filtration period and count during 1-year sham filtration period)
- Unplanned Clinic Visits(Count during 1-year true filtration period and count during 1-year sham filtration period)
- Emergency Room Visits(Count during 1-year true filtration period and count during 1-year sham filtration period)