Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- PM2.5 Concentration (ug/m^3)
研究概览
简要总结
This study is about asthma and how the environment affects asthma. Scientists know that air pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms worse. This research is being done to study how the health of a person with asthma responds to an air cleaner. The investigator hypothesize that an air cleaner will improve the health of persons with asthma.
详细描述
The investigators seek to determine the effect of placing air cleaner devices in the homes of adults with asthma on the adults' asthma health. To this end, the investigators aim to study 40 adults with asthma that are 18-50 years of age and live in Baltimore. Participants will receive either true air cleaners or sham cleaners in a blinded, randomized manner for one month, and then, after a washout period, participants will cross over and receive the other intervention (sham or true cleaner). All participants will have environmental monitoring (personal and in-home) to determine participants' particulate matter exposure, and be followed repeatedly during the 3 month study period for markers of asthma disease, including respiratory symptoms, medication and health care utilization, pulmonary function, systemic markers of inflammation, and bronchoscopic evidence of airway inflammation or epithelial cell dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-50 years of age
- •Non-smoker (<100 cigarettes in lifetime)
- •Physician diagnosis of asthma
- •Symptoms of asthma and/or reliever medication use in the past 6 months
- •Living in the current residence >= 6 months within Baltimore
- •Enrollment in, and completion of, the observational environmental asthma study "Inhale 1"
排除标准
- •Current diagnosis of another major pulmonary disease, other significant morbidity
- •Pregnancy (as defined by a positive urine pregnancy test at screening of all women of child-bearing potential)
- •Planning to relocate residence or activity that necessitates travel away from home for prolonged period of time during the study period
- •Current use of an air cleaner in the home
研究组 & 干预措施
Air cleaner then sham air cleaner
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
干预措施: High Efficiency Particulate Air Cleaner (Device)
Air cleaner then sham air cleaner
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
干预措施: Sham air cleaner (Device)
Sham air cleaner then air cleaner
A sham air cleaner will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
干预措施: High Efficiency Particulate Air Cleaner (Device)
Sham air cleaner then air cleaner
A sham air cleaner will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
干预措施: Sham air cleaner (Device)
结局指标
主要结局
PM2.5 Concentration (ug/m^3)
时间窗: Approximately 1 month
Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.
PM2.5-10 Concentration (ug/m^3)
时间窗: Approximately 1 month
Coarse particulate matter (PM2.5-10) concentration as assessed by a passive filter placed in the participant's home.
次要结局
- Number of Symptom-free Days(7 days)
- Number of Days With Activity Limitations(7 days)
- Number of Nights Disrupted by Asthma Symptoms(7 nights)
- Number of Days of School/Work Missed Due to Asthma Symptoms(7 days)
- Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms(7 days)
- Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI)(Approximately 1 month)
- Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ)(Approximately 1 month)
- Air Nicotine Concentration (ug/m^3)(Approximately 1 month)
- Bronchoalveolar Lavage Differential Neutrophil Count(1 Day)
- Bronchoalveolar Lavage Differential Eosinophil Count(1 day)
- Pre-bronchodilator Forced Vital Capacity (Litres)(1 day)
- Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)(1 day)
- FEV1 Percentage of FVC(1 day)