A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Change in forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
This study evaluates the influence of home air purification on the lung health of adults with eosinophilic COPD. Half of the participants will receive real air purifiers (HEPA filters) and half will receive sham air purifiers.
详细描述
Chronic obstructive pulmonary disease (COPD) is the third most common cause of death in the United States, and is exacerbated by exposure to air pollution. Knowledge about whether air purification affects the health of those with eosinophilic COPD (approximately 40% of all COPD patients seeking care), who generally have more active airway inflammation. If found to be beneficial, home air purification may offer a non-pharmacologic intervention for a large proportion of people with this common and serious disease.
This study will evaluate whether home air purification affects lung function, respiratory symptoms, nasal biomarkers (inflammatory proteins and metals) among people with eosinophilic COPD. Participants will be randomized to receive real or sham air purifier in the bedroom and living room for 12 months. The intervention group will receive two high efficiency particulate air (HEPA) air purifiers, while the control group will receive two sham air purifiers that look and sound the same as real HEPA air purifiers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sham air purifiers will be indistinguishable from real air purifiers. Only the research assistant installing the purifiers and the data coordinating center will have knowledge of assignment to real or sham purifiers.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 40 years or more
- •Physician diagnosis of COPD [Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) ≤70% and FEV1 (% predicted) <80%]
- •Blood eosinophil count of >=150 cells per μL at screening or in the previous year
- •Former smoker with tobacco exposure of >=10 pack-years
排除标准
- •Inability to complete monthly questionnaires
- •Inability to perform lung function testing
- •Regularly using a portable HEPA air purifier in the home at time of enrollment
- •End stage chronic disease with life expectancy <2 years as determined by PI judgment
- •Living in location other than home (e.g. long term care facility)
- •Planning to change residence within the study period
研究组 & 干预措施
Sham air purifier
Participants will receive a sham air purifier that will be installed in the bedroom and living room. These purifiers will make a noise, but will not filter the air.
干预措施: Sham air purifier (Device)
True air purifier
Participants will receive a HEPA air purifier in the bedroom and living room.
干预措施: Air purifier (Device)
结局指标
主要结局
Change in forced expiratory volume in 1 second (FEV1)
时间窗: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]
FEV1 is the volume of air exhaled in the first second of a forced exhalation maneuver. Lower volumes indicate worse lung function.
次要结局
- Change in functional capacity by 6 minute walk test(The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes)
- Change in respiratory symptoms(Monthly for 3 months preintervention and 12 months post-intervention)
- Change in health status (also called health-related quality of life) by St. George Respiratory Questionnaire(Baseline [3 months before intervention and day of intervention] and post-intervention [6 months and 12 months])
研究者
Mary Rice
Associate Professor of Medicine
Beth Israel Deaconess Medical Center