Assessing the Effect of Different Efficiency Indoor Air Filters on Respiratory Symptoms in Former Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in SGRQ-C score
研究概览
简要总结
The investigators will conduct a randomized, controlled, double-blind, crossover trial to determine whether the presence of a portable high-efficiency indoor air filter in the bedroom reduces respiratory symptoms in former smokers compared with placebo. The primary outcomes will be change in St. George's Respiratory Questionnaire - COPD (SGRQ-C) score associated with using a portable high-efficiency indoor air filter during the study period. Secondary outcomes of COPD exacerbations and hospitalizations, daily step counts, medication changes, spirometry, and cardiovascular outcomes will also be assessed.
详细描述
Hypothesis/Research Questions:
This study will determine whether the presence of a portable high-efficiency indoor air filter in the bedroom improves respiratory symptoms (based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score) during a period of high air pollution compared with placebo in former smokers with respiratory symptoms.
The primary outcome will be the change in SGRQ-C score associated with using a portable high-efficiency indoor air filter during the study period.
Secondary outcomes will assess the effect of using a portable high-efficiency indoor air filter on healthcare utilization, other symptom scores, COPD exacerbation frequency, medication use, median daily step counts, inflammatory markers, oxygenation, indoor particulate counts and indoor-outdoor particulate count difference, and pulmonary function tests.
Baseline descriptive statistics will report baseline air filter type, duration of use, and particulate weight prior to study enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •history of smoking
- •Do not currently smoke and no one currently smokes inside the home
- •history of exacerbation or development of respiratory symptoms (e.g.cough, sputum production, chest tightness, exertional dyspnea, etc.) with periods of high outdoor air pollution ("inversions")
- •Age 40 or older
- •Access to Wi-Fi
- •Access to a cell phone, tablet or personal computer
排除标准
- •active tobacco use of subject
- •active tobacco use in the home
- •pre-existing use of a HEPA filter in the subject's bedroom
研究组 & 干预措施
ARM 1 MERV17 first
This group will receive a portable HEPA air filtering device with MERV17 air filter for the first part of the study. At cross over, this group will receive the "placebo" or no high-efficiency filter.
干预措施: HEPA portable air filter (Other)
ARM 2 MERV17 second
This group will receive a HEPA portable air filter with no high efficiency air filter for the first part of the study. At cross over, this group will receive the high-efficiency MERV17 air filter.
干预措施: Sham Control/Active Comparator (Other)
结局指标
主要结局
Change in SGRQ-C score
时间窗: 12 weeks
based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score
次要结局
- Effect of air filtration on healthcare utilization(6 months)
- Aggregated assessment of the effect of air filtration on COPD exacerbation frequency(6 months)
- Change in 6 minute walk test(3 months)
- Number of cardiovascular events(6 months)
- Change in median daily step counts(6 months)
- Change in inflammatory markers(6 months)
- Change in spirometry(3 months)