Multi-Center Clean Air Randomized Controlled Trial in COPD
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 770
- 试验地点
- 18
- 主要终点
- St. George's Respiratory Questionnaire (SGRQ)
研究概览
简要总结
This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.
详细描述
The Multi-Center Clean Air Randomized Controlled Trial in COPD (Clean Air) is a multi-center, prospective, randomized, double-blind, sham-controlled trial that will enroll 770 former smokers with COPD over a 4-year period and follow participants at regular intervals for one year. The primary endpoint is respiratory specific quality of life. Secondary endpoints include rate of acute exacerbations, rescue medication use, quality of life, and cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, 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
- •To be eligible, subjects must meet all these criteria:
- •Age ≥ 40 years.
- •Self-report of physician diagnosis of COPD.
- •Spirometry confirmed airway obstruction (post-bronchodilator spirometry of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 0.7) as defined by the Global Initiative for Obstructive Lung Disease (GOLD) criteria (6, 11)
- •Tobacco exposure ≥ 10 pack-years. This refers to regular cigarette tobacco consumption.
- •Self-reported former smoker of at least 6 months' duration. This does not include e-cigarette use.
- •COPD Assessment Test (CAT) score ≥ 10, Modified Medical Research Council dyspnea scale (mMRC) ≥ 2, or history of moderate or severe exacerbation in the past 12 months (as defined by history of receiving a course of systemic corticosteroids or antibiotics for respiratory problems; or visiting an emergency department or being hospitalized for a COPD exacerbation within the past 12 months.)
排除标准
- •To be eligible, subjects must not meet any one of these criteria:
- •Living in a location other than home (e.g., long-term care facility, nursing home)
- •Other chronic lung diseases, except asthma
- •Condition with less than a year of life expectancy (e.g., metastatic cancer) or in hospice
- •Spends >2 months per year in location other than home; or plans to change residence in the next 12 months
- •Pregnant or breastfeeding
- •Current air cleaner use in the home (*If the individual is willing to discontinue use of the personal air cleaner, this person can be eligible if all other eligibility has been met)
- •Inability to bring air cleaners (about 15 pounds each) into home, either by self, friend, or relative
- •Deemed by the study investigator to be unable to complete study protocol, including likely lack of internet connectivity
- •Participating in another interventional clinical trial
研究组 & 干预措施
Sham air cleaner
The sham control treatment arm will receive two sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow, and overall appearance compared to active air cleaners, thus blinding participants to filter status.
干预措施: Sham air cleaner (Device)
Active air cleaner
The active arm will receive two active air cleaners with high efficiency particulate air (HEPA) filters which remove particulate matter (PM), as well as activated carbon filters to remove Nitrogen Dioxide (NO2) and other trace gases.
干预措施: Air cleaner (Device)
结局指标
主要结局
St. George's Respiratory Questionnaire (SGRQ)
时间窗: baseline and 3, 6, 9, and 12 months after baseline
The St. George's Respiratory Questionnaire (SGRQ) is a widely used measure of disease impact as an indicator of disease-specific quality of life. The SGRQ is a disease specific instrument containing 50 items in three subscales (symptoms, activity, and impact). Scores range from 0 to 100, with higher scores indicating more limitations.
次要结局
未报告次要终点
研究者
Stephan Ehrhardt
Associate professor
JHSPH Center for Clinical Trials