2/2 Multi-Center CLEAN AIR 2 Randomized Control Trial in COPD

2/2 慢性阻塞性肺病多中心 CLEAN AIR 2 随机对照试验

• 批准号: 10722232
• 负责人: Stephan Ehrhardt
• 金额: $ 65.85万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-10 至 2029-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10722232
• 关键词: Acute; Address; Adherence; Adult; Air; Baltimore; Carbon; Caring; Cause of Death; Chronic; Chronic Obstructive Pulmonary Disease; Clinical; Clinical effectiveness; Complex Mixtures; Controlled Clinical Trials; Cost Effectiveness Analysis; Data; Disease Outcome; Dose; Economic Burden; Economics; Emergency department visit; Evidence based intervention; Exposure to; Future; Gases; Geographic Locations; Guidelines; Health; Health Policy; Home; Hospitalization; Individual; Indoor Air Pollution; Indoor environment; Inhalation; Intention; International; Intervention; Lead; Link; Literature; Location; Measurable; Measures; Methods; Morbidity - disease rate; Nitrogen Dioxide; Outcome; Oxidative Stress; Participant; Particulate; Particulate Matter; Patients; Pharmaceutical Preparations; Phase; Policies; Prevention; Protocols documentation; Public Health; Pulmonary Inflammation; Quality of life; Quality-Adjusted Life Years; Questionnaires; Randomized; Randomized, Controlled Trials; Recommendation; Respiratory Signs and Symptoms; Risk; Risk Reduction; Shapes; Smoker; Societies; Source; Symptoms; Third-Party Payer; Time; Viral; Water; air cleaner; airway epithelium; airway inflammation; burden of illness; cigarette smoke; clinical efficacy; clinical practice; combustion product; cost effective; cost effectiveness; disabling disease; economic evaluation; economic impact; effectiveness evaluation; effectiveness testing; environmental intervention; former smoker; health care service utilization; high risk; improved; incremental cost; indoor air; indoor particulate matter; indoor pollutant; markov model; mortality; novel strategies; particle; pollutant; portability; primary endpoint; recruit; respiratory; respiratory morbidity; response; secondary outcome; smoking cessation; systemic inflammatory response; trend; trial design

PROJECT SUMMARY. COPD is a leading cause of death and morbidity worldwide and is attributable to the aggregate burden of toxic gases and particles that individuals inhale during their lifetime. In the US, this exposure is primarily cigarette smoke; however, even after smoking cessation, patients with COPD continue to suffer respiratory morbidity. International 2022 COPD guidelines (GOLD) emphasize non-pharmacological interventions to improve health, but few evidence-based interventions exist. The indoor environment is of particular concern, as adults with COPD spend >90% of their time in the home. Particulate matter (PM) and nitrogen dioxide (NO2) are common pollutants in indoor environments and lead to worse respiratory morbidity. Our own study found that former smokers with COPD who have higher exposure to indoor pollutants have worse respiratory-specific quality of life, symptoms, and a higher risk of respiratory exacerbations. Our group recently completed a randomized controlled trial of 116 former smokers with COPD in Baltimore, MD (PI Hansel), demonstrating that the placement of two portable air cleaners with high efficiency particulate air and carbon filters can significantly reduce in-home PM and NO2 concentrations. In intention-to-treat analysis, there was a trend toward better respiratory-specific quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ) and statistically significant lower risk for moderate exacerbation, but not severe exacerbations, among those who received the active air cleaner compared to sham. Further, per-protocol analysis suggested a dose- response; among those who used the air cleaner at least 80% of the time, with a statistically significant improvement in SGRQ. Despite encouraging results, the study did not meet its primary endpoint and was not powered to determine whether air cleaner interventions can reduce moderate/severe exacerbations, including acute health care utilization. Furthermore, the trial did not include strategies to increase adherence; and results are limited to a small geographic area, limiting generalizability. The proposed study is a Phase III multi-center randomized sham-controlled environmental trial to test the effectiveness of an air cleaner intervention targeting indoor pollutants (PM and NO2) on quality of life and exacerbation risk reduction among former smokers with COPD (n~770) across multiple clinical practice locations. We will conduct cost-effectiveness analysis to ensure that study results address both clinical and economic efficacy to support policy decisions. We hypothesize that the placement of two portable air cleaners with high efficiency particulate air and carbon filters can lead to improved quality of life, reduced COPD exacerbation risk and reduced need for rescue medication use. Lastly, we hypothesize that the use of portable air cleaners is cost-effective. The trial will provide a novel approach to improve quality of life in these patients with significant morbidity; and for the prevention of COPD exacerbations, which drive the morbidity and mortality of this chronic disabling disease. In addition to addressing clinical efficacy, the study results will provide an economic evaluation to support policy decisions regarding reimbursement.

项目摘要。COPD是世界范围内死亡和发病的主要原因， 个人在其一生中吸入的有毒气体和颗粒物的总负担。在美国， 主要是香烟烟雾;然而，即使在戒烟后，COPD患者仍继续遭受 呼吸道疾病国际2022年COPD指南（GOLD）强调非药物治疗 改善健康的干预措施，但几乎没有基于证据的干预措施。室内环境是 特别值得关注的是，因为患有COPD的成年人90%以上的时间都在家里。颗粒物（PM）和 二氧化氮（NO2）是室内环境中常见的污染物，并导致更严重的呼吸道疾病。 我们自己的研究发现，患有COPD的前吸烟者暴露于室内污染物的程度更高， 呼吸系统特异性生活质量、症状和呼吸道恶化风险较高。我们组最近 完成了一项在马里兰州巴尔的摩的116名COPD前吸烟者中进行的随机对照试验（PI Hansel）， 这表明，放置两个便携式空气净化器， 过滤器可以显著降低室内PM和NO2浓度。在意向治疗分析中， 通过圣乔治呼吸问卷测量，有改善泌尿外科特定生活质量的趋势 （SGRQ），中度急性加重风险统计学显著降低，但重度急性加重风险无统计学显著降低， 那些接受了主动空气净化器的人与假的人进行了比较。此外，按方案分析表明剂量- 反应;在那些使用空气净化器的人中，至少80%的时间，具有统计学显著性 改善SGRQ。尽管结果令人鼓舞，但该研究并未达到其主要终点， 有能力确定空气清洁器干预是否可以减少中度/重度加重，包括 急性卫生保健利用。此外，该试验不包括增加依从性的策略;结果 仅限于一个小的地理区域，限制了普遍性。拟定的研究是一项III期多中心研究， 随机假对照环境试验，以测试空气净化器干预的有效性， 室内污染物（PM和NO2）对前吸烟者生活质量和加重风险的影响 多个临床实践地点的COPD（n~770）。我们会进行成本效益分析， 该研究结果解决了临床和经济有效性，以支持政策决策。我们假设 放置两个具有高效微粒空气和碳过滤器的便携式空气净化器可导致 改善生活质量，降低COPD加重风险，减少急救药物使用需求。最后， 我们假设便携式空气净化器的使用是成本有效的。该试验将提供一种新的方法， 改善这些具有显著发病率的患者的生活质量;以及预防COPD恶化， 导致这种慢性致残疾病的发病率和死亡率。除了解决临床疗效外， 研究结果将提供经济评估，以支持有关偿还的政策决定。