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，可归因于 个人一生中吸入的有毒气体和颗粒物的总负担。在美国，这一曝光 主要是香烟烟雾；然而，即使戒烟后，慢性阻塞性肺病患者仍继续遭受痛苦 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，但很少有基于证据的干预措施。室内环境是 特别值得关注的是，患有慢性阻塞性肺病的成年人 90% 以上的时间都呆在家里。颗粒物 (PM) 和 二氧化氮（NO2）是室内环境中常见的污染物，会导致更严重的呼吸道疾病。 我们自己的研究发现，患有慢性阻塞性肺病的前吸烟者如果接触室内污染物较多，病情会更严重 呼吸系统特定的生活质量、症状和呼吸系统恶化的风险较高。我们组最近 在马里兰州巴尔的摩完成了一项针对 116 名患有慢性阻塞性肺病 (COPD) 的前吸烟者的随机对照试验 (PI Hansel)， 证明放置两个具有高效颗粒空气和碳的便携式空气净化器 过滤器可以显着降低室内 PM 和 NO2 浓度。在意向治疗分析中，有一个 根据圣乔治呼吸问卷调查，呼吸系统特定生活质量改善的趋势 （SGRQ），并且在统计上显着降低中度恶化的风险，但不是严重恶化的风险 那些接受主动空气净化器的人与假手术者相比。此外，根据方案分析表明剂量- 回复;在至少 80% 时间使用空气净化器的人中，具有统计显着性 SGRQ 的改进。尽管取得了令人鼓舞的结果，但该研究并未达到其主要终点，并且没有达到预期目的。 有助于确定空气净化器干预措施是否可以减少中度/重度恶化，包括 急性医疗保健利用。此外，该试验并未包括提高依从性的策略；和结果 仅限于较小的地理区域，限制了普遍性。拟议的研究是一项 III 期多中心研究 随机假对照环境试验，测试空气净化器干预措施的有效性 室内污染物（PM 和 NO2）对戒烟者的生活质量和恶化风险降低的影响 多个临床实践地点的慢性阻塞性肺病 (n~770)。我们将进行成本效益分析，以确保 该研究结果涉及临床和经济功效，以支持政策决策。我们假设 放置两个带有高效颗粒空气和碳过滤器的便携式空气净化器可能会导致 改善生活质量，降低慢性阻塞性肺病恶化风险并减少救援药物的使用需求。最后， 我们假设使用便携式空气净化器具有成本效益。该试验将提供一种新颖的方法 改善这些发病率较高的患者的生活质量；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。除了解决临床疗效之外， 研究结果将提供经济评估，以支持有关报销的政策决定。