1/2 Multi-Center CLEAN AIR 2 Randomized Control Trial in COPD

1/2 慢性阻塞性肺病多中心 CLEAN AIR 2 随机对照试验

• 批准号: 10722731
• 负责人: Nadia N Hansel
• 金额: $ 182.66万
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10722731
• 关键词: Acute; Address; Adherence; Adult; Air; Baltimore; Biomass; Carbon; Caring; Cause of Death; Chronic; Chronic Obstructive Pulmonary Disease; Clinical; Collaborations; Complex Mixtures; Controlled Clinical Trials; Cost Effectiveness Analysis; Data; Data Coordinating Center; Dose; Economics; Evidence based intervention; Exposure to; Gases; Geographic Locations; Guidelines; Health; Home; Individual; Indoor environment; Inhalation; Intention; International; Intervention; 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; Pulmonary Inflammation; Quality of life; Quality-Adjusted Life Years; Questionnaires; Randomized; Randomized, Controlled Trials; Recommendation; Respiratory Signs and Symptoms; Risk; Risk Reduction; Site; Societies; Source; Symptoms; Third-Party Payer; Time; Viral; Water; air cleaner; airway epithelium; airway inflammation; cigarette smoke; clinical efficacy; clinical practice; combustion product; cost effective; cost effectiveness; disabling disease; economic evaluation; effective intervention; effectiveness evaluation; effectiveness testing; former smoker; health care service utilization; high risk; improved; incremental cost; indoor air; indoor pollutant; markov model; mortality; novel strategies; particle; pollutant; portability; primary endpoint; primary outcome; recruit; respiratory; respiratory morbidity; response; secondary analysis; 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是全球死亡和发病率的主要原因，是归因于 有毒气体和颗粒的骨料负担，他们在其一生中吸气。在美国，这种曝光 主要是香烟烟；但是，即使在戒烟之后，COPD患者仍在继续遭受痛苦 呼吸发病率。国际2022 COPD指南（黄金）强调非药物 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 特别关心的是，患有COPD的成年人在家中花费了> 90％的时间。颗粒物（PM）和 二氧化氮（NO2）是室内环境中的常见污染物，导致呼吸道发病率较差。 我们自己的研究发现，患有更高接触室内污染物的COPD的前吸烟者会更糟 呼吸特异性的生活质量，症状和呼吸道加重的风险更高。我们的小组最近 在马里兰州巴尔的摩（PI Hansel）的COPD完成了116名前吸烟者的随机对照试验， 证明将两个具有高效率颗粒空气和碳的便携式空气清洁剂放置 过滤器可以显着降低家庭PM和NO2浓度。在意向性治疗分析中，有一个 圣乔治呼吸问卷衡量的趋势是更好的呼吸特异性生活质量 （SGRQ）和统计学上明显降低中度加重的风险，但不会严重加重 那些接受了主动空气清洁剂的人与假。此外，每个协议分析表明剂量 回复;在那些至少80％的时间使用空气清洁剂的人中，具有统计学意义 改善SGRQ。尽管结果令人鼓舞，但该研究仍未达到其主要终点，也没有 有动力确定空气清洁剂是否可以减少中等/严重的恶化，包括 急性医疗保健利用。此外，该试验不包括提高依从性的策略；和结果 仅限于一个小地理区域，从而限制了普遍性。拟议的研究是III期多中心 随机假手术控制的环境试验，以测试靶向空气清洁器的有效性 室内污染物（PM和NO2）关于以前吸烟者的生活质量和加剧风险降低 在多个临床实践位置进行了COPD（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效力以支持政策决策。我们假设这一点 放置两个具有高效率颗粒空气和碳过滤器的便携式空气清洁剂，可能会导致 改善生活质量，降低COPD加剧风险以及减少使用救援药物的需求。最后， 我们假设使用便携式空气清洁剂具有成本效益。审判将提供一种新颖的方法 改善这些发病率明显的患者的生活质量；以及为预防COPD加重， 这推动了这种慢性残疾疾病的发病率和死亡率。除了解决临床功效之外， 研究结果将提供经济评估，以支持有关报销的政策决策。