A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD

家庭空气净化治疗嗜酸性慢性阻塞性肺病的随机对照试验

• 批准号: 10579195
• 负责人: Mary B Rice
• 金额: $ 74.33万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-15 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10579195
• 关键词: Adult; Affect; Age Years; Air; Air Pollution; Allergens; Allergic; Anti-Inflammatory Agents; Asthma; Biological; Biological Assay; Blinded; Blocking Antibodies; Cause of Death; Child; Chronic Obstructive Pulmonary Disease; Clinical; Communities; Disease; Disease Progression; Dust; Elements; Engineering; Environmental Epidemiology; Eosinophilia; Epidemiologist; Excision; Exposure to; Extrinsic asthma; Functional disorder; Funding; Goals; Health; Health Status; Home; Home environment; Hypersensitivity; Indoor Air Quality; Inflammation Mediators; Inflammatory; Inhalation; Inhalation Exposure; Intervention; Knowledge; Liquid substance; Lung diseases; Measures; Medical; Metals; Methods; Nasal Epithelium; Nose; Particulate; Patients; Persons; Pharmaceutical Preparations; Pilot Projects; Positioning Attribute; Prevention; Prospective Studies; Questionnaires; Randomized, Controlled Trials; Reproducibility; Research; Research Personnel; Respiratory Signs and Symptoms; Respiratory System; Rice; Sampling; Schools; Scientist; Site; Steroids; Symptoms; Testing; Therapeutic; United States; United States National Institutes of Health; Upper respiratory tract; airway inflammation; asthmatic; atopy; biomarker identification; care seeking; cost; design; disorder control; eosinophil; former smoker; high efficiency particulate air filter; high risk; improved; indoor air; indoor pollutant; longitudinal analysis; multidisciplinary; non-smoking; novel; particle; pollutant; primary outcome; pulmonary function; respiratory; respiratory health; response; side effect; symptomatic improvement; tool; translational scientist

PROJECT SUMMARY/ABSTRACT Chronic obstructive pulmonary disease (COPD) is an incurable and deadly disease that affects 15% of adults over 40 years of age in the United States, and is exacerbated by exposure to air pollution. Up to 40% of COPD patients have a more inflammatory subtype with eosinophilia (>150 eosinophils per µL) and appear to be more responsive to anti-inflammatory medications, including inhaled steroids and novel targeted antibodies that block eosinophil formation. However, these medications are expensive and have adverse side effects. It is unknown if prevention of exposure to air pollution and allergens—which have been demonstrated to interact with each other to cause airway inflammation—may be of therapeutic benefit in eosinophilic COPD. High efficiency particulate air (HEPA) purifiers hold great promise to improve COPD symptoms and lung function, because they effectively remove particles from the indoor air, including traffic-related particles that are associated with reduced lung function in COPD, and allergens that can provoke airway inflammation, especially in those with atopy which is common in eosinophilic COPD. Recent studies have found that HEPA filters improve symptoms and lung function for allergic asthma, but this intervention has never been evaluated for eosinophilic COPD. The overall objective is to evaluate the effect of a one-year blinded randomized controlled trial of a HEPA vs sham air purifier intervention on lung function, respiratory symptoms, and the upper respiratory tract (as a site of inhaled exposure and biologic response) among 200 former smokers with eosinophilic COPD. The central hypothesis is that removal of particles in the bedroom and living room by a HEPA air purifier will improve the respiratory health of patients with eosinophilic COPD. The first aim will test if a one-year HEPA filter intervention in the bedroom and living room affects lung function (primary outcome), respiratory symptoms, and health status compared to sham filter. The second aim will test if the intervention affects levels of inflammatory mediators in the nasal epithelial lining fluid. The third (exploratory) aim will evaluate if the intervention affects levels of certain dust- and combustion-related metals in the nasal epithelial lining fluid. The investigators hypothesize that improved air quality due to HEPA filters will improve lung function, respiratory symptoms, and health status by St. George Respiratory Questionnaire. It is further hypothesized that air purification will reduce inflammatory mediators relevant to allergic and non-allergic airway pathophysiology, and also reduce dust- and combustion-related metals in the upper respiratory tract. The findings of this project may provide the medical community with two new tools—(1) a HEPA filter intervention, and (2) an assay of upper respiratory exposure and response—that can be used to promote healthier lives among people with eosinophilic COPD. Without such knowledge, the medical community may miss an opportunity to reduce exposure to noxious particles that drive disease progression, and instead rely only on costly medications for disease control in this more inflammatory subtype of COPD.

项目摘要/摘要 慢性阻塞性肺疾病（COPD）是一种无法治愈的致命疾病，影响了15％ 美国40岁以上的成年人因暴露于空气污染而加剧。多达40％ COPD患者的亚型具有更大的炎性亚型，嗜酸性粒细胞（> 150个嗜酸性粒细胞每µL）似乎 对抗炎药的反应更敏感，包括内部类固醇和新型靶向抗体 那阻断嗜酸性粒细胞的形成。但是，这些药物很昂贵，并且具有不利的副作用。它 尚不清楚预防暴露于空气污染和过敏原（已被证明是相互作用的） 彼此彼此引起气道炎症 - 可能在嗜酸性COPD中具有治疗益处。高的 效率颗粒空气（HEPA）净化器具有改善COPD症状和肺功能的巨大希望， 因为它们有效地从室内空气中去除颗粒，包括与交通相关的颗粒 与COPD中的肺功能降低以及可以引起气道注射的过敏原相关， 尤其是在嗜酸性粒细胞COPD中常见的特应性的。最近的研究发现HEPA 过滤器改善了过敏性哮喘的症状和肺功能，但是这种干预从未评估过 用于嗜酸性COPD。总体目的是评估一年盲随机的效果 HEPA与假空气净化器干预的对照试验对肺功能，呼吸道症状和 在200名前吸烟者中 嗜酸性COPD。中心假设是通过 HEPA空气净化器将改善嗜酸性COPD患者的呼吸健康。 第一个目标将测试一年的HEPA过滤器干预卧室和客厅是否影响肺 与假滤波器相比，功能（主要结果），呼吸道症状和健康状况。第二个目标 将测试干预措施是否影响鼻皮衬里炎症介质的水平。第三 （探索性）AIM将评估干预措施是否影响某些与粉尘和混合物相关金属的水平 鼻上皮衬里。调查人员假设由于HEPA过滤器而提高的空气质量将 改善圣乔治呼吸问卷的肺功能，呼吸症状和健康状况。这是 进一步假设，空气纯化将减少与过敏和非过敏性相关的炎症介质 气道病理生理学，还减少上呼吸道中与粉尘和混合物相关的金属。 该项目的发现可能会为医学界提供两个新工具 - （1）HEPA过滤器 干预，以及（2）对上呼吸道暴露和反应的评估 - 可用于促进 在患有嗜酸性粒细胞COPD的人中生活更健康。没有这样的知识，医学界可能 错过了减少驱动疾病进展的有害颗粒的机会，而是依靠 仅在COPD的这种炎症性亚型中进行疾病控制的昂贵药物。