Location and timing of inhaler use, exacerbations and physical activity in COPD

描述（由申请人提供）： 慢性阻塞性肺疾病（COPD）影响高达20%的VA患者，并与健康相关的生活质量差、频繁加重和残疾相关。建议COPD患者进行体力活动（PA），但PA可能会受到空气污染和温度变化等环境因素引发的急性加重和呼吸道症状恶化的影响。短效β受体激动剂支气管扩张剂使用的增加可能反映了急性环境暴露、轻度急性加重或中度或重度急性加重开始时的一过性症状恶化。最近开发的全球定位系统（GPS）启用吸入器允许监测支气管扩张剂使用的位置和时间。使用GPS吸入器测量β-激动剂使用的增加是测量轻度急性加重的一种新方法，将有助于更好地了解加重COPD和干扰PA的环境因素。研究的具体目标是：目标1：使用启用全球定位系统（GPS）的短效β-受体激动剂（SABA）吸入器装置记录呼吸道症状恶化和轻度加重。目的2：使用计步器和体力活动检查表表征COPD患者的PA。目标3：检查环境触发因素（空气污染、温度、相对湿度）是否与通过启用GPS的SABA吸入器装置测量的轻度加重相关。拟定研究将是一项在40名患有中度至重度COPD的退伍军人中进行的纵向观察性研究。如果从VA Puget Sound医疗保健系统诊断为COPD的参与者的肺量计结果显示FEV 1/FVC在0.3和0.7之间，并且正在使用短效支气管扩张剂（例如，沙丁胺醇）通过定量吸入器（MDI）递送。将启用GPS的监测设备放置在患者的MDI罐的顶部，以记录MDI使用的时间和位置。参与者将被跟踪总共12周。从研究中确定的数据将包括吸入器使用的每日测量值（时间、位置）、每日运动（每30分钟进行一次GPS监测）和每日步数计测量值。患者将每月进行一次研究访视，以下载GPS和计步器数据，并填写有关急性加重史、PA最后7天和慢性呼吸道症状的问卷。此外，将要求患者填写7天活动日记，以收集有关其日常活动的更详细信息。全天患者位置和MDI启动地点的GPS数据将与环境保护局（EPA）的西雅图空气污染数据和国家海洋和大气管理局（NOAA）的气象数据相关联。数据分析将侧重于每项测量的描述性统计，表征短效β受体激动剂使用的增加，并测量患者对GPS功能MDI、计步器和活动日记的依从性。 本研究的结果将用于告知Merit审查提案，以评价COPD患者急性加重对PA干预的影响以及环境触发因素对这些急性加重的贡献。具体而言，未来研究的目标是：（1）确定因素（包括使用启用GPS的MDI测量的轻度急性加重）与参与体力活动、锻炼计划和肺康复的减少相关，以及2）开发增加COPD体力活动的干预措施，包括预防急性加重的策略，包括避免环境触发因素，并在经历恶化后保持体力活动。 通过更好地了解轻度急性发作对PA的影响，以及轻度急性发作的潜在环境触发因素，我们可以为患者及其提供者提供有关如何减少急性发作并在家中发展和维持PA的更适当建议。

DESCRIPTION (provided by applicant): Chronic Obstructive Pulmonary Disease (COPD) affects up to 20% of VA patients and is associated with poor health-related quality of life, frequent exacerbations, and disability. Physical activity (PA) is recommended for COPD patients, however PA may be affected by exacerbations and worsening respiratory symptoms triggered by environmental factors such as air pollution and changes in temperature. Increased use of short acting beta- agonist bronchodilator use may reflect transient worsening symptoms in the setting of an acute environmental exposure, a mild exacerbation, or the beginning of a moderate or severe exacerbation. A recently developed global positioning system (GPS)-enabled inhaler permits monitoring of both location and timing of bronchodilator use. Measuring increased beta-agonist use with the GPS-enabled inhaler is a novel method to measure mild exacerbations and will allow a better understanding of environmental factors that worsen COPD and interfere with PA. The study specific aims are: Aim 1: To capture worsening respiratory symptoms and mild exacerbations with a global positioning system (GPS)-enabled short-acting beta-agonist (SABA) inhaler device. Aim 2: To characterize PA in patients with COPD using pedometers and a Physical Activity Checklist. Aim 3: To examine whether environmental triggers (air pollution, temperature, relative humidity) are linked to mild exacerbations as measured by GPS-enabled SABA inhaler device. The proposed study will be a longitudinal observational study of 40 Veterans with moderate to severe COPD. Participants diagnosed with COPD from the VA Puget Sound Health Care System will be asked to participate if they have an FEV1/FVC between 0.3 and 0.7 on spirometry and are using a short-acting bronchodilator (e.g., albuterol) delivered by metered-dose inhaler (MDI). The GPS-enabled monitoring device will be placed on top of the patient's MDI canister to record the time and location of MDI use. Participants will be followed for a total of 12 weeks. Data ascertained from the study will include daily measurements of inhaler use (time, location), daily movements (GPS monitoring every 30 minutes), and daily pedometer measurements of steps taken. Patients will have monthly study visits to download GPS and pedometer data and to fill out questionnaires about history of exacerbations, the last 7 days of PA, and chronic respiratory symptoms. Additionally, patients will be asked to fill out a 7-day activity diary to collect more detailed information about their daily routines. GPS data on patient location throughout the day and place where the MDI was actuated will be linked to data on Seattle air pollution from the Environmental Protection Agency (EPA) and meteorology data from the National Oceanic and Atmospheric Administration (NOAA). Data analysis will focus on descriptive statistics for each measure, characterizing increased short-acting beta agonist use, and measuring patient compliance with the GPS-enabled MDI, pedometer, and activity diary. The results of this study will be used to inform a Merit Review proposal to evaluate the impact of exacerbations on a PA intervention for COPD patients and the contribution of environmental triggers to these exacerbations. Specifically the goals of the future study would be to: 1) determine the factors (including mild exacerbations measured using GPS-enabled MDI use) associated with decreased participation in physical activity, exercise programs, and pulmonary rehabilitation, and 2) to develop an intervention to increase physical activity in COPD that incorporates strategies to prevent exacerbations including avoiding environmental triggers, and maintaining physical activity after experiencing exacerbations. By better understanding the effect of mild exacerbations on PA, as well as the potential environmental triggers of mild exacerbations, we can provide patients and their providers with more appropriate advice about how to reduce exacerbations and develop and sustain PA at home.