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临床试验/NCT02661321
NCT02661321已完成不适用

Location and Timing of Inhaler Use, Exacerbations and Physical Activity in Chronic Obstructive Pulmonary Disease

VA Puget Sound Health Care System0 个研究点目标入组 35 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
主要终点
Exacerbations

研究概览

简要总结

This was an observational pilot study to examine the usefulness of an electronic sensor that monitors short-acting beta-agonist inhaled medication use. The goals of this study were to: 1) test the feasibility of using the inhaler sensor to measure worsening symptoms and exacerbations, 2) characterize physical activity in patients with COPD, and 3) examine whether environmental factors can be linked to mild exacerbations measured by the inhaler sensor.

详细描述

Objectives: This study tested the usefulness of a GPS-enabled inhaler to study the associations between air pollution, chronic obstructive pulmonary disease (COPD) exacerbations, and physical activity. Specific aims are 1) test the feasibility of using the inhaler sensor to measure worsening symptoms and exacerbations, 2) characterize physical activity in patients with COPD, and 3) examine whether environmental factors can be linked to mild exacerbations measured by the inhaler sensor.

Research Design: A 12-week observational, longitudinal pilot study of patients with COPD.

Methodology: Participants recruited at VA Puget Sound performed spirometry and completed baseline questionnaires. An inhaler sensor was placed on their albuterol inhaler to record the time and location of inhaler actuation throughout the three month follow-up. Each month participants answered questions regarding their breathing symptoms and physical activity. Physical activity was measured by self-report using a weeklong Physical Activity Checklist. A pedometer was worn at three 7 day periods. Public use air pollution and meteorological data will be linked to the inhaler data. We will compute descriptive statistics for all measures, including sociodemographics, exacerbation rates, inhaler use, air pollution exposures and physical activity levels. In addition, a time series analysis will be used to test if the frequency of inhaler use is associated with higher levels of daily air pollution.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • FEV1/FVC<0.70
  • FEV1 >30% and <FEV1<65% predicted
  • Participants must be able to walk without assistance
  • No plans to leave the study area during the 12-week study period
  • Non-smoker and not live with someone who smokes
  • No history of asthma
  • Use a short-acting bronchodilator

排除标准

  • 未提供

结局指标

主要结局

Exacerbations

时间窗: 3 months

Number of exacerbations during the 3-month follow-up period

次要结局

  • Physical activity: Total number of steps per day(Up to 3 months)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Vincent S. Fan

Staff Physician

VA Puget Sound Health Care System

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