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Clinical Trials/NCT02661321
NCT02661321
Completed
Not Applicable

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

VA Puget Sound Health Care System0 sites35 target enrollmentDecember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
VA Puget Sound Health Care System
Enrollment
35
Primary Endpoint
Exacerbations
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
January 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vincent S. Fan

Staff Physician

VA Puget Sound Health Care System

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Exacerbations

Time Frame: 3 months

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

Secondary Outcomes

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

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