Clinical Trials Directory

Trials / Completed

CompletedNCT02661321

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

Status
Completed
Phase
Study type
Observational
Enrollment
35 (actual)
Sponsor
VA Puget Sound Health Care System · Federal
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNo intervention was used in this study, this was an observational study

Timeline

Start date
2011-12-01
Primary completion
2014-01-01
Completion
2014-01-01
First posted
2016-01-22
Last updated
2016-01-22

Source: ClinicalTrials.gov record NCT02661321. Inclusion in this directory is not an endorsement.