NCT Number: NCT02661321
Location and Timing of Inhaler Use, Exacerbations and Physical Activity in Chronic Obstructive Pulmonary Disease
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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
Time frame: Up to 3 months
An Omron pedometer was used by patients for 7 days at baseline, week 4, week 10 during the 3 month follow-up period.
Sponsors and collaborators
Lead sponsor
VA Puget Sound Health Care System
Fed
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jan 22, 2016
- Registry last updated
- Jan 22, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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