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Completed

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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Key information

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

No intervention was used in this study, this was an observational study

Other

Primary outcomes

  1. Exacerbations

    Time frame: 3 months

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

Secondary outcomes

  1. 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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