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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02661321
Enrollment
35
Registered
2016-01-22
Start date
2011-12-31
Completion date
2014-01-31
Last updated
2016-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

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

Sponsors

VA Puget Sound Health Care System
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Exacerbations3 monthsNumber of exacerbations during the 3-month follow-up period

Secondary

MeasureTime frameDescription
Physical activity: Total number of steps per dayUp to 3 monthsAn Omron pedometer was used by patients for 7 days at baseline, week 4, week 10 during the 3 month follow-up period.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026