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

NCT ID: NCT02661321

Last Updated: 2016-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Puget Sound Health Care System

FED

Sponsor Role lead

Responsible Party

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Vincent S. Fan

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincent Fan, MD MPH

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound HCS, Seattle, WA

References

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Sumino K, Locke ER, Magzamen S, Gylys-Colwell I, Humblet O, Nguyen HQ, Thomas RM, Fan VS. Use of a Remote Inhaler Monitoring Device to Measure Change in Inhaler Use with Chronic Obstructive Pulmonary Disease Exacerbations. J Aerosol Med Pulm Drug Deliv. 2018 Jun;31(3):191-198. doi: 10.1089/jamp.2017.1383. Epub 2017 Oct 16.

Reference Type DERIVED
PMID: 29035120 (View on PubMed)

Other Identifiers

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VA HSR&D PPO 10-299

Identifier Type: -

Identifier Source: org_study_id

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