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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: No intervention was used in this study, this was an observational study

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.

• Study Type: Observational
• Enrollment (Actual): 35

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic obstructive pulmonary disease at VA Puget Sound Health Care System in Seattle, WA

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbations	Number of exacerbations during the 3-month follow-up period	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity: Total number of steps per day	An Omron pedometer was used by patients for 7 days at baseline, week 4, week 10 during the 3 month follow-up period.	Up to 3 months

Collaborators and Investigators

• Sponsor: VA Puget Sound Health Care System
• Investigators: Principal Investigator: Vincent Fan, MD MPH, VA Puget Sound HCS, Seattle, WA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 19, 2016
• First Posted (Estimate): January 22, 2016

Study Record Updates

• Last Update Posted (Estimate): January 22, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: VA HSR&D PPO 10-299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No