Chronic Obstructive Pulmonary DiseaseNCT02661321
Location and Timing of Inhaler Use, Exacerbations and Physical Activity in Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by VA Puget Sound Health Care System.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic obstructive pulmonary disease at VA Puget Sound Health Care System in Seattle, WA
Who may be able to join
- 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
Who cannot join
None listed.
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- No intervention was used in this study, this was an observational study
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was used in this study, this was an observational studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbations
Number of exacerbations during the 3-month follow-up period
Measured: 3 months
Secondary outcomes (1)
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startDec 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Vincent S. Fan, VA Puget Sound Health Care System
- Investigators
- Vincent Fan, MD MPH, Principal investigator, VA Puget Sound HCS, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661321
- Sponsor's protocol ID
- VA HSR&D PPO 10-299
- Status last verified
- Jan 2016
- First submitted
- 13 Jan 2016
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 29035120
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Location and Timing of Inhaler Use, Exacerbations and Physical Activity in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02661321
- Acronym / sponsor ID
- VA HSR&D PPO 10-299
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- Dec 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic obstructive pulmonary disease at VA Puget Sound Health Care System in Seattle, WA
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention was used in this study, this was an observational study | Other | – |
Primary outcome
Exacerbations
Time frame: 3 months
Number of exacerbations during the 3-month follow-up period
1 secondary outcome
Physical activity: Total number of steps per day
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Derived from this study: PubMed 29035120Sumino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Fan, MD MPH principal investigator
VA Puget Sound HCS, Seattle, WA
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by VA Puget Sound Health Care System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbations (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02661321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.