Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Location and Timing of Inhaler Use, Exacerbations and Physical Activity in Chronic Obstructive Pulmonary Disease
Verified date | January 2016 |
Source | VA Puget Sound Health Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
VA Puget Sound Health Care System |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exacerbations | Number of exacerbations during the 3-month follow-up period | 3 months | No |
Secondary | 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 | No |
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