- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02775487
Smog Induced Indoor Air Pollution in Homes of Chronic Obstructive Pulmonary Disease Patients.
September 29, 2016 updated by: University of Missouri-Columbia
Smog Induced Indoor Air Pollution in Homes of Chronic Obstructive Pulmonary Disease Patients: Effectiveness of Controls
Primary objective of this project is to measure the impact of passive control and active control systems on indoor pollution that is directly or indirectly related to ambient air pollution (smog).
The first goal will be to measure baseline parameters for 50 homes, including information about the building, ventilation characteristics, pollution levels (indoors and outdoors), and occupant survey information.
In a subset of these homes, either passive or active control systems will be installed and the impact of these systems on indoor concentrations.
Participants will be enrolled on a rolling basis (5-15 persons studied at a given point in time) over a 16-month period.
Participants will be followed for approximately 5 weeks and data obtained at three points in time: at enrollment (day 1 of study), after 1 week (baseline verification) and after four weeks with the control system in the home (at the end of study week 5).
Study Overview
Status
Withdrawn
Conditions
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a degenerative lung disease resulting in lower lung function characterized by an obstruction to airflow.
COPD is an umbrella term for two disease processes: chronic bronchitis and emphysema.
It is currently the 4th leading cause of death in the United States.
Approximately 14 million Americans are known to suffer from COPD; however, it is estimated that as many as 24 million Americans may have some form of one or both of the diseases (Centers for Disease Control, 2011).
The primary risk factor for developing COPD is cigarette smoking; other factors include exposure to air pollution, occupational dusts and chemicals, and lower socioeconomic status.
Poverty has been identified as a risk factor for COPD but the aspects related to poverty that increase the risk of COPD are unclear (GOLD, 2011).
Lower education level and household income has been noted to relate to increased severity of COPD (Eisner, Blanc, Omachi, Yelin, Sidney, Katz, et al, 2011).
An American Lung Association survey found that over half of those diagnosed with COPD reported that their condition limits their ability to perform activities of daily living, including activities in the home (American Lung Association, 2009).
As air pollution can lead to an exacerbation of COPD symptoms and precipitate emergency room visits and hospitalization, minimizing pollution in indoor air may be a key component of disease management and decreasing health care costs.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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Columbia, Missouri, United States, 65211
- University of Missouri
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
Study participants will be recruited from pulmonary rehabilitation centers in St. Louis, MO.
Potential participants will be screened to ascertain eligibility based on diagnosis and stage of disease progression.
Description
Inclusion Criteria:
- diagnosis of COPD (stage III or IV); adults over the age of 18 years
Exclusion Criteria:
- Children (persons under age 18), fetuses, neonates, pregnant women, prisoners
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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COPD and air quality
Persons enrolled in the study will have been diagnosed with Stage III or IV COPD and samples of air taken from their home environment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Air quality measures at week 5
Time Frame: week 5 of study
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Air samples taken from the home
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week 5 of study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Borg scale for breathlessness from week 1 to week 5
Time Frame: week 1 of study, week 2 of study and week 5 of study
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Scale on which participant rates perceived breathlessness
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week 1 of study, week 2 of study and week 5 of study
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Change in vital signs from week 1 to week 5
Time Frame: week 1 of study, week 2 of study and week 5 of study
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Heart rate, respiratory rate, blood pressure, oxygen saturation (SpO2) via pulse oximetry, bedside spirometry
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week 1 of study, week 2 of study and week 5 of study
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Change in Air quality measures from week 1 to week 5
Time Frame: week 1 and week 2 of the study
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Change in Air quality measures from week 1 to week 5
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week 1 and week 2 of the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shawna L Strickland, PhD, RRT, University of Missouri-Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
January 23, 2012
First Submitted That Met QC Criteria
May 13, 2016
First Posted (Estimate)
May 17, 2016
Study Record Updates
Last Update Posted (Estimate)
September 30, 2016
Last Update Submitted That Met QC Criteria
September 29, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST-MU-UT 2012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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