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Withdrawn

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

    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Air quality measures at week 5
Time Frame: week 5 of study
Air samples taken from the home
week 5 of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Scale on which participant rates perceived breathlessness
week 1 of study, week 2 of study and week 5 of study
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
Heart rate, respiratory rate, blood pressure, oxygen saturation (SpO2) via pulse oximetry, bedside spirometry
week 1 of study, week 2 of study and week 5 of study
Change in Air quality measures from week 1 to week 5
Time Frame: week 1 and week 2 of the study
Change in Air quality measures from week 1 to week 5
week 1 and week 2 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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.

Clinical Trials on Chronic Obstructive Pulmonary Disease

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