Smog Induced Indoor Air Pollution in Homes of Chronic Obstructive Pulmonary Disease Patients.

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Smog Induced Indoor Air Pollution in Homes of Chronic Obstructive Pulmonary Disease Patients: Effectiveness of Controls

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02775487
• Other study ID #: ST-MU-UT 2012
• Status: Withdrawn
• Phase: N/A
• First received: January 23, 2012
• Last updated: September 29, 2016
• Start date: January 2013
• Est. completion date: January 2013

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Air quality measures at week 5	Air samples taken from the home	week 5 of study	No
Secondary	Change in Borg scale for breathlessness from week 1 to week 5	Scale on which participant rates perceived breathlessness	week 1 of study, week 2 of study and week 5 of study	No
Secondary	Change in vital signs from week 1 to week 5	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	No
Secondary	Change in Air quality measures from week 1 to week 5	Change in Air quality measures from week 1 to week 5	week 1 and week 2 of the study	No