Clinical trial NCT02775487: Smog Induced Indoor Air Pollution in Homes of Chronic Obstructive Pulmonary Disease Patients.
Official title: Smog Induced Indoor Air Pollution in Homes of Chronic Obstructive Pulmonary Disease Patients: Effectiveness of Controls
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Air quality
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
First posted: 2016-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Air quality measures at week 5
timeFrame: week 5 of study
Secondary outcomes:
measure: Change in Borg scale for breathlessness from week 1 to week 5
timeFrame: week 1 of study, week 2 of study and week 5 of study
measure: Change in vital signs from week 1 to week 5
timeFrame: week 1 of study, week 2 of study and week 5 of study
measure: Change in Air quality measures from week 1 to week 5
timeFrame: week 1 and week 2 of the study
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Shawna L Strickland, PhD, RRT
role: PRINCIPAL_INVESTIGATOR
References: