Residential Cleaning of Indoor Air to Reduce Acute Exacerbations of COPD (CARE): A Pilot Randomized Crossover Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Mean Change in Daily Steps
Study Overview
Brief Summary
This study looks at whether air cleaning devices put in the bedroom and living room of your home could reduce the irritation of your lungs and body that is caused by indoor air pollution. While participating in this study there will be two, 2 month long study segments (Study Period 1 and Study Period 2) where the air filter units, placed in your living room and bedroom windows, will be turned on at your home.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •severe COPD (FEV1 < 50%)
- •live in Monroe County
- •referred for pulmonary rehabilitation
- •suffered from an AECOPD in the past year
- •have standard sized windows in their bedroom and living room amenable to installation of the HEPAirX® device
- •expect to sleep each night of the 4 months (2 months of Period 1, and 2 months of period 2) in either their bedroom or living room for at least 6 hours/night, and not use other air filtering devices during the study
Exclusion Criteria
- •under age 18
- •smoking at the time of their prior COPD exacerbation
- •current smokers
- •those who live with an active smoker
- •those with an occupation that has a high pollutant exposure (e.g. professional drivers)
- •those who already have a home air filtration device (other than basic furnace filter)
Arms & Interventions
HEPAirX air filter
Intervention: HEPAirX air filter (Device)
Control air filter
Intervention: control air filter (Device)
Outcomes
Primary Outcomes
Mean Change in Daily Steps
Time Frame: week 0 to week 8
Steps will be measured using a Fitbit step counter.
Mean Change in St. George Respiratory Questionnaire
Time Frame: week 19 to week 31
The St. Georges Respiratory Questionnaire (SGRQ) is an established, clinically relevant measure of respiratory symptoms, activity level, and impacts on daily life, and is a measure of functional status regularly used and validated in COPD patient populations. The questionnaire is a fixed format 50 item survey completed by the study subject asking questions in three parts: 1) levels of symptomatology including frequency of wheezing, cough, sputum production, and breathlessness, including the duration of episodes of wheeze and breathlessness, 2) physical activities that may be caused or are limited by breathlessness, and 3) impacts of these symptoms. It is a self-assessment of respiratory symptoms and functional status, and provides a quantification of the impacts of airflow limitation on health and well-being. The scores range from 0 to 100 with higher number indicating worse outcomes.
Mean Change in Daily Step
Time Frame: 11 weeks to 19 weeks
Steps will be measured using a Fitbit step counter.
Mean Change in St. George Respiratory Questionnaire
Time Frame: baseline to 8 weeks
The St. Georges Respiratory Questionnaire (SGRQ) is an established, clinically relevant measure of respiratory symptoms, activity level, and impacts on daily life, and is a measure of functional status regularly used and validated in COPD patient populations. The questionnaire is a fixed format 50 item survey completed by the study subject asking questions in three parts: 1) levels of symptomatology including frequency of wheezing, cough, sputum production, and breathlessness, including the duration of episodes of wheeze and breathlessness, 2) physical activities that may be caused or are limited by breathlessness, and 3) impacts of these symptoms. It is a self-assessment of respiratory symptoms and functional status, and provides a quantification of the impacts of airflow limitation on health and well-being. The scores range from 0 to 100 with higher number indicating worse outcomes.
Mean Change in St. George Respiratory Questionnaire
Time Frame: 11 weeks to 19 weeks
The St. Georges Respiratory Questionnaire (SGRQ) is an established, clinically relevant measure of respiratory symptoms, activity level, and impacts on daily life, and is a measure of functional status regularly used and validated in COPD patient populations. The questionnaire is a fixed format 50 item survey completed by the study subject asking questions in three parts: 1) levels of symptomatology including frequency of wheezing, cough, sputum production, and breathlessness, including the duration of episodes of wheeze and breathlessness, 2) physical activities that may be caused or are limited by breathlessness, and 3) impacts of these symptoms. It is a self-assessment of respiratory symptoms and functional status, and provides a quantification of the impacts of airflow limitation on health and well-being. The scores range from 0 to 100 with higher number indicating worse outcomes.
Secondary Outcomes
- Mean Number of Outpatient and Inpatient Visits for Chronic Obstructive Pulmonary Disorder Exacerbations(baseline to week 31)
- Mean Plasma C-reactive Protein Level(week 0 to week 19)
- Mean Number of Outpatient and Inpatient Visit for Chronic Obstructive Pulmonary Disorder Exacerbations(baseline to week 31)
Investigators
Dan Croft
Assistant Professor
University of Rochester