Residential Cleaning of Indoor Air to Protect COPD Patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: HEPAirX air filterDevice: control air filter
- Registration Number
- NCT03750292
- Lead Sponsor
- University of Rochester
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description HEPAirX air filter HEPAirX air filter - Control air filter control air filter -
- Primary Outcome Measures
Name Time Method Mean Change in Daily Steps week 0 to week 8 Steps will be measured using a Fitbit step counter.
Mean Change in St. George Respiratory Questionnaire 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 11 weeks to 19 weeks Steps will be measured using a Fitbit step counter.
- Secondary Outcome Measures
Name Time Method Mean Number of Outpatient and Inpatient Visits for Chronic Obstructive Pulmonary Disorder Exacerbations baseline to week 31 The number of exacerbations will be measured using retrospective review of Patient charts.
Mean Plasma C-reactive Protein Level week 0 to week 19 Plasma C-reactive protein (CRP) is a measure of systemic inflammation, and is an acute phase protein known to increase in the hours and days following an inflammatory stimulus. C-reactive protein will be measured in plasma obtained from whole blood using standard procedures.
Mean Number of Outpatient and Inpatient Visit for Chronic Obstructive Pulmonary Disorder Exacerbations baseline to week 31 The number of exacerbations will be measured using patient report
Trial Locations
- Locations (1)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States