Chronic Obstructive Pulmonary Disease
Conditions
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.
Interventions
DEVICEHEPAirX air filter
It is a trademarked, patented (U.S. Patent # 7,802,443), U.S. FDA approved Class II medical re-circulating air cleaner, built by Air Innovations, Inc. (North Syracuse, NY) to provide improved indoor air quality in the bedrooms of asthmatic children. Units to be used in the proposed study have a 99.97% efficient filter for particles 0.3 µm in size. The device provides a clean air delivery rate (CADR) of 9 per hour with 1.8 of them being outdoor air.
DEVICEcontrol air filter
A placebo mode was added to the HEPAirX to provide only recirculation (without filtration or ventilation using outdoor air) and temperature control of the room air. The placebo filter is made of metal.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in St. George Respiratory Questionnaire | 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 Daily Steps | week 0 to week 8 | Steps will be measured using a Fitbit step counter. |
| Mean Change in Daily Step | 11 weeks to 19 weeks | Steps will be measured using a Fitbit step counter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 69.44 years STANDARD_DEVIATION 4.93 |
| Mean smoking pack years | 47.83 years STANDARD_DEVIATION 17.59 |
| Number of participants with a psychiatric condition | 9 Participants |
| Number of participants with Asthma | 1 Participants |
| Number of participants with chronic heart failure | 3 Participants |
| Number of participants with chronic kidney disease | 2 Participants |
| Number of participants with COPD symptoms | 9 Participants |
| number of participants with diabetes | 2 Participants |
| Number of participants with obstructive sleep apnea | 4 Participants |
| Number of participants with sinus disease | 2 Participants |
| Number of participants with vitamin D deficiency | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Mean Change in Daily Step
Steps will be measured using a Fitbit step counter.
Time frame: 11 weeks to 19 weeks
Population: Data was not collected on one subject in the HEPAirX air filter arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEPAirX Air Filter | Mean Change in Daily Step | 39.41 steps per day | Standard Deviation 78.66 |
| Control Air Filter | Mean Change in Daily Step | -3.85 steps per day | Standard Deviation 100.67 |
Primary
Mean Change in Daily Steps
Steps will be measured using a Fitbit step counter.
Time frame: week 0 to week 8
Population: Data was not collected on one subject in the HEPAirX air filter arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEPAirX Air Filter | Mean Change in Daily Steps | 6.43 steps per day | Standard Deviation 111.47 |
| Control Air Filter | Mean Change in Daily Steps | -16.57 steps per day | Standard Deviation 23.98 |
Primary
Mean Change in St. George Respiratory Questionnaire
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.
Time frame: week 19 to week 31
Population: Data was collected on only three patients made it to week 31, two in the placebo arm and one in the filter arm. Therefore an measure of dispersion/precision could not be provided.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| HEPAirX Air Filter | Mean Change in St. George Respiratory Questionnaire | 21.3 score on a scale |
| Control Air Filter | Mean Change in St. George Respiratory Questionnaire | 1.14 score on a scale |
Primary
Mean Change in St. George Respiratory Questionnaire
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.
Time frame: baseline to 8 weeks
Population: Baseline data was not collected on one subject in the HEPAirX air filter arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEPAirX Air Filter | Mean Change in St. George Respiratory Questionnaire | -12.5 score on a scale | Standard Deviation 20 |
| Control Air Filter | Mean Change in St. George Respiratory Questionnaire | -0.45 score on a scale | Standard Deviation 7.47 |
Primary
Mean Change in St. George Respiratory Questionnaire
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.
Time frame: 11 weeks to 19 weeks
Population: Data was not collected on one subject in the HEPAirX air filter arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEPAirX Air Filter | Mean Change in St. George Respiratory Questionnaire | 9.65 score on a scale | Standard Deviation 13.4 |
| Control Air Filter | Mean Change in St. George Respiratory Questionnaire | 1.68 score on a scale | Standard Deviation 1.88 |
Secondary
Mean Number of Outpatient and Inpatient Visit for Chronic Obstructive Pulmonary Disorder Exacerbations
The number of exacerbations will be measured using patient report
Time frame: baseline to week 31
Population: Data was not collected for this outcome measure.
Secondary
Mean Number of Outpatient and Inpatient Visits for Chronic Obstructive Pulmonary Disorder Exacerbations
The number of exacerbations will be measured using retrospective review of Patient charts.
Time frame: baseline to week 31
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEPAirX Air Filter | Mean Number of Outpatient and Inpatient Visits for Chronic Obstructive Pulmonary Disorder Exacerbations | 1 visits | Standard Deviation 0 |
| Control Air Filter | Mean Number of Outpatient and Inpatient Visits for Chronic Obstructive Pulmonary Disorder Exacerbations | 1 visits | Standard Deviation 0 |
Secondary
Mean Plasma C-reactive Protein Level
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.
Time frame: week 0 to week 19
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEPAirX Air Filter | Mean Plasma C-reactive Protein Level | 9.75 mg/L | Standard Deviation 13.84 |
| Control Air Filter | Mean Plasma C-reactive Protein Level | 5.9 mg/L | Standard Deviation 7.72 |