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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEPAirX air filter | Experimental |
| |
| Control air filter | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEPAirX air filter | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 8 weeks |
| 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. | 11 weeks to 19 weeks |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 0 to week 19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Filtration Followed by Placebo | Participants had a HEPAir X air filter in the home for 8 weeks followed by a 3 week washout period and then a placebo period of 8 weeks where the HEPAirX provided only recirculation without filtration or ventilation using outdoor air. HEPAirX 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. |
| FG001 | Placebo Followed by Filtration | Participants had a placebo period of 8 weeks where the HEPAirX provided only recirculation without filtration or ventilation using outdoor airfilter in the home followed by a 3 week washout period and then the HEPAirX air filter for 8 weeks. HEPAirX 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Baseline to 8 Weeks) |
| |||||||||||||
| Washout (3 Weeks) |
| |||||||||||||
| Second Intervention (11 to 19 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Baseline data was not collected on one subject in the HEPAirX air filter arm. | Posted | Mean | Standard Deviation | score on a scale | baseline to 8 weeks |
|
19 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HEPAirX Air Filter | HEPAirX 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Croft | University of Rochester | (585) 275-4861 | daniel_croft@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2019 | Mar 22, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2019 | Apr 12, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| control air filter | Device | 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. |
|
| week 19 to week 31 |
| Mean Change in Daily Steps | Steps will be measured using a Fitbit step counter. | week 0 to week 8 |
| Mean Change in Daily Step | Steps will be measured using a Fitbit step counter. | 11 weeks to 19 weeks |
| 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. |
| baseline to week 31 |
| Mean Number of Outpatient and Inpatient Visit for Chronic Obstructive Pulmonary Disorder Exacerbations | The number of exacerbations will be measured using patient report | baseline to week 31 |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of participants with obstructive sleep apnea | Count of Participants | Participants |
|
| Number of participants with Asthma | Count of Participants | Participants |
|
| Number of participants with chronic heart failure | Count of Participants | Participants |
|
| number of participants with diabetes | Count of Participants | Participants |
|
| Number of participants with chronic kidney disease | Count of Participants | Participants |
|
| Number of participants with sinus disease | Count of Participants | Participants |
|
| Number of participants with vitamin D deficiency | Count of Participants | Participants |
|
| Number of participants with a psychiatric condition | Count of Participants | Participants |
|
| Mean smoking pack years | Mean | Standard Deviation | years |
|
| Number of participants with COPD symptoms | Count of Participants | Participants |
|
| OG000 | HEPAirX Air Filter | HEPAirX 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. |
| OG001 | Control Air Filter | control 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. |
|
|
| 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. | Data was not collected on one subject in the HEPAirX air filter arm. | Posted | Mean | Standard Deviation | score on a scale | 11 weeks to 19 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Full Range | score on a scale | week 19 to week 31 |
|
|
|
| Primary | Mean Change in Daily Steps | Steps will be measured using a Fitbit step counter. | Data was not collected on one subject in the HEPAirX air filter arm. | Posted | Mean | Standard Deviation | steps per day | week 0 to week 8 |
|
|
|
| Primary | Mean Change in Daily Step | Steps will be measured using a Fitbit step counter. | Data was not collected on one subject in the HEPAirX air filter arm. | Posted | Mean | Standard Deviation | steps per day | 11 weeks to 19 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/L | week 0 to week 19 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | visits | baseline to week 31 |
|
|
|
| Secondary | Mean Number of Outpatient and Inpatient Visit for Chronic Obstructive Pulmonary Disorder Exacerbations | The number of exacerbations will be measured using patient report | Data was not collected for this outcome measure. | Posted | baseline to week 31 |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Control Air Filter | control 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |