Trial Outcomes & Findings for Residential Cleaning of Indoor Air to Protect COPD Patients (NCT NCT03750292)
NCT ID: NCT03750292
Last Updated: 2022-06-01
Results Overview
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.
COMPLETED
NA
9 participants
baseline to 8 weeks
2022-06-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (Baseline to 8 Weeks)
STARTED
|
5
|
4
|
|
First Intervention (Baseline to 8 Weeks)
COMPLETED
|
5
|
4
|
|
First Intervention (Baseline to 8 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Washout (3 Weeks)
STARTED
|
5
|
4
|
|
Washout (3 Weeks)
COMPLETED
|
5
|
4
|
|
Washout (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (11 to 19 Weeks)
STARTED
|
5
|
4
|
|
Second Intervention (11 to 19 Weeks)
COMPLETED
|
5
|
4
|
|
Second Intervention (11 to 19 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Residential Cleaning of Indoor Air to Protect COPD Patients
Baseline characteristics by cohort
| Measure |
All Participants
n=9 Participants
All participants
|
|---|---|
|
Age, Continuous
|
69.44 years
STANDARD_DEVIATION 4.93 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
|
Number of participants with obstructive sleep apnea
|
4 Participants
n=99 Participants
|
|
Number of participants with Asthma
|
1 Participants
n=99 Participants
|
|
Number of participants with chronic heart failure
|
3 Participants
n=99 Participants
|
|
number of participants with diabetes
|
2 Participants
n=99 Participants
|
|
Number of participants with chronic kidney disease
|
2 Participants
n=99 Participants
|
|
Number of participants with sinus disease
|
2 Participants
n=99 Participants
|
|
Number of participants with vitamin D deficiency
|
0 Participants
n=99 Participants
|
|
Number of participants with a psychiatric condition
|
9 Participants
n=99 Participants
|
|
Mean smoking pack years
|
47.83 years
STANDARD_DEVIATION 17.59 • n=99 Participants
|
|
Number of participants with COPD symptoms
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline to 8 weeksPopulation: Baseline data was not collected on one subject in the HEPAirX air filter arm.
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.
Outcome measures
| Measure |
HEPAirX Air Filter
n=4 Participants
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.
|
Control Air Filter
n=4 Participants
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.
|
|---|---|---|
|
Mean Change in St. George Respiratory Questionnaire
|
-12.5 score on a scale
Standard Deviation 20.00
|
-0.45 score on a scale
Standard Deviation 7.47
|
PRIMARY outcome
Timeframe: 11 weeks to 19 weeksPopulation: Data was not collected on one subject in the HEPAirX air filter arm.
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.
Outcome measures
| Measure |
HEPAirX Air Filter
n=4 Participants
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.
|
Control Air Filter
n=4 Participants
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.
|
|---|---|---|
|
Mean Change in St. George Respiratory Questionnaire
|
9.65 score on a scale
Standard Deviation 13.4
|
1.68 score on a scale
Standard Deviation 1.88
|
PRIMARY outcome
Timeframe: week 19 to week 31Population: 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.
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.
Outcome measures
| Measure |
HEPAirX Air Filter
n=1 Participants
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.
|
Control Air Filter
n=2 Participants
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.
|
|---|---|---|
|
Mean Change in St. George Respiratory Questionnaire
|
21.3 score on a scale
Interval 21.3 to 21.3
|
1.14 score on a scale
Interval -6.28 to 8.55
|
PRIMARY outcome
Timeframe: week 0 to week 8Population: Data was not collected on one subject in the HEPAirX air filter arm.
Steps will be measured using a Fitbit step counter.
Outcome measures
| Measure |
HEPAirX Air Filter
n=4 Participants
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.
|
Control Air Filter
n=4 Participants
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.
|
|---|---|---|
|
Mean Change in Daily Steps
|
6.43 steps per day
Standard Deviation 111.47
|
-16.57 steps per day
Standard Deviation 23.98
|
PRIMARY outcome
Timeframe: 11 weeks to 19 weeksPopulation: Data was not collected on one subject in the HEPAirX air filter arm.
Steps will be measured using a Fitbit step counter.
Outcome measures
| Measure |
HEPAirX Air Filter
n=4 Participants
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.
|
Control Air Filter
n=4 Participants
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.
|
|---|---|---|
|
Mean Change in Daily Step
|
39.41 steps per day
Standard Deviation 78.66
|
-3.85 steps per day
Standard Deviation 100.67
|
SECONDARY outcome
Timeframe: week 0 to week 19Plasma 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.
Outcome measures
| Measure |
HEPAirX Air Filter
n=9 Participants
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.
|
Control Air Filter
n=9 Participants
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.
|
|---|---|---|
|
Mean Plasma C-reactive Protein Level
|
9.75 mg/L
Standard Deviation 13.84
|
5.9 mg/L
Standard Deviation 7.72
|
SECONDARY outcome
Timeframe: baseline to week 31The number of exacerbations will be measured using retrospective review of Patient charts.
Outcome measures
| Measure |
HEPAirX Air Filter
n=5 Participants
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.
|
Control Air Filter
n=4 Participants
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.
|
|---|---|---|
|
Mean Number of Outpatient and Inpatient Visits for Chronic Obstructive Pulmonary Disorder Exacerbations
|
1 visits
Standard Deviation 0
|
1 visits
Standard Deviation 0
|
SECONDARY outcome
Timeframe: baseline to week 31Population: Data was not collected for this outcome measure.
The number of exacerbations will be measured using patient report
Outcome measures
Outcome data not reported
Adverse Events
HEPAirX Air Filter
Control Air Filter
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place