Trial Outcomes & Findings for Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response (NCT NCT02153359)
NCT ID: NCT02153359
Last Updated: 2019-09-12
Results Overview
Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Approximately 1 month
Results posted on
2019-09-12
Participant Flow
Participant milestones
| Measure |
Air Cleaner Then Sham Air Cleaner
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner Then Air Cleaner
A sham air cleaner will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
Intervention 1 (1 Month)
STARTED
|
11
|
12
|
|
Intervention 1 (1 Month)
COMPLETED
|
11
|
12
|
|
Intervention 1 (1 Month)
NOT COMPLETED
|
0
|
0
|
|
Washout (at Least 1 Month)
STARTED
|
11
|
12
|
|
Washout (at Least 1 Month)
COMPLETED
|
11
|
12
|
|
Washout (at Least 1 Month)
NOT COMPLETED
|
0
|
0
|
|
Intervention 2 (1 Month)
STARTED
|
11
|
12
|
|
Intervention 2 (1 Month)
COMPLETED
|
11
|
10
|
|
Intervention 2 (1 Month)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Air Cleaner Then Sham Air Cleaner
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner Then Air Cleaner
A sham air cleaner will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
Intervention 2 (1 Month)
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
1 participant did not perform spirometry.
Baseline characteristics by cohort
| Measure |
All Participants
n=23 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention (experimental arm) or sham air cleaner (sham comparator) will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. After this one month intervention period, participants will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the other arm.
|
|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 8.8 • n=23 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
African American
|
18 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Non-African American
|
5 Participants
n=23 Participants
|
|
Body mass index
|
40.4 kg/m^2
STANDARD_DEVIATION 8.4 • n=23 Participants
|
|
Education
Not high school graduate
|
3 Participants
n=23 Participants
|
|
Education
High school graduate
|
11 Participants
n=23 Participants
|
|
Education
At least some college
|
9 Participants
n=23 Participants
|
|
Annual household income
<$25,000
|
13 Participants
n=23 Participants
|
|
Annual household income
$25,000-$50,000
|
6 Participants
n=23 Participants
|
|
Annual household income
>$50,000
|
2 Participants
n=23 Participants
|
|
Annual household income
Unreported
|
2 Participants
n=23 Participants
|
|
Health insurance
Private
|
8 Participants
n=23 Participants
|
|
Health insurance
Public
|
14 Participants
n=23 Participants
|
|
Health insurance
Other
|
1 Participants
n=23 Participants
|
|
Atopic status
Atopic
|
20 Participants
n=23 Participants
|
|
Atopic status
Not atopic
|
3 Participants
n=23 Participants
|
|
Asthma severity
Mild intermittent
|
6 Participants
n=23 Participants
|
|
Asthma severity
Mild persistent
|
4 Participants
n=23 Participants
|
|
Asthma severity
Moderate persistent
|
11 Participants
n=23 Participants
|
|
Asthma severity
Severe persistent
|
2 Participants
n=23 Participants
|
|
At least 1 emergency department visit for asthma in last year
Yes
|
7 Participants
n=23 Participants
|
|
At least 1 emergency department visit for asthma in last year
No
|
16 Participants
n=23 Participants
|
|
Asthma medication use
Albuterol only
|
13 participants
n=23 Participants
|
|
Asthma medication use
Inhaled corticosteroid
|
8 participants
n=23 Participants
|
|
Asthma medication use
Leukotriene modifier
|
3 participants
n=23 Participants
|
|
Asthma medication use
Oral corticosteroids
|
1 participants
n=23 Participants
|
|
Lung function
Pre-bronchodilator FEV1 % predicted
|
92.7 percentage
STANDARD_DEVIATION 26.9 • n=22 Participants • 1 participant did not perform spirometry.
|
|
Lung function
Pre-bronchodilator FVC % predicted
|
102.6 percentage
STANDARD_DEVIATION 27.7 • n=22 Participants • 1 participant did not perform spirometry.
|
|
Lung function
Pre-bronchodilator FEV1/FVC
|
74 percentage
STANDARD_DEVIATION 9 • n=22 Participants • 1 participant did not perform spirometry.
|
|
Presence of detectable indoor air nicotine concentration
|
0.58 ug/m^3
STANDARD_DEVIATION 1.08 • n=23 Participants
|
|
General condition of home
1 - Extremely poor: no evidence of cleaning
|
1 Participants
n=19 Participants • 4 participants did not have home inspections to determine the general condition of the home.
|
|
General condition of home
2 - Poor: minimal cleaning
|
2 Participants
n=19 Participants • 4 participants did not have home inspections to determine the general condition of the home.
|
|
General condition of home
3 - Average: some cleaning
|
8 Participants
n=19 Participants • 4 participants did not have home inspections to determine the general condition of the home.
|
|
General condition of home
4 - Above average: clean without much clutter
|
6 Participants
n=19 Participants • 4 participants did not have home inspections to determine the general condition of the home.
|
|
General condition of home
5 - Excellent: very clean, organized
|
2 Participants
n=19 Participants • 4 participants did not have home inspections to determine the general condition of the home.
|
PRIMARY outcome
Timeframe: Approximately 1 monthPopulation: Particulate matter data was missing for 3 participants -- 2 participants were lost to follow-up in the air cleaner group and 1 in the sham air cleaner group had corrupt particulate matter data due to dysfunctional air quality monitoring device.
Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.
Outcome measures
| Measure |
Air Cleaner
n=21 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=22 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
PM2.5 Concentration (ug/m^3)
|
18.95 ug/m^3
Standard Deviation 30.09
|
32.73 ug/m^3
Standard Deviation 37.70
|
PRIMARY outcome
Timeframe: Approximately 1 monthPopulation: 2 participants were lost to follow-up in the air cleaner group. 8 participants in the sham air cleaner group had invalid PM10 data and thus could not have PM2.5-10 data calculated.
Coarse particulate matter (PM2.5-10) concentration as assessed by a passive filter placed in the participant's home.
Outcome measures
| Measure |
Air Cleaner
n=21 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=15 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
PM2.5-10 Concentration (ug/m^3)
|
7.89 ug/m^3
Standard Deviation 21.72
|
13.93 ug/m^3
Standard Deviation 9.71
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 3 participants did not report their symptoms.
The number of reported days without daytime asthma symptoms (symptom-free days) as based on daily symptom diaries recorded by the patient.
Outcome measures
| Measure |
Air Cleaner
n=22 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=21 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
Number of Symptom-free Days
|
4 days
Standard Deviation 2.55
|
3.76 days
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 3 participants did not report their activity limitations.
Number of reported days with activity limitations due to asthma symptoms.
Outcome measures
| Measure |
Air Cleaner
n=22 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=21 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
Number of Days With Activity Limitations
|
2.48 days
Standard Deviation 2.68
|
2.33 days
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: 7 nightsPopulation: 3 participants did not report the number of nights disrupted due to asthma symptoms.
The number of nights spent sleeping that was disrupted due to asthma symptoms.
Outcome measures
| Measure |
Air Cleaner
n=22 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=21 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
Number of Nights Disrupted by Asthma Symptoms
|
0.95 nights
Standard Deviation 1.91
|
1.14 nights
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 3 participants did not report the number of days of school/work missed due to asthma symptoms.
The number of days of school or work missed due to asthma symptoms.
Outcome measures
| Measure |
Air Cleaner
n=22 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=21 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
Number of Days of School/Work Missed Due to Asthma Symptoms
|
0.10 days
Standard Deviation 0.44
|
0.24 days
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 3 participants did not report the number of days of unscheduled doctor visits due to asthma symptoms.
The number of days of unscheduled, urgent visits to the office, urgent care or emergency department due to asthma symptoms.
Outcome measures
| Measure |
Air Cleaner
n=22 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=21 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms
|
0.19 days
Standard Deviation 0.87
|
0.14 days
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Approximately 1 monthPopulation: A total of 9 ACCI questionnaires were not accessible. There is no data for 4 participants in the air cleaner group and 5 participants in the sham air cleaner group.
The ACCI is a validated clinical tool that measures asthma disease status during routine health care and is valid for use in both black and white populations. The sum of each of the 5 ACCI asthma control domains results in a final ACCI score ranging from 0 (better control) to 19 (worse control).
Outcome measures
| Measure |
Air Cleaner
n=19 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=18 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI)
|
2.44 units on a scale
Standard Deviation 2.59
|
2.50 units on a scale
Standard Deviation 3.43
|
SECONDARY outcome
Timeframe: Approximately 1 monthPopulation: A total of 9 AQLQ questionnaires were not accessible. There is no data for 4 participants in the air cleaner group and 5 participants in the sham air cleaner group.
The AQLQ is validated clinical tool to assess asthma-specific health-related quality of life instrument that taps both physical and emotional impact of disease. Scores range from 1-7, with higher scores indicating better quality of life.
Outcome measures
| Measure |
Air Cleaner
n=19 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=18 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
|
|---|---|---|
|
Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ)
|
6.15 units on a scale
Standard Deviation 0.84
|
6.06 units on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Approximately 1 monthPopulation: 2 participants were lost to follow-up in the air cleaner group and 1 in the sham air cleaner group had corrupt data that could not be accessed.
Indoor air nicotine concentration as assessed by a passive filter placed in the participant's home.
Outcome measures
| Measure |
Air Cleaner
n=21 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
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Sham Air Cleaner
n=22 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
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|---|---|---|
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Air Nicotine Concentration (ug/m^3)
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0.37 ug/m^3
Standard Deviation 0.99
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0.37 ug/m^3
Standard Deviation 0.80
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SECONDARY outcome
Timeframe: 1 DayPopulation: 2 participants were lost to follow up and 6 participants declined bronchoscopies.
The percentage of neutrophils in the bronchoalveolar lavage cell count.
Outcome measures
| Measure |
Air Cleaner
n=20 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
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Sham Air Cleaner
n=18 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
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|---|---|---|
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Bronchoalveolar Lavage Differential Neutrophil Count
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1.49 percentage of total cell count
Standard Deviation 0.83
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2.10 percentage of total cell count
Standard Deviation 2.23
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SECONDARY outcome
Timeframe: 1 dayPopulation: 2 participants were lost to follow up and 6 participants declined bronchoscopies.
The eosinophil percentage in the bronchoalveolar lavage cell count differential.
Outcome measures
| Measure |
Air Cleaner
n=20 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=18 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
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|---|---|---|
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Bronchoalveolar Lavage Differential Eosinophil Count
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0.26 percentage of total cell count
Standard Deviation 0.35
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0.45 percentage of total cell count
Standard Deviation 0.44
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SECONDARY outcome
Timeframe: 1 dayPopulation: 14 participants had missing spirometry data.
Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry
Outcome measures
| Measure |
Air Cleaner
n=16 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=16 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
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|---|---|---|
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Pre-bronchodilator Forced Vital Capacity (Litres)
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3.43 litres
Standard Deviation 1.29
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3.52 litres
Standard Deviation 1.27
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SECONDARY outcome
Timeframe: 1 dayPopulation: 14 participants had missing spirometry data.
The pre-bronchodilator forced expiratory volume in 1 second (FEV1) as assessed by spirometry.
Outcome measures
| Measure |
Air Cleaner
n=16 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=16 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
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|---|---|---|
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Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)
|
2.55 litres
Standard Deviation 0.92
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2.60 litres
Standard Deviation 0.83
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SECONDARY outcome
Timeframe: 1 dayPopulation: 14 participants had missing spirometry data.
The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.
Outcome measures
| Measure |
Air Cleaner
n=16 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
|
Sham Air Cleaner
n=16 Participants
A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
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|---|---|---|
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FEV1 Percentage of FVC
|
0.75 percentage of forced vital capacity
Standard Deviation 0.07
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0.75 percentage of forced vital capacity
Standard Deviation 0.08
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Adverse Events
Air Cleaner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Air Cleaner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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