INHALE 2: Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02153359
• Collaborator: National Institute of Environmental Health Sciences (NIEHS) (NIH)
• Enrollment: 23
• Locations: 2
• Arms: 2
• Actual Duration (Months): 55.3
• Patients Per Site: 11.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study is about asthma and how the environment affects asthma. Scientists know that air pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms worse. This research is being done to study how the health of a person with asthma responds to an air cleaner. The investigator hypothesize that an air cleaner will improve the health of persons with asthma.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Device: High Efficiency Particulate Air Cleaner; Device: Sham air cleaner	N/A

Detailed Description

The investigators seek to determine the effect of placing air cleaner devices in the homes of adults with asthma on the adults' asthma health. To this end, the investigators aim to study 40 adults with asthma that are 18-50 years of age and live in Baltimore. Participants will receive either true air cleaners or sham cleaners in a blinded, randomized manner for one month, and then, after a washout period, participants will cross over and receive the other intervention (sham or true cleaner). All participants will have environmental monitoring (personal and in-home) to determine participants' particulate matter exposure, and be followed repeatedly during the 3 month study period for markers of asthma disease, including respiratory symptoms, medication and health care utilization, pulmonary function, systemic markers of inflammation, and bronchoscopic evidence of airway inflammation or epithelial cell dysfunction.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Sep 11, 2018
• Actual Study Completion Date: Sep 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 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.	Device: High Efficiency Particulate Air Cleaner; Device: Sham air cleaner
Sham Comparator: 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 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.	Device: High Efficiency Particulate Air Cleaner; Device: Sham air cleaner

Outcome Measures

Primary Outcome Measures

1. PM2.5 Concentration (ug/m^3) [Approximately 1 month]

   Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.

2. PM2.5-10 Concentration (ug/m^3) [Approximately 1 month]

   Coarse particulate matter (PM2.5-10) concentration as assessed by a passive filter placed in the participant's home.

Secondary Outcome Measures

1. Number of Symptom-free Days [7 days]

   The number of reported days without daytime asthma symptoms (symptom-free days) as based on daily symptom diaries recorded by the patient.

2. Number of Days With Activity Limitations [7 days]

   Number of reported days with activity limitations due to asthma symptoms.

3. Number of Nights Disrupted by Asthma Symptoms [7 nights]

   The number of nights spent sleeping that was disrupted due to asthma symptoms.

4. Number of Days of School/Work Missed Due to Asthma Symptoms [7 days]

   The number of days of school or work missed due to asthma symptoms.

5. Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms [7 days]

   The number of days of unscheduled, urgent visits to the office, urgent care or emergency department due to asthma symptoms.

6. Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI) [Approximately 1 month]

   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).

7. Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ) [Approximately 1 month]

   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.

8. Air Nicotine Concentration (ug/m^3) [Approximately 1 month]

   Indoor air nicotine concentration as assessed by a passive filter placed in the participant's home.

9. Bronchoalveolar Lavage Differential Neutrophil Count [1 Day]

   The percentage of neutrophils in the bronchoalveolar lavage cell count.

10. Bronchoalveolar Lavage Differential Eosinophil Count [1 day]

    The eosinophil percentage in the bronchoalveolar lavage cell count differential.

11. Pre-bronchodilator Forced Vital Capacity (Litres) [1 day]

    Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry

12. Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres) [1 day]

    The pre-bronchodilator forced expiratory volume in 1 second (FEV1) as assessed by spirometry.

13. FEV1 Percentage of FVC [1 day]

    The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18-50 years of age

• Non-smoker (<100 cigarettes in lifetime)

• Physician diagnosis of asthma

• Symptoms of asthma and/or reliever medication use in the past 6 months

• Living in the current residence >= 6 months within Baltimore

• Enrollment in, and completion of, the observational environmental asthma study "Inhale 1"

Exclusion Criteria:

• Current diagnosis of another major pulmonary disease, other significant morbidity

• Pregnancy (as defined by a positive urine pregnancy test at screening of all women of child-bearing potential)

• Planning to relocate residence or activity that necessitates travel away from home for prolonged period of time during the study period

• Current use of an air cleaner in the home

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224
2	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• National Institute of Environmental Health Sciences (NIEHS)

Investigators

• Principal Investigator: Sonali Bose, MD MPH, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 31, 2019

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02153359
• Other Study ID Numbers: NA_00082646; 1K24ES021098-01; K23ES021789
• First Posted: Jun 3, 2014
• Last Update Posted: Sep 12, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Johns Hopkins University: asthma; HEPA; air pollutants; lung function; home environment; respiratory symptoms
• Additional relevant MeSH terms: Asthma

Study Results

Participant Flow

Arm/Group Title	Air Cleaner Then Sham Air Cleaner	Sham Air Cleaner Then Air Cleaner
Arm/Group Description	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.	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.
Period Title: Intervention 1 (1 Month)
STARTED	11	12
COMPLETED	11	12
NOT COMPLETED	0	0
Period Title: Intervention 1 (1 Month)
STARTED	11	12
COMPLETED	11	12
NOT COMPLETED	0	0
Period Title: Intervention 1 (1 Month)
STARTED	11	12
COMPLETED	11	10
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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.
Overall Participants	23
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39 (8.8)
Sex: Female, Male (Count of Participants)
Female	19 82.6%
Male	4 17.4%
Race/Ethnicity, Customized (Count of Participants)
African American	18 78.3%
Non-African American	5 21.7%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	40.4 (8.4)
Education (Count of Participants)
Not high school graduate	3 13%
High school graduate	11 47.8%
At least some college	9 39.1%
Annual household income (Count of Participants)
<$25,000	13 56.5%
$25,000-$50,000	6 26.1%
>$50,000	2 8.7%
Unreported	2 8.7%
Health insurance (Count of Participants)
Private	8 34.8%
Public	14 60.9%
Other	1 4.3%
Atopic status (Count of Participants)
Atopic	20 87%
Not atopic	3 13%
Asthma severity (Count of Participants)
Mild intermittent	6 26.1%
Mild persistent	4 17.4%
Moderate persistent	11 47.8%
Severe persistent	2 8.7%
At least 1 emergency department visit for asthma in last year (Count of Participants)
Yes	7 30.4%
No	16 69.6%
Asthma medication use (participants) [Number]
Albuterol only	13 56.5%
Inhaled corticosteroid	8 34.8%
Leukotriene modifier	3 13%
Oral corticosteroids	1 4.3%
Lung function (percentage) [Mean (Standard Deviation) ]
Pre-bronchodilator FEV1 % predicted	92.7 (26.9)
Pre-bronchodilator FVC % predicted	102.6 (27.7)
Pre-bronchodilator FEV1/FVC	74 (9)
Presence of detectable indoor air nicotine concentration (ug/m^3) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ug/m^3]	0.58 (1.08)
General condition of home (Count of Participants)
1 - Extremely poor: no evidence of cleaning	1 4.3%
2 - Poor: minimal cleaning	2 8.7%
3 - Average: some cleaning	8 34.8%
4 - Above average: clean without much clutter	6 26.1%
5 - Excellent: very clean, organized	2 8.7%

Outcome Measures

1. Primary Outcome

Title	PM2.5 Concentration (ug/m^3)
Description	Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.
Time Frame	Approximately 1 month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	21	22
Mean (Standard Deviation) [ug/m^3]	18.95 (30.09)	32.73 (37.70)

2. Primary Outcome

Title	PM2.5-10 Concentration (ug/m^3)
Description	Coarse particulate matter (PM2.5-10) concentration as assessed by a passive filter placed in the participant's home.
Time Frame	Approximately 1 month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	21	15
Mean (Standard Deviation) [ug/m^3]	7.89 (21.72)	13.93 (9.71)

3. Secondary Outcome

Title	Number of Symptom-free Days
Description	The number of reported days without daytime asthma symptoms (symptom-free days) as based on daily symptom diaries recorded by the patient.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

3 participants did not report their symptoms.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	22	21
Mean (Standard Deviation) [days]	4 (2.55)	3.76 (2.57)

4. Secondary Outcome

Title	Number of Days With Activity Limitations
Description	Number of reported days with activity limitations due to asthma symptoms.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

3 participants did not report their activity limitations.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	22	21
Mean (Standard Deviation) [days]	2.48 (2.68)	2.33 (2.50)

5. Secondary Outcome

Title	Number of Nights Disrupted by Asthma Symptoms
Description	The number of nights spent sleeping that was disrupted due to asthma symptoms.
Time Frame	7 nights

Outcome Measure Data

Analysis Population Description

3 participants did not report the number of nights disrupted due to asthma symptoms.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	22	21
Mean (Standard Deviation) [nights]	0.95 (1.91)	1.14 (1.96)

6. Secondary Outcome

Title	Number of Days of School/Work Missed Due to Asthma Symptoms
Description	The number of days of school or work missed due to asthma symptoms.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

3 participants did not report the number of days of school/work missed due to asthma symptoms.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	22	21
Mean (Standard Deviation) [days]	0.10 (0.44)	0.24 (0.54)

7. Secondary Outcome

Title	Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms
Description	The number of days of unscheduled, urgent visits to the office, urgent care or emergency department due to asthma symptoms.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

3 participants did not report the number of days of unscheduled doctor visits due to asthma symptoms.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	22	21
Mean (Standard Deviation) [days]	0.19 (0.87)	0.14 (0.65)

8. Secondary Outcome

Title	Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI)
Description	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).
Time Frame	Approximately 1 month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	19	18
Mean (Standard Deviation) [units on a scale]	2.44 (2.59)	2.50 (3.43)

9. Secondary Outcome

Title	Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ)
Description	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.
Time Frame	Approximately 1 month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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. High Efficiency Particulate 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. Sham air cleaner
Measure Participants	19	18
Mean (Standard Deviation) [units on a scale]	6.15 (0.84)	6.06 (0.86)

10. Secondary Outcome

Title	Air Nicotine Concentration (ug/m^3)
Description	Indoor air nicotine concentration as assessed by a passive filter placed in the participant's home.
Time Frame	Approximately 1 month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	21	22
Mean (Standard Deviation) [ug/m^3]	0.37 (0.99)	0.37 (0.80)

11. Secondary Outcome

Title	Bronchoalveolar Lavage Differential Neutrophil Count
Description	The percentage of neutrophils in the bronchoalveolar lavage cell count.
Time Frame	1 Day

Outcome Measure Data

Analysis Population Description

2 participants were lost to follow up and 6 participants declined bronchoscopies.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	20	18
Mean (Standard Deviation) [percentage of total cell count]	1.49 (0.83)	2.10 (2.23)

12. Secondary Outcome

Title	Bronchoalveolar Lavage Differential Eosinophil Count
Description	The eosinophil percentage in the bronchoalveolar lavage cell count differential.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

2 participants were lost to follow up and 6 participants declined bronchoscopies.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	20	18
Mean (Standard Deviation) [percentage of total cell count]	0.26 (0.35)	0.45 (0.44)

13. Secondary Outcome

Title	Pre-bronchodilator Forced Vital Capacity (Litres)
Description	Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

14 participants had missing spirometry data.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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. High Efficiency Particulate 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. Sham air cleaner
Measure Participants	16	16
Mean (Standard Deviation) [litres]	3.43 (1.29)	3.52 (1.27)

14. Secondary Outcome

Title	Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)
Description	The pre-bronchodilator forced expiratory volume in 1 second (FEV1) as assessed by spirometry.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

14 participants had missing spirometry data.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (Standard Deviation) [litres]	2.55 (0.92)	2.60 (0.83)

15. Secondary Outcome

Title	FEV1 Percentage of FVC
Description	The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

14 participants had missing spirometry data.

Arm/Group Title	Air Cleaner	Sham Air Cleaner
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (Standard Deviation) [percentage of forced vital capacity]	0.75 (0.07)	0.75 (0.08)

Adverse Events

Time Frame	Approximately 1 year
Arm/Group Title	Air Cleaner		Sham Air Cleaner
Arm/Group Description	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, including in-home health questionnaires, symptom-, diet-, and activity- diaries/recalls, blood, urine and exhaled breath testing, repeated measures of home hand-held lung function, and in-clinic pulmonary function testing with broncho-provocation. Participants will wear a light backpack with air monitoring devices 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 nasal and lower airway sampling will occur under conscious sedation.		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, including in-home health questionnaires, symptom-, diet-, and activity- diaries/recalls, blood, urine and exhaled breath testing, repeated measures of home hand-held lung function, and in-clinic pulmonary function testing with broncho-provocation. Participants will wear a light backpack with air monitoring devices 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 nasal and lower airway sampling will occur under conscious sedation.
All Cause Mortality
	Air Cleaner		Sham Air Cleaner
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Serious Adverse Events
	Air Cleaner		Sham Air Cleaner
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Air Cleaner		Sham Air Cleaner
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.