AsthmaINHALE 2NCT02153359
Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
A study testing High Efficiency Particulate Air Cleaner in people with Asthma, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- High Efficiency Particulate Air Cleaner
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to 11 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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"
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- High Efficiency Particulate Air Cleaner, Sham air cleaner
- Keywords
- asthma, HEPA, air pollutants, lung function, home environment, respiratory symptoms
- Medical subject headings
- Asthma, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Efficiency Particulate Air CleanerDevice
Sham air cleanerDevice
| Study group | Role | What they receive |
|---|---|---|
| Air cleaner then sham air cleaner | Experimental | 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. Receives: Device: High Efficiency Particulate Air Cleaner; Device: Sham air cleaner |
| Sham air cleaner then air cleaner | Sham comparator | 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. Receives: Device: High Efficiency Particulate Air Cleaner; Device: Sham air cleaner |
What is being measured
The primary outcome is the main question the study is designed to answer.
PM2.5 Concentration (ug/m^3)
Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.
Measured: Approximately 1 month
PM2.5-10 Concentration (ug/m^3)
Coarse particulate matter (PM2.5-10) concentration as assessed by a passive filter placed in the participant's home.
Measured: Approximately 1 month
Secondary outcomes (13)
Number of Symptom-free Days
The number of reported days without daytime asthma symptoms (symptom-free days) as based on daily symptom diaries recorded by the patient.
Measured: 7 days
Number of Days With Activity Limitations
Number of reported days with activity limitations due to asthma symptoms.
Measured: 7 days
Number of Nights Disrupted by Asthma Symptoms
The number of nights spent sleeping that was disrupted due to asthma symptoms.
Measured: 7 nights
Number of Days of School/Work Missed Due to Asthma Symptoms
The number of days of school or work missed due to asthma symptoms.
Measured: 7 days
Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms
The number of days of unscheduled, urgent visits to the office, urgent care or emergency department due to asthma symptoms.
Measured: 7 days
Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI)
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).
Measured: Approximately 1 month
Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ)
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.
Measured: Approximately 1 month
Air Nicotine Concentration (ug/m^3)
Indoor air nicotine concentration as assessed by a passive filter placed in the participant's home.
Measured: Approximately 1 month
Bronchoalveolar Lavage Differential Neutrophil Count
The percentage of neutrophils in the bronchoalveolar lavage cell count.
Measured: 1 Day
Bronchoalveolar Lavage Differential Eosinophil Count
The eosinophil percentage in the bronchoalveolar lavage cell count differential.
Measured: 1 day
Pre-bronchodilator Forced Vital Capacity (Litres)
Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry
Measured: 1 day
Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)
The pre-bronchodilator forced expiratory volume in 1 second (FEV1) as assessed by spirometry.
Measured: 1 day
FEV1 Percentage of FVC
The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Sonali Bose, MD MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153359
- Sponsor's protocol ID
- NA_00082646
- Other IDs
- 1K24ES021098-01, K23ES021789
- Acronym
- INHALE 2
- Status last verified
- Aug 2019
- First submitted
- 21 Apr 2014
- Last updated
- 12 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
- ClinicalTrials.gov ID
- NCT02153359
- Acronym / sponsor ID
- INHALE 2 / NA_00082646
- Conditions
- Asthma
- Keywords
- asthma, HEPA, air pollutants, lung function, home environment, respiratory symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Feb 2014 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 12 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air cleaner then sham air cleaner | Experimental | Device: High Efficiency Particulate Air Cleaner, Device: Sham air cleanerA 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 then air cleaner | Sham comparator | Device: High Efficiency Particulate Air Cleaner, Device: Sham air cleanerA 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Efficiency Particulate Air Cleaner | Device | Air cleaner then sham air cleaner, Sham air cleaner then air cleaner |
| Sham air cleaner | Device | Air cleaner then sham air cleaner, Sham air cleaner then air cleaner |
Primary outcome
PM2.5 Concentration (ug/m^3)
Time frame: Approximately 1 month
Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.
PM2.5-10 Concentration (ug/m^3)
Time frame: Approximately 1 month
Coarse particulate matter (PM2.5-10) concentration as assessed by a passive filter placed in the participant's home.
13 secondary outcomes
Number of Symptom-free Days
Time frame: 7 days
Number of Days With Activity Limitations
Time frame: 7 days
Number of Nights Disrupted by Asthma Symptoms
Time frame: 7 nights
Number of Days of School/Work Missed Due to Asthma Symptoms
Time frame: 7 days
Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms
Time frame: 7 days
Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI)
Time frame: Approximately 1 month
Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Approximately 1 month
Air Nicotine Concentration (ug/m^3)
Time frame: Approximately 1 month
Bronchoalveolar Lavage Differential Neutrophil Count
Time frame: 1 Day
Bronchoalveolar Lavage Differential Eosinophil Count
Time frame: 1 day
Pre-bronchodilator Forced Vital Capacity (Litres)
Time frame: 1 day
Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)
Time frame: 1 day
FEV1 Percentage of FVC
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonali Bose, MD MPH principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Efficiency Particulate Air Cleaner in people with Asthma, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PM2.5 Concentration (ug/m^3) (time frame: Approximately 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.