Asthma in ChildrenHAPINCT04919915
Home Air in Agriculture: Pediatric Intervention Trial
A study testing HEPA air cleaner in people with Asthma in Children, run by University of Washington at 1 site in United States.
Trial summary
This study seeks to reduce exposure to asthmagens in the homes of a community of Latino children residing in an area of intense agricultural production in Eastern Washington by testing the effectiveness of an intervention (high efficiency particulate air filter- HEPA portable room air cleaners) plus asthma education… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- HEPA air cleaner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2015to 27 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Eligibility criteria include male and female, poorly controlled asthma, likely to stay in the area over the course of the study, having only one residence, no smokers in the household and residential proximity to dairy operations/crop production (<400 meters) determined by the telephone screening questionnaire.
Who cannot join
- Prior participation in the Asthma Home Visiting Program, not from the northern third of the lower Yakima Valley, well controlled asthma, unlikely to stay in the are over the course of the study, smokers in the household, no residential proximity to dairy operations or crop production, having more than one residence and inability to communicate over the phone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yakima Valley Farmworkers Clinic
Yakima, Washington, 98902
About this study
This study seeks to reduce exposure to asthmagens in the homes of a community of Latino children residing in an area of intense agricultural production in Eastern Washington by testing the effectiveness of an intervention (high efficiency particulate air filter- HEPA portable room air cleaners) plus asthma education to reduce indoor measures of particulate matter, ammonia, improve clinically relevant measures of asthma health, and reduce biomarkers of inflammation.
Read the detailed description
Over the course of five years, this project's specific aims are as follows:
- Build on a well-established community based participatory research program to engage community partners in the design, implementation and evaluation of this asthma intervention study.
- Conduct a year-long intervention study with longitudinal measurement of key asthmagen exposures and health outcome indicators with minimal participant burden.
- Develop and characterize evaluation metrics for the process, impact and outcomes of this project in achievement of the aims.
- Promote sustainable public health action via positive and transparent communications about the project to participants, local stakeholders, and state level policy makers through broad-based community outreach.
- Conditions
- Asthma in Children
- Being tested
- HEPA air cleaner
- Keywords
- Latinx children, agriculture, HEPA air cleaner, home indoor/outdoor sampling, coarse particulate matter, fine particulate matter, endotoxins, antigens, spirometry, exhaled nitric oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPA air cleanerDevice
Participants in the intervention group received two HEPA air cleaners per household. They were informed to place the HEPA air cleaners in the child's bedroom and the living room. Field staff provided and discuss how to use the air cleaner which promoted continuous operation of both air cleaners, keeping the child's bedroom door closed, and selected the highest fan speed. Typical use of the HEPA cleaners were questioned during the mid-study and final visits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Households are randomly assigned to the intervention group with asthma education and received two HEPA air cleaners designed to reduce PM and NH3. Receives: Device: HEPA air cleaner |
| Control group | No intervention | Households are randomly assigned to the control group. They only received the asthma education during the study period. These households receive a HEPA air cleaner at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in particulate matter 2.5 (PM2.5) concentration
Indoor air sampling for PM2.5 collected over a 14-day period. MicroPEM (RTI International, Research Triangle Park, NC, USA) is turn on and left on for 14 days. Measurements collected at beginning and at 1 year after enrollment.
Measured: 1 year (study period)
Change in ammonia (NH3) concentration
Indoor air sampling for NH3 collected over a 14-day period. Ogawa passive sampler (Ogawa USA, Pompano Beach, Fl, USA) is left open for 14 days. Measurements collected at beginning and at 1 year after enrollment.
Measured: 1 year (study period)
Asthma Control Test
ACT score using the ACT questionnaire
Measured: At study enrollment
Clinical utilization
Caregivers were asked if child had a scheduled or unscheduled ("urgent") clinical visit with a doctor or health care provider, emergency department, or overnight hospitalization for asthma symptoms. Number and types of visits are reported.
Measured: One year (study period)
Inflammatory markers of asthma: Urinary leukotriene
Measured urinary leukotriene concentration and specific gravity in child urine sample. Measurements collected at enrollment, mid-study (4-6 months after enrollment), and end of study (1 year after enrollment)
Measured: 1 year (study period)
Inflammatory markers of asthma: Fractional exhaled nitric oxide
Portable NIOX VERO (Aerocrine Inc, Stockholm, Sweden) for direct measurement of fractional exhaled nitric oxide.
Measured: At study enrollment
Asthma exacerbation
Reviewed participant medical records for receipt of prescription for a course of oral corticosteroid.
Measured: One year (study period)
Lung function
Measured lung fuction using EasyOne spirometer (NDD Technologies, Andover, MA). Minimum of three exhalations with acceptable starts, complete exhalation, and no coughs until two exhalations with acceptable repeatability was achieved.
Measured: At study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start14 Jul 2015
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), National Institute for Biomedical Imaging and Bioengineering (NIBIB), The Yakima Valley Farm Workers Clinic
- Responsible party
- Principal investigator, Catherine Karr, University of Washington
- Investigators
- Catherine Karr, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919915
- Sponsor's protocol ID
- STUDY00001292
- Other IDs
- 5R01ES023510-03, U01EB021923, P30ES007033, U2CES026561
- Acronym
- HAPI
- Status last verified
- Jun 2021
- First submitted
- 19 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data has been shared with the NIH Chear Lab as part of U2CES02651
Publications
Masterson EE, Younglove LB, Perez A, Torres E, Krenz JE, Tchong French MI, Riederer AM, Sampson PD, Metwali N, Min E, Jansen KL, Aisenberg G, Babadi RS, Farquhar SA, Thorne PS, Karr CJ. The home air in agriculture pediatric intervention (HAPI) trial: Rationale and methods. Contemp Clin Trials. 2020 Sep;96:106085. doi: 10.1016/j.cct.2020.106085. Epub 2020 Jul 25.
PubMed 32721578Riederer AM, Krenz JE, Tchong-French MI, Torres E, Perez A, Younglove LR, Jansen KL, Hardie DC, Farquhar SA, Sampson PD, Karr CJ. Effectiveness of portable HEPA air cleaners on reducing indoor PM2.5 and NH3 in an agricultural cohort of children with asthma: A randomized intervention trial. Indoor Air. 2021 Mar;31(2):454-466. doi: 10.1111/ina.12753. Epub 2021 Jan 22.
PubMed 32996146Drieling RL, Sampson PD, Krenz JE, Tchong French MI, Jansen KL, Massey AE, Farquhar SA, Min E, Perez A, Riederer AM, Torres E, Younglove LR, Aisenberg E, Andra SS, Kim-Schulze S, Karr CJ. Randomized trial of a portable HEPA air cleaner intervention to reduce asthma morbidity among Latino children in an agricultural community. Environ Health. 2022 Jan 3;21(1):1. doi: 10.1186/s12940-021-00816-w.
PubMed 34980119
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Air in Agriculture: Pediatric Intervention Trial
- ClinicalTrials.gov ID
- NCT04919915
- Acronym / sponsor ID
- HAPI / STUDY00001292
- Conditions
- Asthma in Children
- Keywords
- Latinx children, agriculture, HEPA air cleaner, home indoor/outdoor sampling, coarse particulate matter, fine particulate matter, endotoxins, antigens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), National Institute for Biomedical Imaging and Bioengineering (NIBIB), The Yakima Valley Farm Workers Clinic
- Study start
- 14 Jul 2015 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to reduce exposure to asthmagens in the homes of a community of Latino children residing in an area of intense agricultural production in Eastern Washington by testing the effectiveness of an intervention (high efficiency particulate air filter- HEPA portable room air cleaners) plus asthma education to reduce indoor measures of particulate matter, ammonia, improve clinically relevant measures of asthma health, and reduce biomarkers of inflammation.
Detailed description
Over the course of five years, this project's specific aims are as follows:
- Build on a well-established community based participatory research program to engage community partners in the design, implementation and evaluation of this asthma intervention study.
- Conduct a year-long intervention study with longitudinal measurement of key asthmagen exposures and health outcome indicators with minimal participant burden.
- Develop and characterize evaluation metrics for the process, impact and outcomes of this project in achievement of the aims.
- Promote sustainable public health action via positive and transparent communications about the project to participants, local stakeholders, and state level policy makers through broad-based community outreach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Device: HEPA air cleanerHouseholds are randomly assigned to the intervention group with asthma education and received two HEPA air cleaners designed to reduce PM and NH3. |
| Control group | No intervention | –Households are randomly assigned to the control group. They only received the asthma education during the study period. These households receive a HEPA air cleaner at the end of the study. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Eligibility criteria include male and female, poorly controlled asthma, likely to stay in the area over the course of the study, having only one residence, no smokers in the household and residential proximity to dairy operations/crop production (<400 meters) determined by the telephone screening questionnaire.
Key exclusion criteria (1 listed)
- Prior participation in the Asthma Home Visiting Program, not from the northern third of the lower Yakima Valley, well controlled asthma, unlikely to stay in the are over the course of the study, smokers in the household, no residential proximity to dairy operations or crop production, having more than one residence and inability to communicate over the phone.
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 |
|---|---|---|
| HEPA air cleanerParticipants in the intervention group received two HEPA air cleaners per household. They were informed to place the HEPA air cleaners in the child's bedroom and the living room. Field staff provided and discuss how to use the air cleaner which promoted continuous operation of both air cleaners, keeping the child's bedroom door closed, and selected the highest fan speed. Typical use of the HEPA cleaners were questioned during the mid-study and final visits. | Device | Intervention group |
Primary outcome
Change in particulate matter 2.5 (PM2.5) concentration
Time frame: 1 year (study period)
Indoor air sampling for PM2.5 collected over a 14-day period. MicroPEM (RTI International, Research Triangle Park, NC, USA) is turn on and left on for 14 days. Measurements collected at beginning and at 1 year after enrollment.
Change in ammonia (NH3) concentration
Time frame: 1 year (study period)
Indoor air sampling for NH3 collected over a 14-day period. Ogawa passive sampler (Ogawa USA, Pompano Beach, Fl, USA) is left open for 14 days. Measurements collected at beginning and at 1 year after enrollment.
Asthma Control Test
Time frame: At study enrollment
ACT score using the ACT questionnaire
Clinical utilization
Time frame: One year (study period)
Caregivers were asked if child had a scheduled or unscheduled ("urgent") clinical visit with a doctor or health care provider, emergency department, or overnight hospitalization for asthma symptoms. Number and types of visits are reported.
Inflammatory markers of asthma: Urinary leukotriene
Time frame: 1 year (study period)
Measured urinary leukotriene concentration and specific gravity in child urine sample. Measurements collected at enrollment, mid-study (4-6 months after enrollment), and end of study (1 year after enrollment)
Inflammatory markers of asthma: Fractional exhaled nitric oxide
Time frame: At study enrollment
Portable NIOX VERO (Aerocrine Inc, Stockholm, Sweden) for direct measurement of fractional exhaled nitric oxide.
Asthma exacerbation
Time frame: One year (study period)
Reviewed participant medical records for receipt of prescription for a course of oral corticosteroid.
Lung function
Time frame: At study enrollment
Measured lung fuction using EasyOne spirometer (NDD Technologies, Andover, MA). Minimum of three exhalations with acceptable starts, complete exhalation, and no coughs until two exhalations with acceptable repeatability was achieved.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Background: PubMed 32721578Masterson EE, Younglove LB, Perez A, Torres E, Krenz JE, Tchong French MI, Riederer AM, Sampson PD, Metwali N, Min E, Jansen KL, Aisenberg G, Babadi RS, Farquhar SA, Thorne PS, Karr CJ. The home air in agriculture pediatric intervention (HAPI) trial: Rationale and methods. Contemp Clin Trials. 2020 Sep;96:106085. doi: 10.1016/j.cct.2020.106085. Epub 2020 Jul 25.
- Background: PubMed 32996146Riederer AM, Krenz JE, Tchong-French MI, Torres E, Perez A, Younglove LR, Jansen KL, Hardie DC, Farquhar SA, Sampson PD, Karr CJ. Effectiveness of portable HEPA air cleaners on reducing indoor PM2.5 and NH3 in an agricultural cohort of children with asthma: A randomized intervention trial. Indoor Air. 2021 Mar;31(2):454-466. doi: 10.1111/ina.12753. Epub 2021 Jan 22.
- Derived from this study: PubMed 34980119Drieling RL, Sampson PD, Krenz JE, Tchong French MI, Jansen KL, Massey AE, Farquhar SA, Min E, Perez A, Riederer AM, Torres E, Younglove LR, Aisenberg E, Andra SS, Kim-Schulze S, Karr CJ. Randomized trial of a portable HEPA air cleaner intervention to reduce asthma morbidity among Latino children in an agricultural community. Environ Health. 2022 Jan 3;21(1):1. doi: 10.1186/s12940-021-00816-w.
- Individual participant dataSharing planned: Yes. Data has been shared with the NIH Chear Lab as part of U2CES02651
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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.
Catherine Karr, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEPA air cleaner in people with Asthma in Children, run by University of Washington at 1 site 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 1 inclusion and 1 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 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in particulate matter 2.5 (PM2.5) concentration (time frame: 1 year (study period)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04919915, which also lists 3 linked publications.
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 9 Jun 2021.