Clinical trial NCT04919915: Home Air in Agriculture: Pediatric Intervention Trial
Official title: Home Air in Agriculture: Pediatric Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: Latinx children
agriculture
HEPA air cleaner
home indoor/outdoor sampling
coarse particulate matter
fine particulate matter
endotoxins
antigens
spirometry
exhaled nitric oxide
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: The Yakima Valley Farm Workers Clinic
First posted: 2021-06-09
Enrollment: 71
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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:

1. 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.
2. Conduct a year-long intervention study with longitudinal measurement of key asthmagen exposures and health outcome indicators with minimal participant burden.
3. Develop and characterize evaluation metrics for the process, impact and outcomes of this project in achievement of the aims.
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in particulate matter 2.5 (PM2.5) concentration
timeFrame: 1 year (study period)
measure: Change in ammonia (NH3) concentration
timeFrame: 1 year (study period)
measure: Asthma Control Test
timeFrame: At study enrollment
measure: Clinical utilization
timeFrame: One year (study period)
measure: Inflammatory markers of asthma: Urinary leukotriene
timeFrame: 1 year (study period)
measure: Inflammatory markers of asthma: Fractional exhaled nitric oxide
timeFrame: At study enrollment
measure: Asthma exacerbation
timeFrame: One year (study period)
measure: Lung function
timeFrame: At study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Yakima
country: United States
facility: Yakima Valley Farmworkers Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Catherine Karr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Riederer 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.
citation: Drieling 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.