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Completed

NCT Number: NCT04919915

Home Air in Agriculture: Pediatric Intervention Trial

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.

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Key information

Conditions

Asthma in Children

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yakima Valley Farmworkers Clinic

Yakima, Washington, 98902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HEPA air cleaner

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Asthma Control Test

    Time frame: At study enrollment

    ACT score using the ACT questionnaire

  4. 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.

  5. 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)

  6. 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.

  7. Asthma exacerbation

    Time frame: One year (study period)

    Reviewed participant medical records for receipt of prescription for a course of oral corticosteroid.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • National Institute of Environmental Health Sciences (NIEHS)
  • The Yakima Valley Farm Workers Clinic

Registry information

Acronym: HAPI

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 9, 2021
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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