Home Air in Agriculture: Pediatric Intervention Trial

NCT04919915 | Completed

• 5 other identifiers: STUDY000012925R01ES023510-03U01EB021923P30ES007033U2CES026561
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  1 year (study period)

• Asthma Control Test

  ACT score using the ACT questionnaire

  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.

  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)

  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.

  At study enrollment

• Asthma exacerbation

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

  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.

  At study enrollment

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Yakima Valley Farmworkers Clinic

Yakima, Washington, 98902, United States

Location

Related Publications (3)

• 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.

  PMID: 32721578 BACKGROUND

• 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.

  PMID: 32996146 BACKGROUND

• 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.

  PMID: 34980119 DERIVED

Study Officials

• Catherine Karr, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Pediatrics

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 9, 2021
• Study Start: July 14, 2015
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)