Home Air in Agriculture: Pediatric Intervention Trial

Asthma in Children Clinical Trial

— HAPI  

Official title:

Home Air in Agriculture: Pediatric Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919915
• Other study ID #: STUDY00001292
• Secondary ID: 5R01ES023510-03U
• Status: Completed
• Phase: N/A
• Start date: July 14, 2015
• Est. completion date: February 27, 2019

Study information

• Verified date: June 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 to reduce indoor measures of particulate matter, ammonia, improve clinically relevant measures of asthma health, and reduce biomarkers of inflammation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 27, 2019
• Est. primary completion date: February 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma in Children

Intervention

Device:
• HEPA air cleaner
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.

Locations

Country	Name	City	State
United States	Yakima Valley Farmworkers Clinic	Yakima	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute of Environmental Health Sciences (NIEHS), The Yakima Valley Farm Workers Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 PM(2.5) and NH(3) 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Asthma Control Test	ACT score using the ACT questionnaire	At study enrollment
Primary	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)
Primary	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)
Primary	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
Primary	Asthma exacerbation	Reviewed participant medical records for receipt of prescription for a course of oral corticosteroid.	One year (study period)
Primary	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