Grantee Research Project Results
2004 Progress Report: Environmental Tobacco Smoke, Biomarkers, and Childhood Asthma
EPA Grant Number: R830826Title: Environmental Tobacco Smoke, Biomarkers, and Childhood Asthma
Investigators: Klonoff-Cohen, Hillary , Thomas, Ronald G. , Park, Sung Min , Platzker, Arnold , Pickering, Bretten , Woo, Heide , Natarajan, Loki , Jacobs, Robert
Current Investigators: Klonoff-Cohen, Hillary
Institution: University of California - San Diego
EPA Project Officer: Aja, Hayley
Project Period: July 1, 2003 through June 30, 2009 (Extended to June 30, 2010)
Project Period Covered by this Report: July 1, 2003 through June 30, 2004
Project Amount: $750,000
RFA: Biomarkers for the Assessment of Exposure and Toxicity in Children (2002) RFA Text | Recipients Lists
Research Category: Children's Health , Human Health
Objective:
The objectives of this research project are as follows:
Objective #1
The use of biomarkers may have important implications for the detection, prevention, and treatment of environmentally induced diseases in children. This research will identify and evaluate two biomarkers, urine eosinophil protein X (uEPX) and serum eosinophil cationic protein (sECP), which may play a role in predicting childhood asthma.
Hypothesis. ECP and EPX will be useful biomarkers in predicting the presence of disease, clinical severity, and treatment efficacy in children diagnosed with asthma.
Objective #2
Infants exposed to in utero and postnatal environmental tobacco smoke (ETS) will have smaller lungs and reduced airflow, possibly predisposing them to asthma. Childhood asthma results in chronic airway inflammation with mucosal edema and chronic increased airway muscle tone in genetically predisposed children.
Hypothesis. In utero and postnatal ETS exposure (based on infants’ urine cotinine measurements) will result in higher levels of biomarkers (sECP and uEPX). The highest ECP and EPX values will be in asthmatic children exposed to ETS.
Progress Summary:
The start of this research project was delayed because of the time required to receive Institutional Review Board approval from the U.S. Environmental Protection Agency (EPA) and the other institutions. We encountered several difficulties obtaining Human Subjects approval because of the young age of the case and control samples (i.e., birth to 4 months). We finally successfully addressed all concerns and received approval in September 2004 (initially approved in November 2003 but had to be reapproved) (Children’s Hospital Los Angeles), February 2004 (University of California at San Diego), and September 2004 (EPA).
While waiting for Human Subjects approval, effort was devoted to setting up the study. Specifically, we constructed and pilot tested the interview and followup forms, hired and trained the appropriate personnel, pilot tested medical record abstraction forms and asthma diaries, and coordinated laboratory storage and transport. In addition, the database was created. All of these tasks were completed as projected in the study timeline.
As of September 1, 2004, the process of identifying, screening, and enrolling eligible patients was underway and progressing well. The interview process, as well as the collection of urine and blood, is going very smoothly. The major emphasis at this point is twofold: (1) implement a system for the return and followup of patients every 4 months, which involves weekly phone contacts; and (2) improve identification and enrollment of controls. We also hired a Spanish translator to assist the nurse practitioner at the sites (particularly for parents who do not bring Spanish-speaking friends or relatives) to facilitate recruitment. With these additions, recruitment and followup should be optimal.
The laboratory assay for urinary cotinine and the inflammatory markers (urinary EPX and serum ECP) are perfected and will yield valid and reproducible results. Blood and urine collection has been uneventful, although some infants require a fair amount of time to provide urine samples.
We anticipate recruiting a total of 400 patients during the next 3 years, which equates to 133 patients/year (approximately 66 cases and 66 controls for year 1) and 5-6 cases and 5-6 controls/month. Since obtaining final Human Subjects approval from EPA and Children’s Hospital on September 1, 2004, we have recruited 15 cases and 15 controls.
Future Activities:
We will actively recruit eligible patients, obtain informed consent, conduct initial and followup interviews, collect urine for cotinine and EPX analyses, draw blood for sECP testing, abstract medical records, enter and clean the data, and perform preliminary statistical analyses.
Journal Articles:
No journal articles submitted with this report: View all 3 publications for this projectSupplemental Keywords:
asthma, infants, children, inflammatory markers, biomarkers, epidemiology, environmental tobacco smoke, ETS, urine EPX, serum ECP, diagnosis, prevention, environmental management, human health, health, international cooperation, physical aspects, allergens/asthma, biochemistry, children’s health, environmental chemistry, environmental policy, health effects, health risk assessment, physical processes, risk assessment, human health risk assessment, air pollution, airway disease, allergic response, assessment of exposure, asthma indices, asthma triggers, asthmatic children, biomarker, childhood respiratory disease, children’s environmental health, children’s vulnerability, endocrine-disrupting chemicals, exposure, harmful environmental agents, human exposure, human health risk, prenatal exposure, secondhand smoke,Progress and Final Reports:
Original AbstractThe perspectives, information and conclusions conveyed in research project abstracts, progress reports, final reports, journal abstracts and journal publications convey the viewpoints of the principal investigator and may not represent the views and policies of ORD and EPA. Conclusions drawn by the principal investigators have not been reviewed by the Agency.
Project Research Results
- Final
- 2009
- 2008 Progress Report
- 2007 Progress Report
- 2006 Progress Report
- 2005 Progress Report
- Original Abstract
1 journal articles for this project