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Effect of Air Pollution on Long-Term Asthma Severity and Lung Function in Children (FACES)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mickey Leland National Urban Air Toxics Research Center
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00336050
First received: June 9, 2006
Last updated: February 11, 2009
Last verified: February 2009

June 9, 2006
February 11, 2009
November 2000
Not Provided
Effect that air pollution has on the long-term severity of asthma symptoms and lung function in children [ Time Frame: Measured during participants' study visits ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00336050 on ClinicalTrials.gov Archive Site
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Effect of Air Pollution on Long-Term Asthma Severity and Lung Function in Children
Fresno Asthmatic Children's Environment Study

Asthma can be caused by many factors, including mold, pollen, and other airborne pollutants. The purpose of this study is to evaluate the effect that air pollution has on the long-term severity of asthma symptoms and lung function in children.

Asthma prevalence has steadily increased in the United States since the early 1980's; currently more than 20 million people are diagnosed with asthma, including 9 million children. Asthma can be caused by many factors, including pollen, dust, tobacco smoke, and other allergens. Research has shown that even short-term increases in daily levels of air pollution can trigger an increase in asthma symptoms in some individuals. More research is needed to determine how short-term increases in air pollution affect the severity of asthma later in life. The Environmental Protection Agency (EPA) has constructed research monitoring stations, known as Supersites, to advance the understanding of the effect of airborne pollutants on the health of individuals. Data collected from the Supersites provide important information regarding air pollution and air quality levels. This study will use air pollution measurements obtained from the Fresno, California Supersite to monitor participants' exposure to air pollution. The purpose of the study is to determine if children who experience a worsening of asthma symptoms due to an increase in air pollution have greater long-term asthma severity and decreased lung function compared to children who do not experience a worsening of symptoms when exposed to air pollution.

This study will enroll children with asthma who live within 20 kilometers of the EPA Supersite in Fresno, California. Participants will have study visits twice a year for up to 2 ½ years. At study entry, participants will undergo a skin prick allergy test and complete a dietary questionnaire. At each study visit, a respiratory illness questionnaire will be completed, and participants will undergo spirometry tests to measure lung function. In addition to the twice yearly visits, participants will take part in three 14-day sessions each year, during which daily diaries will be completed and spirometry will be performed twice a day. Study staff will gather detailed air pollution information from the Supersite, mobile monitoring trailers, and inside and outside the participants' homes.

Beginning in May 2006, participants will take part in only one study visit and two 14-day sessions each year. Air pollution measurements will be obtained from only the Supersite. To estimate daily exposure to air pollution, all participants will wear a global positioning system (GPS) device and complete daily activity diaries for 5 days during the school year. Fifty participants who have demonstrated compliance with study procedures will be selected to also wear the GPS devices for 5 days during the summer months.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Password-protected database and storage facility that is part of the UCB SPH biorepository

Non-Probability Sample

Convenience sample of children ages 6-11 at intake with proven asthma. All live within a radius of 20 km from the EPA Super Site in Fresno, CA

Asthma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
315
September 2010
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Inclusion Criteria:

  • Asthma, as diagnosed by study criteria, which includes experiencing asthma symptoms and/or use of specific asthma medications in the 12 months prior to study entry
  • Resides within 20 kilometers of the EPA Supersite in Fresno, California
  • Is not planning to move within 3 months of study entry

Exclusion Criteria:

  • Current medical condition that would not allow individual to safely participate in the study
Both
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00336050
1341, R01 HL081521-01A1
No
Ira B. Tager, MD, MPH, School of Public Health, University of California, Berkeley
National Heart, Lung, and Blood Institute (NHLBI)
Mickey Leland National Urban Air Toxics Research Center
Principal Investigator: Ira B. Tager, MD, MPH School of Public Health, UC Berkeley
National Heart, Lung, and Blood Institute (NHLBI)
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP