Effect of Air Pollution on Long-Term Asthma Severity and Lung Function in Children (FACES)
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | June 9, 2006 | ||||
| Last Updated Date | February 11, 2009 | ||||
| Start Date ICMJE | November 2000 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00336050 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Air Pollution on Long-Term Asthma Severity and Lung Function in Children | ||||
| Official Title ICMJE | Fresno Asthmatic Children's Environment Study | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Password-protected database and storage facility that is part of the UCB SPH biorepository |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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 |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 315 | ||||
| Estimated Completion Date | September 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 11 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00336050 | ||||
| Other Study ID Numbers ICMJE | 1341, R01 HL081521-01A1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ira B. Tager, MD, MPH, School of Public Health, University of California, Berkeley | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Mickey Leland National Urban Air Toxics Research Center | ||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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