AsthmaNCT00527345
Children's Exposures/Health Effects/Diesel Exhaust
An observational study of Asthma and Airway Inflammation, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
The contribution of diesel exhaust (DE) to health, especially children's health, is of tremendous public health interest. DE has been associated with worsening asthma and allergies, among other important health effects. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma, Airway Inflammation
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ages 6-11 and attending 1st to 5th grades at schools in one of our target districts; approximately 75% subjects will commute by bus daily, 25% commute by car/walking;
- with or without physician-diagnosed asthma
- If with physician-diagnosed asthma:
- 1 year history, including episodic symptoms of wheezing, cough, and dyspnea;
- mild intermittent (with at least one episode a week requiring inhaler), mild persistent, or moderate persistent severity of asthma by NAEPP Criteria (NHLBI '91);
Who cannot join
- history of smoking by the subject or by a person in the subject's home
- asthma hospitalizations within 4 weeks of the start of each study year
- other chronic diseases such as diabetes, congenital heart disease, chronic renal disease
- new pets in the home
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Dept. Environmental and Occupational Health Sciences
Seattle, Washington, 98195
About this study
Official title: Children's Exposure and Health Effects From Diesel Exhaust Before and After Switch of Schoool Bus Fleets
The contribution of diesel exhaust (DE) to health, especially children's health, is of tremendous public health interest. DE has been associated with worsening asthma and allergies, among other important health effects. Reducing DE exposures has become a major regulatory initiative, and federal, state, and local jurisdictions are investing hundreds of millions of dollars in retrofitting diesel engines in school buses and other changes to reach this goal.
The U.S. Environmental Protection Agency's recent regulations require all on-road diesel vehicles to change to low emission engines and ultra-low-sulfur fuels by 2007 (US EPA '00). In spring 2003, the U.S. EPA announced a nationwide voluntary school bus retrofit initiative. In July 2003, the Washington Legislature enacted a statewide "Diesel Solutions" program that provides 25 million dollars by 2008 to retrofit school diesel buses with cleaner burning engines and fuels, making it one of the largest and most active voluntary school bus retrofit program in the country. If risk assessment estimates are accurate, these changes will have a large public health impact, especially on children who ride school buses daily. However, no studies to-date have rigorously examined school children's exposure to diesel exhaust (DE) and its health effects, nor such a significant change in vehicular pollution control. We propose to seize this opportunity of a large natural experiment taking place in the Puget Sound area and conduct a study to assess health effects from diesel bus exhaust before and after the retrofit of diesel bus fleets between 2005 and 2007. The specific aims of the study are to:
Read more
- Determine whether asthmatic children changing to retrofitted buses with cleaner fuels and engines have a reduction in sub-clinical and clinical asthma severity.
- Determine if increased levels of DE exposure lead to an increase in acute clinical and sub-clinical features of asthma in children.
- Quantify the levels and changes in particle and toxic gas exposures to DE in 3 groups of children commuting to school by retrofitted buses or private cars, old diesel buses to be retrofitted later, and old diesel buses through the study.
Sub-aim 3: Use the time-activity information, personal exposure measurements, and on-bus monitoring data to construct an exposure model to predict individual exposures to DE for all subjects.
Read the detailed description
We will recruit 450 subjects ranging from 9 to 11 years old (or 3rd to 5th graders). These children who commute to school will perform repeated monthly measures of pulmonary function tests using spirometry, pulmonary inflammation via exhaled breath, and asthma symptoms and clinical encounters, up to 3 school years. These 500 children will represent 3 exposure scenarios: 1) one group of 125 children riding retrofitted school buses or private cars; 2) 250 children riding old buses who will change to retrofitted buses during the first or second year of the study; and 3) 125 children who ride old diesel buses through the study. All subjects will be either healthy or having physician-diagnosed asthma with severity ranging from mild intermittent to moderate persistent. Personal exposure monitoring of particulate matter, CO, NO2, and SO2 will be performed on a subset of 144 asthmatic subjects, with each subject being monitored for up to 2 days, in each monitoring year.
Subjects participating in the study will wear a small backpack containing several personal air monitors measuring real-time particulate matter concentrations and carbon monoxide concentrations as well as integrated (24 hour averaged) measurements of SO2 and NO2. The children's personal monitoring will begin when they wake up in the morning and continue for 24-hours. When wearing the backpack is inconvenient, such as when sleeping, the monitoring equipment should be placed in close proximity to the subject. Once the subject arrives at school, s/he will be asked to perform three respiratory tests: exhaled nitric oxide, exhaled breath condensate, and spirometry. At the end of the school day, the subject will be asked to perform the same two tests of lung function as earlier, plus an additional test of exhaled breath condensate. The subject will then continue his/her day as normal. A technician will replace the filter in the particulate matter monitor between 6 and 7 PM. We will repeat the same monitoring procedure the following morning when the subject wakes up for another 24-h. Monitoring will stop on the third morning when the subjects wake up. In addition to the personal monitoring, a monitoring kit will be installed in the subject's school bus and will be operated by a technician. This in-vehicle monitoring kit includes everything contained in the personal monitoring kit, plus a P-TRAK (TSI, model 8525) for real-time ultra-fine particle counts, two Harvard Personal Environmental Monitors (HPEM) with Teflon and quartz filters respectively for determining elemental carbon fractions, an EcoChem PAS2000CE monitor for polycyclic aromatic hydrocarbons (PAHs), and a global positioning system personal acquisition logger (GPS-PAL). The following timeline shows the typical daily schedule for a subject participating in the study.
- Conditions
- Asthma, Airway Inflammation
- Keywords
- Asthma, Diesel exhaust
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | children riding retrofitted school buses or private cars | |
| 2 | children riding old buses who will change to retrofitted buses during the first or second year of the study | |
| 3 | children who ride old diesel buses through the study |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startMar 2005
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- L.-J. Sally Liu, Sc.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527345
- Sponsor's protocol ID
- 12657-CP-001
- Other IDs
- R01ES012657
- Status last verified
- Apr 2015
- First submitted
- 6 Sep 2007
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Exposure and Health Effects From Diesel Exhaust Before and After Switch of Schoool Bus Fleets
- ClinicalTrials.gov ID
- NCT00527345
- Acronym / sponsor ID
- 12657-CP-001
- Conditions
- Asthma, Airway Inflammation
- Keywords
- Asthma, Diesel exhaust
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Mar 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The contribution of diesel exhaust (DE) to health, especially children's health, is of tremendous public health interest. DE has been associated with worsening asthma and allergies, among other important health effects. Reducing DE exposures has become a major regulatory initiative, and federal, state, and local jurisdictions are investing hundreds of millions of dollars in retrofitting diesel engines in school buses and other changes to reach this goal.
The U.S. Environmental Protection Agency's recent regulations require all on-road diesel vehicles to change to low emission engines and ultra-low-sulfur fuels by 2007 (US EPA '00). In spring 2003, the U.S. EPA announced a nationwide voluntary school bus retrofit initiative. In July 2003, the Washington Legislature enacted a statewide "Diesel Solutions" program that provides 25 million dollars by 2008 to retrofit school diesel buses with cleaner burning engines and fuels, making it one of the largest and most active voluntary school bus retrofit program in the country. If risk assessment estimates are accurate, these changes will have a large public health impact, especially on children who ride school buses daily. However, no studies to-date have rigorously examined school children's exposure to diesel exhaust (DE) and its health effects, nor such a significant change in vehicular pollution control. We propose to seize this opportunity of a large natural experiment taking place in the Puget Sound area and conduct a study to assess health effects from diesel bus exhaust before and after the retrofit of diesel bus fleets between 2005 and 2007. The specific aims of the study are to:
- Determine whether asthmatic children changing to retrofitted buses with cleaner fuels and engines have a reduction in sub-clinical and clinical asthma severity.
- Determine if increased levels of DE exposure lead to an increase in acute clinical and sub-clinical features of asthma in children.
- Quantify the levels and changes in particle and toxic gas exposures to DE in 3 groups of children commuting to school by retrofitted buses or private cars, old diesel buses to be retrofitted later, and old diesel buses through the study.
Sub-aim 3: Use the time-activity information, personal exposure measurements, and on-bus monitoring data to construct an exposure model to predict individual exposures to DE for all subjects.
Detailed description
We will recruit 450 subjects ranging from 9 to 11 years old (or 3rd to 5th graders). These children who commute to school will perform repeated monthly measures of pulmonary function tests using spirometry, pulmonary inflammation via exhaled breath, and asthma symptoms and clinical encounters, up to 3 school years. These 500 children will represent 3 exposure scenarios: 1) one group of 125 children riding retrofitted school buses or private cars; 2) 250 children riding old buses who will change to retrofitted buses during the first or second year of the study; and 3) 125 children who ride old diesel buses through the study. All subjects will be either healthy or having physician-diagnosed asthma with severity ranging from mild intermittent to moderate persistent. Personal exposure monitoring of particulate matter, CO, NO2, and SO2 will be performed on a subset of 144 asthmatic subjects, with each subject being monitored for up to 2 days, in each monitoring year.
Subjects participating in the study will wear a small backpack containing several personal air monitors measuring real-time particulate matter concentrations and carbon monoxide concentrations as well as integrated (24 hour averaged) measurements of SO2 and NO2. The children's personal monitoring will begin when they wake up in the morning and continue for 24-hours. When wearing the backpack is inconvenient, such as when sleeping, the monitoring equipment should be placed in close proximity to the subject. Once the subject arrives at school, s/he will be asked to perform three respiratory tests: exhaled nitric oxide, exhaled breath condensate, and spirometry. At the end of the school day, the subject will be asked to perform the same two tests of lung function as earlier, plus an additional test of exhaled breath condensate. The subject will then continue his/her day as normal. A technician will replace the filter in the particulate matter monitor between 6 and 7 PM. We will repeat the same monitoring procedure the following morning when the subject wakes up for another 24-h. Monitoring will stop on the third morning when the subjects wake up. In addition to the personal monitoring, a monitoring kit will be installed in the subject's school bus and will be operated by a technician. This in-vehicle monitoring kit includes everything contained in the personal monitoring kit, plus a P-TRAK (TSI, model 8525) for real-time ultra-fine particle counts, two Harvard Personal Environmental Monitors (HPEM) with Teflon and quartz filters respectively for determining elemental carbon fractions, an EcoChem PAS2000CE monitor for polycyclic aromatic hydrocarbons (PAHs), and a global positioning system personal acquisition logger (GPS-PAL). The following timeline shows the typical daily schedule for a subject participating in the study.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –children riding retrofitted school buses or private cars |
| 2 | – | –children riding old buses who will change to retrofitted buses during the first or second year of the study |
| 3 | – | –children who ride old diesel buses through the study |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ages 6-11 and attending 1st to 5th grades at schools in one of our target districts; approximately 75% subjects will commute by bus daily, 25% commute by car/walking;
- with or without physician-diagnosed asthma
- If with physician-diagnosed asthma:
- 1 year history, including episodic symptoms of wheezing, cough, and dyspnea;
- mild intermittent (with at least one episode a week requiring inhaler), mild persistent, or moderate persistent severity of asthma by NAEPP Criteria (NHLBI '91);
Key exclusion criteria (4 listed)
- history of smoking by the subject or by a person in the subject's home
- asthma hospitalizations within 4 weeks of the start of each study year
- other chronic diseases such as diabetes, congenital heart disease, chronic renal disease
- new pets in the home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L.-J. Sally Liu, Sc.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Airway Inflammation, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.