NCT00527345

Brief 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. 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:

  1. 1.Determine whether asthmatic children changing to retrofitted buses with cleaner fuels and engines have a reduction in sub-clinical and clinical asthma severity.
  2. 2.Determine if increased levels of DE exposure lead to an increase in acute clinical and sub-clinical features of asthma in children.
  3. 3.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

4.3 years

First QC Date

September 6, 2007

Last Update Submit

April 13, 2015

Conditions

Keywords

AsthmaDiesel exhaust

Study Arms (3)

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

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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:
  • 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);

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Dept. Environmental and Occupational Health Sciences

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • L.-J. Sally Liu, Sc.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Study Start

March 1, 2005

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations