This trial is active, not recruiting.

Condition asthma
Sponsor Children's Hospital Boston
Collaborator National Institutes of Health (NIH)
Start date March 2008
End date October 2018
Trial size 400 participants
Trial identifier NCT01756391, R01 AI 0739654


Asthma is a disease that affects more than 12% of Americans under the age of 18 for over 14 million missed school days per year, and is the number one cause of school absences in America. Elementary school children spend 6 to 10 hours a day in school, and most of that time is spent in one classroom. The goals of this project are to provide an understanding of exposure risk factors specific to the classroom. This is critical, because the classroom environment could potentially be considered as an effective target for prevention of inner-city asthma morbidity by reducing exposures to many symptomatic children through an intervention in the school classrooms.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

maximum days of symptoms/ 2 weeks
time frame: 12 months

Secondary Outcomes

days of slowed activity due to asthma
time frame: 12 months
days of exercise-induced symptoms
time frame: 12 months
days of cough without an upper respiratory infection
time frame: 12 months
nights of wakening due to asthma symptoms
time frame: 12 months
number of hospitalizations
time frame: 12 months
emergency department visits
time frame: 12 months
unscheduled physician/health care visits
time frame: 12 months
prednisone bursts
time frame: 12 months
time frame: 12 months
FEV1 percent predicted
time frame: 12 months
percent change in FEV1 after short-acting beta agonist
time frame: 12 months
exhaled nitric oxide levels
time frame: 12 months

Eligibility Criteria

Male or female participants from 4 years up to 15 years old.

Inclusion Criteria: - Grades K-8 the school year following spring recruitment (Ages 5-15) - Attend one of the schools in the fall where permission obtained for classroom sampling. - Able to provide assent and parent/guardian able to provide informed consent Physician-Diagnosed asthma AND Wheezing in the previous 12 months Exclusion Criteria: - Significant pulmonary diseases other than asthma that might influence test results or pose risks (e.g., cystic fibrosis, sarcoidosis, bronchiectasis) - Cardiovascular disease that requires daily medication - Taking a beta blocker - Active smoker - Unable to follow through with study visit or complete study procedures

Additional Information

Official title Allergens in Inner-City Schools and Childhood Asthma
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Children's Hospital Boston.