Allergens in Inner-City Schools and Childhood Asthma
- Conditions
- Asthma
- Registration Number
- NCT01756391
- Lead Sponsor
- Boston Children's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 351
- Grades K-8 the school year following spring recruitment (Ages 4-15)
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Symptom Days/14 Days 14 days Largest value among the following:
Number of days with wheezing, tightness in the chest, or cough Number of nights with disturbed sleep as a result of asthma Number of days on which the child had to slow down or discontinue play activities because of asthma
- Secondary Outcome Measures
Name Time Method Days of Slowed Activity Due to Asthma 12 months Days of Exercise-induced Symptoms 12 months Days of Cough Without an Upper Respiratory Infection 12 months Nights of Wakening Due to Asthma Symptoms 12 months Number of Hospitalizations 12 months Emergency Department Visits 12 months Unscheduled Physician/Health Care Visits 12 months Prednisone Bursts 12 months FEV1/FVC 12 months FEV1 Percent Predicted 12 months Percent Change in FEV1 After Short-acting Beta Agonist 12 months Exhaled Nitric Oxide Levels 12 months
Trial Locations
- Locations (1)
Children's Hospital, Boston
🇺🇸Boston, Massachusetts, United States