Asthma
Conditions
Keywords
pediatric, childhood, allergy
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.
Interventions
None listed
Sponsors
National Institutes of Health (NIH)
Boston Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Days of Slowed Activity Due to Asthma | 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 |
| Unscheduled Physician/Health Care Visits | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observational Cohort students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained | 351 |
| Total | 351 |
Baseline characteristics
| Characteristic | Observational Cohort |
|---|---|
| Age, Continuous | 7.9 years |
| Region of Enrollment United States | 351 participants |
| Sex: Female, Male Female | 169 Participants |
| Sex: Female, Male Male | 182 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 351 |
| serious Total, serious adverse events | 0 / 351 |
Outcome results
Primary
Maximum Symptom 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
Time frame: 14 days
Population: Those with appropriate follow up and school/home allergen exposure data and allergy sensitization data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational Cohort | Maximum Symptom Days/14 Days | 2.7 days | Standard Deviation 4 |
Secondary
Days of Cough Without an Upper Respiratory Infection
Time frame: 12 months
Secondary
Days of Exercise-induced Symptoms
Time frame: 12 months
Secondary
Days of Slowed Activity Due to Asthma
Time frame: 12 months
Secondary
Emergency Department Visits
Time frame: 12 months
Secondary
Emergency Department Visits
Time frame: 12 months
Secondary
Exhaled Nitric Oxide Levels
Time frame: 12 months
Secondary
FEV1/FVC
Time frame: 12 months
Secondary
FEV1 Percent Predicted
Time frame: 12 months
Secondary
Nights of Wakening Due to Asthma Symptoms
Time frame: 12 months
Secondary
Number of Hospitalizations
Time frame: 12 months
Secondary
Percent Change in FEV1 After Short-acting Beta Agonist
Time frame: 12 months
Secondary
Prednisone Bursts
Time frame: 12 months
Secondary
Unscheduled Physician/Health Care Visits
Time frame: 12 months