Asthma
Conditions
Brief summary
The investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren.
Detailed description
Our proposal builds upon our established, successful school-based infrastructure to determine whether a school/classroom intervention will efficiently and effectively improve asthma morbidity by reducing these exposures. Our goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren. Our central hypothesis is that reducing classroom/school exposure to mouse allergen, mold, and particulate pollutants will decrease asthma morbidity in students with asthma. The investigators plan to test this hypothesis in an intervention study of 300 elementary students with asthma from multiple classrooms in inner-city elementary schools. Our clinical trial aims are to determine the effectiveness of a school/classroom based environmental intervention (school integrated pest management and classroom air purifying filter units within these schools) to reduce asthma morbidity. Our mechanistic aim is to test the hypothesis that effects of school/classroom-based environmental interventions on symptoms/other measures of asthma control occur through changes in gene methylation or expression in pathways (and secondarily, in genes) relevant to airway function and asthma. This will expand our understanding of asthma immunopathogenesis and create opportunities to identify potential novel targets for asthma therapy.
Interventions
integrated pest management and environmental strategy
OTHERair purifier
air purifiers
no integrated pest management and sham air purifier
Sponsors
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard School of Public Health (HSPH)
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* grades K-8 with asthma attending sampling/intervention schools
Exclusion criteria
* moving schools
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Number of Days With Asthma Symptoms Within 2 Weeks | up to 12 months | Maximum number of 1. Days with wheezing, tightness in the chest, or cough and/or 2. Nights with disturbed sleep as a result of asthma and/or 3. Days on which the child had to slow down or discontinue play activities because of asthma This is defined as a cumulative assessment from the different variables listed in the Measure Description |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lung Function | 12 months | Spirometry measure of forced expiration volume in 1 second |
| School Absences | 12 months | Number of school days missed because of asthma/ 2 weeks |
| Composite Asthma Severity Index | 12 months | \[a comprehensive severity scale of day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations\], health care utilization, and pulmonary function testing (PFT's) including FEV1; FEV1/FVC, FEF25-75. CASI ranges from 0 (lowest) -20 points (highest) with a minimal clinically important difference of 0.49 points. The higher score is worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Environmental Intervention Active Classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers | 59 |
| Sham and Control (Control) Sham air purifiers and no school integrated pest management environmental intervention
No intervention (control): no integrated pest management and sham air purifier | 59 |
| Active Air Purifier and Control Active air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers | 59 |
| Sham and Inegrated Pest Sham air purifiers and active school integrated pest management
integrated pest management: integrated pest management and environmental strategy | 59 |
| Total | 236 |
Baseline characteristics
| Characteristic | Active Air Purifier and Control | Total | Sham and Inegrated Pest | Environmental Intervention | Sham and Control (Control) |
|---|---|---|---|---|---|
| Age, Customized Age | 8.3 years STANDARD_DEVIATION 2.2 | 8.1 years STANDARD_DEVIATION 2 | 8.2 years STANDARD_DEVIATION 2 | 8.2 years STANDARD_DEVIATION 1.9 | 7.9 years STANDARD_DEVIATION 1.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 138 Participants | 33 Participants | 38 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 93 Participants | 26 Participants | 21 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 0 Participants | 0 Participants | 3 Participants |
| Maximum Number of Days With Asthma Symptoms Within 2 Weeks | 1.5 days STANDARD_DEVIATION 3.4 | 2.2 days STANDARD_DEVIATION 3.9 | 2.4 days STANDARD_DEVIATION 4.2 | 2.0 days STANDARD_DEVIATION 3.2 | 3.0 days STANDARD_DEVIATION 4.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 6 Participants | 2 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 57 Participants | 13 Participants | 17 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 17 Participants | 6 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 55 Participants | 12 Participants | 17 Participants | 11 Participants |
| Race (NIH/OMB) White | 20 Participants | 100 Participants | 26 Participants | 21 Participants | 33 Participants |
| Region of Enrollment United States | 59 participants | 236 participants | 59 participants | 59 participants | 59 participants |
| Sex: Female, Male Female | 32 Participants | 113 Participants | 33 Participants | 26 Participants | 22 Participants |
| Sex: Female, Male Male | 27 Participants | 123 Participants | 26 Participants | 33 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 59 | 0 / 59 | 0 / 59 |
| other Total, other adverse events | 0 / 59 | 0 / 59 | 0 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 | 0 / 59 | 0 / 59 |
Outcome results
Primary
Maximum Number of Days With Asthma Symptoms Within 2 Weeks
Maximum number of 1. Days with wheezing, tightness in the chest, or cough and/or 2. Nights with disturbed sleep as a result of asthma and/or 3. Days on which the child had to slow down or discontinue play activities because of asthma This is defined as a cumulative assessment from the different variables listed in the Measure Description
Time frame: up to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Environmental Intervention | Maximum Number of Days With Asthma Symptoms Within 2 Weeks | 2.2 days | Standard Deviation 3.5 |
| Sham and Control (Control) | Maximum Number of Days With Asthma Symptoms Within 2 Weeks | 2.7 days | Standard Deviation 4.4 |
| Active Air Purifier and Control | Maximum Number of Days With Asthma Symptoms Within 2 Weeks | 1.2 days | Standard Deviation 2 |
| Sham and Inegrated Pest | Maximum Number of Days With Asthma Symptoms Within 2 Weeks | 2.1 days | Standard Deviation 3.6 |
Post Hoc
Classroom Microbiome
The classroom microbiome will be assessed with deep metagenomics sequencing
Time frame: 1 year
Post Hoc
Classroom Viral Exposure
Classroom viral exposure will be assessed using two approaches: 1. Airborne respiratory viral exposure (copies/m3) 2. School viral exposure (assessed with virome sequencing)
Time frame: 1 year
Other Pre-specified
Composite Asthma Severity Index
\[a comprehensive severity scale of day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations\], health care utilization, and pulmonary function testing (PFT's) including FEV1; FEV1/FVC, FEF25-75. CASI ranges from 0 (lowest) -20 points (highest) with a minimal clinically important difference of 0.49 points. The higher score is worse outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Environmental Intervention | Composite Asthma Severity Index | 2.9 score on a scale | Standard Deviation 2.2 |
| Sham and Control (Control) | Composite Asthma Severity Index | 2.8 score on a scale | Standard Deviation 2.4 |
| Active Air Purifier and Control | Composite Asthma Severity Index | 3.1 score on a scale | Standard Deviation 2.5 |
| Sham and Inegrated Pest | Composite Asthma Severity Index | 2.9 score on a scale | Standard Deviation 2.2 |
Other Pre-specified
Lung Function
Spirometry measure of forced expiration volume in 1 second
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Environmental Intervention | Lung Function | 95.5 percentage of predicted | Standard Deviation 18.5 |
| Sham and Control (Control) | Lung Function | 99.2 percentage of predicted | Standard Deviation 16.9 |
| Active Air Purifier and Control | Lung Function | 97 percentage of predicted | Standard Deviation 14.1 |
| Sham and Inegrated Pest | Lung Function | 94.9 percentage of predicted | Standard Deviation 16.1 |
Other Pre-specified
School Absences
Number of school days missed because of asthma/ 2 weeks
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Environmental Intervention | School Absences | 0.15 days/2 weeks | Standard Deviation 0.61 |
| Sham and Control (Control) | School Absences | 0.18 days/2 weeks | Standard Deviation 0.75 |
| Active Air Purifier and Control | School Absences | 0.16 days/2 weeks | Standard Deviation 0.74 |
| Sham and Inegrated Pest | School Absences | 0.07 days/2 weeks | Standard Deviation 0.33 |