Asthma
Conditions
Brief summary
The investigators aim to pilot the role of school based intervention consisting of enhanced integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.
Detailed description
By piloting this school based intervention, the investigators hope to learn from this study the best way to design and implement more cost and time efficient large-based school-based environmental interventions that may potentially help a community of children with asthma, allergic diseases, and its associated morbidity.
Interventions
integrated pest management and environmental strategy
OTHERair purifier
air purifiers
OTHERSham air purifier
sham air purifiers
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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 |
|---|---|---|
| Asthma Symptoms | over a two week period at Baseline and Months 3, 6, 9 and 12 | number of days of wheezing/cough |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung Function | measured at baseline and months 6 and 12 | peak expiratory flow (PEF) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Air Purifier + IPM classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers | 4 |
| Sham and no IPM sham air purifiers and no school integrated pest management environmental intervention | 7 |
| Air Purifier and no IPM air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers | 9 |
| Sham and IPM classroom sham air purifiers and school integrated pest management
integrated pest management: integrated pest management and environmental strategy | 5 |
| Total | 25 |
Baseline characteristics
| Characteristic | Air Purifier + IPM | Sham and no IPM | Air Purifier and no IPM | Sham and IPM | Total |
|---|---|---|---|---|---|
| Age, Continuous | 8.6 years | 10.0 years | 9.2 years | 9.4 years | 9.4 years |
| Forced Vital Capacity (FVC) | 1.4 Liters | 1.6 Liters | 1.6 Liters | 1.8 Liters | 1.6 Liters |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants | 3 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 10 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 7 | 0 / 9 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 | 0 / 9 | 0 / 5 |
Outcome results
Primary
Asthma Symptoms
number of days of wheezing/cough
Time frame: over a two week period at Baseline and Months 3, 6, 9 and 12
Population: The number of participants analyzed here excludes participants for whom follow-up for health outcomes was incomplete.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Air Purifier + IPM | Asthma Symptoms | month 6 | 5 Days |
| Air Purifier + IPM | Asthma Symptoms | baseline | 1.5 Days |
| Air Purifier + IPM | Asthma Symptoms | month 9 | 3.5 Days |
| Air Purifier + IPM | Asthma Symptoms | month 3 | 5.5 Days |
| Air Purifier + IPM | Asthma Symptoms | month 12 | 14 Days |
| Sham and no IPM | Asthma Symptoms | month 6 | 3.25 Days |
| Sham and no IPM | Asthma Symptoms | month 3 | 7.3 Days |
| Sham and no IPM | Asthma Symptoms | month 9 | 8.25 Days |
| Sham and no IPM | Asthma Symptoms | baseline | 2.9 Days |
| Sham and no IPM | Asthma Symptoms | month 12 | 1 Days |
| Air Purifier and no IPM | Asthma Symptoms | month 12 | 1.3 Days |
| Air Purifier and no IPM | Asthma Symptoms | baseline | 1 Days |
| Air Purifier and no IPM | Asthma Symptoms | month 3 | 1.3 Days |
| Air Purifier and no IPM | Asthma Symptoms | month 6 | 2 Days |
| Air Purifier and no IPM | Asthma Symptoms | month 9 | 2.5 Days |
| Sham and IPM | Asthma Symptoms | month 12 | 0 Days |
| Sham and IPM | Asthma Symptoms | month 9 | 1.5 Days |
| Sham and IPM | Asthma Symptoms | month 3 | 2.7 Days |
| Sham and IPM | Asthma Symptoms | baseline | 0.4 Days |
| Sham and IPM | Asthma Symptoms | month 6 | 0.5 Days |
Secondary
Lung Function
peak expiratory flow (PEF)
Time frame: measured at baseline and months 6 and 12
Population: The number of participants analyzed here excludes participants for whom follow-up for health outcomes was incomplete.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Air Purifier + IPM | Lung Function | Baseline | 3.1 Liters/second | Standard Error 0.3 |
| Air Purifier + IPM | Lung Function | month 12 | 3.1 Liters/second | Standard Error 0.5 |
| Air Purifier + IPM | Lung Function | month 6 | 3.1 Liters/second | Standard Error 0.3 |
| Sham and no IPM | Lung Function | Baseline | 2.9 Liters/second | Standard Error 0.3 |
| Sham and no IPM | Lung Function | month 12 | 3.3 Liters/second | Standard Error 0.5 |
| Sham and no IPM | Lung Function | month 6 | 3.3 Liters/second | Standard Error 0.5 |
| Air Purifier and no IPM | Lung Function | month 6 | 2.9 Liters/second | Standard Error 0.3 |
| Air Purifier and no IPM | Lung Function | Baseline | 2.7 Liters/second | Standard Error 0.4 |
| Air Purifier and no IPM | Lung Function | month 12 | 3.3 Liters/second | Standard Error 0.3 |
| Sham and IPM | Lung Function | Baseline | 3.6 Liters/second | Standard Error 0.3 |
| Sham and IPM | Lung Function | month 12 | 4.0 Liters/second | Standard Error 0.7 |
| Sham and IPM | Lung Function | month 6 | 3.7 Liters/second | Standard Error 0.3 |