Trial Outcomes & Findings for School Inner-City Asthma Intervention Study (SICAS-2) (NCT NCT02291302)
NCT ID: NCT02291302
Last Updated: 2025-01-07
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
236 participants
Primary outcome timeframe
up to 12 months
Results posted on
2025-01-07
Participant Flow
Participant milestones
| Measure |
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
|
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
|
Active Air Purifier and Control
Active air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers
|
Sham and Inegrated Pest
Sham air purifiers and active school integrated pest management
integrated pest management: integrated pest management and environmental strategy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
59
|
59
|
|
Overall Study
COMPLETED
|
59
|
59
|
59
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
School Inner-City Asthma Intervention Study (SICAS-2)
Baseline characteristics by cohort
| Measure |
Environmental Intervention
n=59 Participants
Active Classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers
|
Sham and Control (Control)
n=59 Participants
Sham air purifiers and no school integrated pest management environmental intervention
No intervention (control): no integrated pest management and sham air purifier
|
Active Air Purifier and Control
n=59 Participants
Active air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers
|
Sham and Inegrated Pest
n=59 Participants
Sham air purifiers and active school integrated pest management
integrated pest management: integrated pest management and environmental strategy
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age
|
8.2 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
7.9 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
8.3 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
8.2 years
STANDARD_DEVIATION 2.0 • n=4 Participants
|
8.1 years
STANDARD_DEVIATION 2.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
138 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
59 participants
n=7 Participants
|
59 participants
n=5 Participants
|
59 participants
n=4 Participants
|
236 participants
n=21 Participants
|
|
Maximum Number of Days With Asthma Symptoms Within 2 Weeks
|
2.0 days
STANDARD_DEVIATION 3.2 • n=5 Participants
|
3.0 days
STANDARD_DEVIATION 4.7 • n=7 Participants
|
1.5 days
STANDARD_DEVIATION 3.4 • n=5 Participants
|
2.4 days
STANDARD_DEVIATION 4.2 • n=4 Participants
|
2.2 days
STANDARD_DEVIATION 3.9 • n=21 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsMaximum 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
Outcome measures
| Measure |
Environmental Intervention
n=59 Participants
Active Classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers
|
Sham and Control (Control)
n=59 Participants
Sham air purifiers and no school integrated pest management environmental intervention
No intervention (control): no integrated pest management and sham air purifier
|
Active Air Purifier and Control
n=59 Participants
Active air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers
|
Sham and Inegrated Pest
n=59 Participants
Sham air purifiers and active school integrated pest management
integrated pest management: integrated pest management and environmental strategy
|
|---|---|---|---|---|
|
Maximum Number of Days With Asthma Symptoms Within 2 Weeks
|
2.2 days
Standard Deviation 3.5
|
2.7 days
Standard Deviation 4.4
|
1.2 days
Standard Deviation 2
|
2.1 days
Standard Deviation 3.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsSpirometry measure of forced expiration volume in 1 second
Outcome measures
| Measure |
Environmental Intervention
n=55 Participants
Active Classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers
|
Sham and Control (Control)
n=48 Participants
Sham air purifiers and no school integrated pest management environmental intervention
No intervention (control): no integrated pest management and sham air purifier
|
Active Air Purifier and Control
n=57 Participants
Active air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers
|
Sham and Inegrated Pest
n=46 Participants
Sham air purifiers and active school integrated pest management
integrated pest management: integrated pest management and environmental strategy
|
|---|---|---|---|---|
|
Lung Function
|
95.5 percentage of predicted
Standard Deviation 18.5
|
99.2 percentage of predicted
Standard Deviation 16.9
|
97 percentage of predicted
Standard Deviation 14.1
|
94.9 percentage of predicted
Standard Deviation 16.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsNumber of school days missed because of asthma/ 2 weeks
Outcome measures
| Measure |
Environmental Intervention
n=51 Participants
Active Classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers
|
Sham and Control (Control)
n=51 Participants
Sham air purifiers and no school integrated pest management environmental intervention
No intervention (control): no integrated pest management and sham air purifier
|
Active Air Purifier and Control
n=54 Participants
Active air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers
|
Sham and Inegrated Pest
n=46 Participants
Sham air purifiers and active school integrated pest management
integrated pest management: integrated pest management and environmental strategy
|
|---|---|---|---|---|
|
School Absences
|
0.15 days/2 weeks
Standard Deviation 0.61
|
0.18 days/2 weeks
Standard Deviation 0.75
|
0.16 days/2 weeks
Standard Deviation 0.74
|
0.07 days/2 weeks
Standard Deviation 0.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Environmental Intervention
n=51 Participants
Active Classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers
|
Sham and Control (Control)
n=51 Participants
Sham air purifiers and no school integrated pest management environmental intervention
No intervention (control): no integrated pest management and sham air purifier
|
Active Air Purifier and Control
n=54 Participants
Active air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers
|
Sham and Inegrated Pest
n=46 Participants
Sham air purifiers and active school integrated pest management
integrated pest management: integrated pest management and environmental strategy
|
|---|---|---|---|---|
|
Composite Asthma Severity Index
|
2.9 score on a scale
Standard Deviation 2.2
|
2.8 score on a scale
Standard Deviation 2.4
|
3.1 score on a scale
Standard Deviation 2.5
|
2.9 score on a scale
Standard Deviation 2.2
|
POST_HOC outcome
Timeframe: 1 yearClassroom viral exposure will be assessed using two approaches: 1. Airborne respiratory viral exposure (copies/m3) 2. School viral exposure (assessed with virome sequencing)
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: 1 yearThe classroom microbiome will be assessed with deep metagenomics sequencing
Outcome measures
Outcome data not reported
Adverse Events
Environmental Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham and Control (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Air Purifier and Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham and Inegrated Pest
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place