Trial Outcomes & Findings for Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma (NCT NCT01913795)
NCT ID: NCT01913795
Last Updated: 2022-06-07
Results Overview
number of days of wheezing/cough
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
over a two week period at Baseline and Months 3, 6, 9 and 12
Results posted on
2022-06-07
Participant Flow
Participant milestones
| Measure |
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
|
Sham and no IPM
sham air purifiers and no school integrated pest management environmental intervention
|
Air Purifier and no IPM
air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers
|
Sham and IPM
classroom sham air purifiers and school integrated pest management
integrated pest management: integrated pest management and environmental strategy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
10
|
9
|
6
|
|
Overall Study
COMPLETED
|
4
|
7
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma
Baseline characteristics by cohort
| Measure |
Air Purifier + IPM
n=4 Participants
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 no IPM
n=7 Participants
sham air purifiers and no school integrated pest management environmental intervention
|
Air Purifier and no IPM
n=9 Participants
air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers
|
Sham and IPM
n=5 Participants
classroom sham air purifiers and school integrated pest management
integrated pest management: integrated pest management and environmental strategy
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.6 years
n=5 Participants
|
10.0 years
n=7 Participants
|
9.2 years
n=5 Participants
|
9.4 years
n=4 Participants
|
9.4 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Forced Vital Capacity (FVC)
|
1.4 Liters
n=5 Participants
|
1.6 Liters
n=7 Participants
|
1.6 Liters
n=5 Participants
|
1.8 Liters
n=4 Participants
|
1.6 Liters
n=21 Participants
|
PRIMARY outcome
Timeframe: over a two week period at Baseline and Months 3, 6, 9 and 12Population: The number of participants analyzed here excludes participants for whom follow-up for health outcomes was incomplete.
number of days of wheezing/cough
Outcome measures
| Measure |
Air Purifier + IPM
n=4 Participants
4 subjects
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 no IPM
n=7 Participants
7 subjects
sham air purifiers and no school integrated pest management environmental intervention
|
Air Purifier and no IPM
n=9 Participants
9 subjects
air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers
|
Sham and IPM
n=5 Participants
5 subjects
classroom sham air purifiers and school integrated pest management
integrated pest management: integrated pest management and environmental strategy
|
|---|---|---|---|---|
|
Asthma Symptoms
month 9
|
3.5 Days
Interval 3.0 to 4.0
|
8.25 Days
Interval 2.0 to 14.0
|
2.5 Days
Interval 0.0 to 5.0
|
1.5 Days
Interval 0.0 to 3.0
|
|
Asthma Symptoms
month 12
|
14 Days
Interval 14.0 to 14.0
|
1 Days
Interval 1.0 to 1.0
|
1.3 Days
Interval 0.0 to 2.0
|
0 Days
Interval 0.0 to 0.0
|
|
Asthma Symptoms
baseline
|
1.5 Days
Interval 0.0 to 3.0
|
2.9 Days
Interval 0.0 to 14.0
|
1 Days
Interval 0.0 to 3.0
|
0.4 Days
Interval 0.0 to 2.0
|
|
Asthma Symptoms
month 3
|
5.5 Days
Interval 2.0 to 9.0
|
7.3 Days
Interval 0.0 to 14.0
|
1.3 Days
Interval 0.0 to 2.0
|
2.7 Days
Interval 2.0 to 4.0
|
|
Asthma Symptoms
month 6
|
5 Days
Interval 5.0 to 5.0
|
3.25 Days
Interval 0.0 to 5.0
|
2 Days
Interval 2.0 to 2.0
|
0.5 Days
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: measured at baseline and months 6 and 12Population: The number of participants analyzed here excludes participants for whom follow-up for health outcomes was incomplete.
peak expiratory flow (PEF)
Outcome measures
| Measure |
Air Purifier + IPM
n=4 Participants
4 subjects
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 no IPM
n=7 Participants
7 subjects
sham air purifiers and no school integrated pest management environmental intervention
|
Air Purifier and no IPM
n=9 Participants
9 subjects
air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers
|
Sham and IPM
n=5 Participants
5 subjects
classroom sham air purifiers and school integrated pest management
integrated pest management: integrated pest management and environmental strategy
|
|---|---|---|---|---|
|
Lung Function
Baseline
|
3.1 Liters/second
Standard Error 0.3
|
2.9 Liters/second
Standard Error 0.3
|
2.7 Liters/second
Standard Error 0.4
|
3.6 Liters/second
Standard Error 0.3
|
|
Lung Function
month 12
|
3.1 Liters/second
Standard Error 0.5
|
3.3 Liters/second
Standard Error 0.5
|
3.3 Liters/second
Standard Error 0.3
|
4.0 Liters/second
Standard Error 0.7
|
|
Lung Function
month 6
|
3.1 Liters/second
Standard Error 0.3
|
3.3 Liters/second
Standard Error 0.5
|
2.9 Liters/second
Standard Error 0.3
|
3.7 Liters/second
Standard Error 0.3
|
Adverse Events
Air Purifier + IPM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham and no IPM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Air Purifier and no IPM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham and IPM
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