Trial Outcomes & Findings for Aligning With Schools To Help Manage Asthma (Project ASTHMA) (NCT NCT03032744)
NCT ID: NCT03032744
Last Updated: 2026-02-09
Results Overview
Total number of days per week, over the previous 4 weeks, of asthma symptoms Minimum: 0 Maximum: 7 Lower number indicates improvement The change in number of days per week of asthma symptoms from baseline to 7-month follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Baseline, 1-month, 3-month, 5-month, 7-month
Results posted on
2026-02-09
Participant Flow
Participant milestones
| Measure |
Intervention
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment \& management'), and receive the morning dose of their daily asthma controller medication at school on school days.
Asthma Assessment \& Management: Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma Education: Asthma education on medications
Controller medication at school: Students will receive the morning dose of their daily preventive asthma medication at school on school days.
|
Usual Care
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.
Asthma Assessment \& Management: Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma Education: Asthma education on medications
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
16
|
|
Overall Study
COMPLETED
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aligning With Schools To Help Manage Asthma (Project ASTHMA)
Baseline characteristics by cohort
| Measure |
Intervention
n=13 Participants
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment \& management'), and receive the morning dose of their daily asthma controller medication at school on school days.
Asthma Assessment \& Management: Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma Education: Asthma education on medications
Controller medication at school: Students will receive the morning dose of their daily preventive asthma medication at school on school days.
|
Usual Care
n=16 Participants
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.
Asthma Assessment \& Management: Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma Education: Asthma education on medications
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.6 years
n=41 Participants
|
9.2 years
n=1581 Participants
|
8.9 years
n=4626 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
21 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=41 Participants
|
14 Participants
n=1581 Participants
|
24 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Asthma Control Test (ACT)
|
14.8 units on a scale
STANDARD_DEVIATION 4.27 • n=41 Participants
|
14.4 units on a scale
STANDARD_DEVIATION 4.96 • n=1581 Participants
|
14.6 units on a scale
STANDARD_DEVIATION 4.59 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1-month, 3-month, 5-month, 7-monthTotal number of days per week, over the previous 4 weeks, of asthma symptoms Minimum: 0 Maximum: 7 Lower number indicates improvement The change in number of days per week of asthma symptoms from baseline to 7-month follow-up
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment \& management'), and receive the morning dose of their daily asthma controller medication at school on school days.
Asthma Assessment \& Management: Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma Education: Asthma education on medications
Controller medication at school: Students will receive the morning dose of their daily preventive asthma medication at school on school days.
|
Usual Care
n=15 Participants
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.
Asthma Assessment \& Management: Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma Education: Asthma education on medications
|
|---|---|---|
|
Change in Number of Days Per Week, in the Previous 4 Weeks, of Daytime Asthma Symptoms From Baseline to 7-month Follow-up
|
-3.4 days per week
Interval -4.9 to -1.9
|
-2.8 days per week
Interval -4.1 to -1.2
|
SECONDARY outcome
Timeframe: Baseline, 1-month, 3-month, 5-month, 7-monthImprovement in ACT (Asthma Control Test) score, a validated questionnaire for the assessment of asthma symptoms, which is included in the NAEPP-EPR3 guidelines for components of control. Minimum value is 0. Maximum value is 27. Higher scores mean a better outcome. Scores less than 19 suggest not well-controlled asthma. The change in ACT score from baseline to 7-month follow-up
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment \& management'), and receive the morning dose of their daily asthma controller medication at school on school days.
Asthma Assessment \& Management: Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma Education: Asthma education on medications
Controller medication at school: Students will receive the morning dose of their daily preventive asthma medication at school on school days.
|
Usual Care
n=15 Participants
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.
Asthma Assessment \& Management: Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma Education: Asthma education on medications
|
|---|---|---|
|
Change in ACT Score From Baseline to 7-month Follow-up
|
6.4 score on a scale
Interval 3.2 to 9.4
|
8.3 score on a scale
Interval 5.1 to 10.8
|
SECONDARY outcome
Timeframe: Baseline, 1-month, 3-month, 5-month, 7-monthImprovement FEV1/FVC ratio on spirometry. Higher number is a better outcome. FEV1/FVC ratio is a calculation used in pulmonary function testing to help diagnose lung conditions, particularly obstructive and restrictive lung diseases. It represents the proportion of air a person can exhale in the first second of a forced expiration (FEV1 - forced expiratory volume in 1 second) compared to the total amount of air they can exhale with maximal effort (FVC - forced vital capacity). The change in FEV1/FVC ratio from baseline to 7-month follow-up.
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment \& management'), and receive the morning dose of their daily asthma controller medication at school on school days.
Asthma Assessment \& Management: Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma Education: Asthma education on medications
Controller medication at school: Students will receive the morning dose of their daily preventive asthma medication at school on school days.
|
Usual Care
n=15 Participants
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.
Asthma Assessment \& Management: Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma Education: Asthma education on medications
|
|---|---|---|
|
Change in FEV1/FVC Ratio From Baseline to 7-month Follow-up
|
0 ratio
Interval -0.01 to 0.04
|
-0.05 ratio
Interval -0.07 to -0.02
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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