Trial Outcomes & Findings for ED-Initiated School-based Asthma Medication Supervision (NCT NCT03952286)
NCT ID: NCT03952286
Last Updated: 2025-11-19
Results Overview
90-day Emergency Department (ED) Recidivism as measured by the number of participants that return to the ED for asthma exacerbation within 90 days of discharge
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
90 days
Results posted on
2025-11-19
Participant Flow
Participant milestones
| Measure |
ED-Dispensing With Home and School Supervision
ED-Dispensing home and school supervision: 1. Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department), 2. 360 ug of budesonide inhalation powder once-daily for at-home use, and 3. albuterol sulfate as needed for relief of acute respiratory symptoms.
|
ED-Dispensing With Home Supervision
ED-Dispensing home supervision: 1. Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department), 2. 360 ug of budesonide inhalation powder once-daily for at-home use, and 3. albuterol sulfate as needed for relief of acute respiratory symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ED-Initiated School-based Asthma Medication Supervision
Baseline characteristics by cohort
| Measure |
ED-Dispensing With Home and School Supervision
n=6 Participants
ED-Dispensing home and school supervision: 1. Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department), 2. 360 ug of budesonide inhalation powder once-daily for at-home use, and 3. albuterol sulfate as needed for relief of acute respiratory symptoms.
|
ED-Dispensing With Home Supervision
n=7 Participants
ED-Dispensing home supervision: 1. Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department), 2. 360 ug of budesonide inhalation powder once-daily for at-home use, and 3. albuterol sulfate as needed for relief of acute respiratory symptoms.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.2 years
STANDARD_DEVIATION 0.89 • n=39 Participants
|
8.4 years
STANDARD_DEVIATION 1.86 • n=29 Participants
|
7.9 years
STANDARD_DEVIATION 1.57 • n=60 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
3 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
4 Participants
n=29 Participants
|
7 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=39 Participants
|
5 Participants
n=29 Participants
|
10 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
4 Participants
n=29 Participants
|
9 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 90 days90-day Emergency Department (ED) Recidivism as measured by the number of participants that return to the ED for asthma exacerbation within 90 days of discharge
Outcome measures
| Measure |
ED-Dispensing With Home and School Supervision
n=6 Participants
ED-Dispensing home and school supervision: 1. Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department), 2. 360 ug of budesonide inhalation powder once-daily for at-home use, and 3. albuterol sulfate as needed for relief of acute respiratory symptoms.
|
ED-Dispensing With Home Supervision
n=7 Participants
ED-Dispensing home supervision: 1. Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department), 2. 360 ug of budesonide inhalation powder once-daily for at-home use, and 3. albuterol sulfate as needed for relief of acute respiratory symptoms.
|
|---|---|---|
|
90-day Emergency Department (ED) Recidivism
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Cost-effectiveness analysis cannot be completed because an estimate of ED days averted was not collected due to low enrollment. Therefore, the cost-effectiveness outcome, which is dollars per averted ED visit, could not be calculated.
Cost-effectiveness as estimated by the dollars per averted ED visit
Outcome measures
Outcome data not reported
Adverse Events
ED-Dispensing With Home and School Supervision
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ED-Dispensing With Home Supervision
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
Dr. Ashley A. Lowe
University of Arizona Asthma & Airway Disease Research Center
Phone: 5206268814
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place