Trial Outcomes & Findings for Use of Dexamethasone in Pediatric Asthma Exacerbations (NCT NCT02192827)
NCT ID: NCT02192827
Last Updated: 2023-03-30
Results Overview
The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
318 participants
Primary outcome timeframe
5 days
Results posted on
2023-03-30
Participant Flow
Patients presenting with asthma symptoms to a single pediatric emergency department
Excluded 10 Patients: Previously enrolled into the study: 2 Admitted to the PICU (pediatric intensive care unit): 5 Required IV steroids in the Emergency Dept: 1 Steroid use within the last 2 weeks: 1 Excessive vomiting in the Emergency Dept: 1
Participant milestones
| Measure |
Single Dose Dexamethasone
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once
Dexamethasone Sodium Phosphate Injection
|
Two Dose Dexamethasone
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.
Dexamethasone Sodium Phosphate Injection
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
154
|
|
Overall Study
COMPLETED
|
116
|
116
|
|
Overall Study
NOT COMPLETED
|
38
|
38
|
Reasons for withdrawal
| Measure |
Single Dose Dexamethasone
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once
Dexamethasone Sodium Phosphate Injection
|
Two Dose Dexamethasone
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.
Dexamethasone Sodium Phosphate Injection
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
25
|
27
|
|
Overall Study
Given additional steroids with admission
|
13
|
11
|
Baseline Characteristics
PAS scores not available for all participants
Baseline characteristics by cohort
| Measure |
Single Dose Dexamethasone
n=116 Participants
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once
Dexamethasone Sodium Phosphate Injection
|
Two Dose Dexamethasone
n=116 Participants
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.
Dexamethasone Sodium Phosphate Injection
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.8 years
STANDARD_DEVIATION 3.9 • n=116 Participants
|
8.2 years
STANDARD_DEVIATION 4.4 • n=116 Participants
|
7.5 years
STANDARD_DEVIATION 4.2 • n=232 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=116 Participants
|
44 Participants
n=116 Participants
|
92 Participants
n=232 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=116 Participants
|
72 Participants
n=116 Participants
|
140 Participants
n=232 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=116 Participants
|
2 Participants
n=116 Participants
|
3 Participants
n=232 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=116 Participants
|
5 Participants
n=116 Participants
|
10 Participants
n=232 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=116 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=232 Participants
|
|
Race (NIH/OMB)
Black or African American
|
61 Participants
n=116 Participants
|
52 Participants
n=116 Participants
|
113 Participants
n=232 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=116 Participants
|
33 Participants
n=116 Participants
|
61 Participants
n=232 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=116 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=232 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=116 Participants
|
24 Participants
n=116 Participants
|
45 Participants
n=232 Participants
|
|
Tobacco exposure in home
|
32 Participants
n=116 Participants
|
31 Participants
n=116 Participants
|
63 Participants
n=232 Participants
|
|
Number of days with symptoms
|
3.6 days
STANDARD_DEVIATION 9.7 • n=116 Participants
|
3.1 days
STANDARD_DEVIATION 7.5 • n=116 Participants
|
3.3 days
STANDARD_DEVIATION 8.7 • n=232 Participants
|
|
Current use of asthma controller medication
|
50 Participants
n=116 Participants
|
54 Participants
n=116 Participants
|
104 Participants
n=232 Participants
|
|
Number of previous hospital admissions
|
1.4 admissions
STANDARD_DEVIATION 1.9 • n=116 Participants
|
1.2 admissions
STANDARD_DEVIATION 2.5 • n=116 Participants
|
1.3 admissions
STANDARD_DEVIATION 2.2 • n=232 Participants
|
|
Pediatric Asthma Score before albuterol administered
|
7.2 PAS score
STANDARD_DEVIATION 1.8 • n=106 Participants • PAS scores not available for all participants
|
6.9 PAS score
STANDARD_DEVIATION 1.5 • n=107 Participants • PAS scores not available for all participants
|
7.1 PAS score
STANDARD_DEVIATION 1.6 • n=213 Participants • PAS scores not available for all participants
|
PRIMARY outcome
Timeframe: 5 daysThe investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician.
Outcome measures
| Measure |
Single Dose Dexamethasone
n=116 Participants
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once
Dexamethasone Sodium Phosphate Injection
|
Two Dose Dexamethasone
n=116 Participants
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.
Dexamethasone Sodium Phosphate Injection
|
|---|---|---|
|
Number of Participants Returning to Care Following Discharge From the Emergency Department
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 5 daysWill determine number of days to symptom resolution, including missed school days.
Outcome measures
| Measure |
Single Dose Dexamethasone
n=116 Participants
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once
Dexamethasone Sodium Phosphate Injection
|
Two Dose Dexamethasone
n=116 Participants
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.
Dexamethasone Sodium Phosphate Injection
|
|---|---|---|
|
Reported Number of Days Until Symptom Resolution
|
2.4 Days
Standard Deviation 3.5
|
2.5 Days
Standard Deviation 3.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysThe investigators will determine during phone follow up if patient experienced any side effects related to the Dexamethasone, including vomiting, mood swings, behavior changes, appetite changes, sweating or headache.
Outcome measures
| Measure |
Single Dose Dexamethasone
n=116 Participants
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once
Dexamethasone Sodium Phosphate Injection
|
Two Dose Dexamethasone
n=116 Participants
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.
Dexamethasone Sodium Phosphate Injection
|
|---|---|---|
|
Reported Side Effects Experienced by Participants
Headache
|
3 Participants
|
1 Participants
|
|
Reported Side Effects Experienced by Participants
Multiple
|
17 Participants
|
18 Participants
|
|
Reported Side Effects Experienced by Participants
No side effects
|
71 Participants
|
83 Participants
|
|
Reported Side Effects Experienced by Participants
Decreased Appetite
|
4 Participants
|
7 Participants
|
|
Reported Side Effects Experienced by Participants
Difficulty Sleeping
|
9 Participants
|
0 Participants
|
|
Reported Side Effects Experienced by Participants
Mood swings/Agitation
|
7 Participants
|
3 Participants
|
|
Reported Side Effects Experienced by Participants
Other
|
5 Participants
|
4 Participants
|
Adverse Events
Single Dose Dexamethasone
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Two Doses of Dexamethasone
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Dose Dexamethasone
n=116 participants at risk
This group was the standard arm and received one single dose of dexamethasone in the Emergency department
|
Two Doses of Dexamethasone
n=116 participants at risk
This group was the intervention group and received a dose of dexma
|
|---|---|---|
|
Gastrointestinal disorders
Decreased Appetite
|
3.4%
4/116 • 5 days
|
6.0%
7/116 • 5 days
|
|
General disorders
Difficulty sleeping
|
7.8%
9/116 • 5 days
|
0.00%
0/116 • 5 days
|
|
Psychiatric disorders
Moodswing/Agitation
|
6.0%
7/116 • 5 days
|
2.6%
3/116 • 5 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place