Trial Outcomes & Findings for Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation (NCT NCT02725008)
NCT ID: NCT02725008
Last Updated: 2019-02-27
Results Overview
number of patients who experience any of the following outcomes - unplanned hospital admission for asthma symptoms, unplanned ED visit for asthma symptoms, unplanned urgent care visit for asthma symptoms, unplanned primary care physician visit for asthma symptoms, or prescription of a course of steroids
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
99 participants
Primary outcome timeframe
5 days
Results posted on
2019-02-27
Participant Flow
Pediatric Emergency Department
99 participants were enrolled, 2 participants underwent initial enrollment but were not randomized to a group, leaving 97 participants who were assigned to a study group.
Participant milestones
| Measure |
Control
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit
Dexamethasone
|
Investigational
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit
Dexamethasone
placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
51
|
|
Overall Study
COMPLETED
|
37
|
39
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
Control
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit
Dexamethasone
|
Investigational
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit
Dexamethasone
placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Admitted to hospital
|
0
|
1
|
Baseline Characteristics
Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation
Baseline characteristics by cohort
| Measure |
Control
n=46 Participants
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit
Dexamethasone
|
Investigational
n=51 Participants
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit
Dexamethasone
placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.4 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
7 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
8.4 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
51 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
PIS Score
PIS Score at ED arrival
|
4 units on a scale
STANDARD_DEVIATION 2 • n=5 Participants
|
5 units on a scale
STANDARD_DEVIATION 2.85 • n=7 Participants
|
4 units on a scale
STANDARD_DEVIATION 2.53 • n=5 Participants
|
|
PIS Score
PIS Score at End of ED Stay
|
2 units on a scale
STANDARD_DEVIATION 1.35 • n=5 Participants
|
1 units on a scale
STANDARD_DEVIATION 1.09 • n=7 Participants
|
1 units on a scale
STANDARD_DEVIATION 1.23 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysnumber of patients who experience any of the following outcomes - unplanned hospital admission for asthma symptoms, unplanned ED visit for asthma symptoms, unplanned urgent care visit for asthma symptoms, unplanned primary care physician visit for asthma symptoms, or prescription of a course of steroids
Outcome measures
| Measure |
Control
n=37 Participants
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit
Dexamethasone
|
Investigational
n=39 Participants
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit
Dexamethasone
placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
|
|---|---|---|
|
Treatment Failure
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Participants who had complete data available for analysis
Severity of asthma symptoms as reported by the Patient Self Assessment Score. Patients assessed severity of asthma symptoms in 4 categories (wheezing, coughing, activity and sleep) once per day during the 5 days between study enrollment and follow-up. Score range is 0 - 12 with 0 being mildest symptoms and 12 being most severe symptoms. Reported as change in score between enrollment (day 1) and follow-up (day 5).
Outcome measures
| Measure |
Control
n=22 Participants
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit
Dexamethasone
|
Investigational
n=11 Participants
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit
Dexamethasone
placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
|
|---|---|---|
|
Change in Symptom Severity From Day 1 to Day 5
|
-4 score on a scale
Standard Deviation 3.39
|
-4 score on a scale
Standard Deviation 3.29
|
Adverse Events
Control
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Investigational
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Control
n=46 participants at risk
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit
Dexamethasone
|
Investigational
n=51 participants at risk
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit
Dexamethasone
placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/46 • Duration of study participation - 5 days
|
2.0%
1/51 • Number of events 1 • Duration of study participation - 5 days
|
|
General disorders
Hospitalization
|
2.2%
1/46 • Number of events 1 • Duration of study participation - 5 days
|
0.00%
0/51 • Duration of study participation - 5 days
|
Other adverse events
| Measure |
Control
n=46 participants at risk
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit
Dexamethasone
|
Investigational
n=51 participants at risk
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit
Dexamethasone
placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
|
|---|---|---|
|
Gastrointestinal disorders
vomiting
|
2.2%
1/46 • Number of events 1 • Duration of study participation - 5 days
|
2.0%
1/51 • Number of events 1 • Duration of study participation - 5 days
|
Additional Information
Christopher P Kelly
New York Presbyterian - Brooklyn Methodist Hospital
Phone: 718.780.5040
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place