Asthma
Conditions
Keywords
Asthma, Pediatric, Emergency Department, Dexamethasone, Steroid
Brief summary
Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.
Detailed description
A randomized double blinded placebo controlled trial comparing one dose of dexamethasone administered in the Emergency Department with two doses, the first given in the emergency department and the second 24 hours after the index ED visit.
Interventions
DRUGDexamethasone
DRUGplacebo
to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
Sponsors
Geoffrey W Jara-Almonte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 20 Years
Healthy volunteers
No
Inclusion criteria
* History of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists
Exclusion criteria
* pregnancy * severe chronic cardiac, respiratory, neurological or neuromuscular disease * complete resolution of symptoms after one treatment of beta agonists * severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure | 5 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Severity From Day 1 to Day 5 | 5 days | 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). |
Countries
United States
Participant flow
Recruitment details
Pediatric Emergency Department
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 46 |
| 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 | 51 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Admitted to hospital | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 9 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Investigational | Total | Control |
|---|---|---|---|
| Age, Continuous | 7 years STANDARD_DEVIATION 5.4 | 8.4 years STANDARD_DEVIATION 5.7 | 9.4 years STANDARD_DEVIATION 6 |
| PIS Score PIS Score at ED arrival | 5 units on a scale STANDARD_DEVIATION 2.85 | 4 units on a scale STANDARD_DEVIATION 2.53 | 4 units on a scale STANDARD_DEVIATION 2 |
| PIS Score PIS Score at End of ED Stay | 1 units on a scale STANDARD_DEVIATION 1.09 | 1 units on a scale STANDARD_DEVIATION 1.23 | 2 units on a scale STANDARD_DEVIATION 1.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 55 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 15 Participants | 34 Participants | 19 Participants |
| Region of Enrollment United States | 51 participants | 97 participants | 46 participants |
| Sex: Female, Male Female | 19 Participants | 31 Participants | 12 Participants |
| Sex: Female, Male Male | 32 Participants | 66 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 1 / 51 |
| other Total, other adverse events | 1 / 46 | 1 / 51 |
| serious Total, serious adverse events | 1 / 46 | 1 / 51 |
Outcome results
Primary
Treatment Failure
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
Time frame: 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Treatment Failure | 6 Participants |
| Investigational | Treatment Failure | 3 Participants |
p-value: 0.395% CI: [0.54, 10.07]Chi-squared
Secondary
Change in Symptom Severity From Day 1 to Day 5
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).
Time frame: 5 days
Population: Participants who had complete data available for analysis
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Control | Change in Symptom Severity From Day 1 to Day 5 | -4 score on a scale | Standard Deviation 3.39 |
| Investigational | Change in Symptom Severity From Day 1 to Day 5 | -4 score on a scale | Standard Deviation 3.29 |
p-value: 0.95t-test, 2 sided