Asthma
Conditions
Keywords
Asthma
Brief summary
Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.
Detailed description
Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.
Interventions
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
DRUGUsual care (albuterol with or without oral steroid)
Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)
Sponsors
AstraZeneca
Deborah Gentile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Children ages 1-8 years old * Discharge from emergency department/outpatient clinic with a diagnosis of asthma exacerbation after usual standard care * Subjects must be able to show efficient use with a jet nebulizer
Exclusion criteria
* Subjects requiring hospitalization * Subjects receiving oral steroids 1 week prior to presentation to emergency department. * Subjects with FEV1 \< 50% of predicted * Subjects with co-morbid medical conditions (renal or cardiovascular disease) * Subjects with reported history of HIV * Subjects unable to follow up for study visits * Subjects who are frequently enuretic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wheezing/Asthma/Bronchospasm Relapse Rate | 3 weeks | This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Cortisol Levels | 3 weeks | This was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care). |
| Forced Expiratory Volume in 1 Second (FEV1) | 3 weeks | This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Budesonide Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks | 31 |
| Usual Care Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.
Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid) | 30 |
| Total | 61 |
Baseline characteristics
| Characteristic | Treatment With Budesonide | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 4.8 years STANDARD_DEVIATION 2 | 5.4 years STANDARD_DEVIATION 1.6 | 5.1 years STANDARD_DEVIATION 0.084 |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 18 Participants | 20 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
Primary
Wheezing/Asthma/Bronchospasm Relapse Rate
This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period.
Time frame: 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Budesonide | Wheezing/Asthma/Bronchospasm Relapse Rate | 8.7 percentage of cases of asthma relapse |
| Usual Care | Wheezing/Asthma/Bronchospasm Relapse Rate | 4.0 percentage of cases of asthma relapse |
Secondary
Forced Expiratory Volume in 1 Second (FEV1)
This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Budesonide | Forced Expiratory Volume in 1 Second (FEV1) | 86.2 % Predicted | Standard Deviation 2.5 |
| Usual Care | Forced Expiratory Volume in 1 Second (FEV1) | 85.7 % Predicted | Standard Deviation 3.1 |
Secondary
Urinary Cortisol Levels
This was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care).
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Budesonide | Urinary Cortisol Levels | 95.4 ng cortisol/mg creatinine | Standard Deviation 35.3 |
| Usual Care | Urinary Cortisol Levels | 141.6 ng cortisol/mg creatinine | Standard Deviation 42.7 |