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.
Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
61
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)
Bellevue Pediatric Associates
Bellevue, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
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
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
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
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