Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children

A Pilot Study to Evaluate the Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Pediatric Patients Following Discharge From the Emergency Department/Outpatient Care Facility

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.

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