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

Study Overview
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Brief Summary
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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
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Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Nebulized Budesonide
* Drug: Usual care (albuterol with or without oral steroid)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment with Budesonide<br>Subject is treated with nebulized budesonide 0.5 BID for 3 weeks | Drug: Nebulized Budesonide<br>* Subject is treated with nebulized budesonide 0.5 BID for 3 weeks<br>|
| Active Comparator: Usual care<br>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. | Drug: Usual care (albuterol with or without oral steroid)<br>* Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma