Budesonide for Emergency Treatment of Acute Wheezing in Children

Study Overview
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Brief Summary
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The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in the emergency room.

Detailed Description
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Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. There is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids. Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in the emergency room has any benefit on, symptom score, hospitalization rate and time to discharge from emergency room. Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the emergency room for acute wheezing. Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline. Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.

Official Title
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Phase 4 Study of Budesonide for Emergency Treatment of Acute Wheezing in Children

Conditions
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Asthma, Acute Asthma

Intervention / Treatment
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* Drug: 0.5 mg/ml budesonide nebules
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who have recurrent wheezing attacks and admitted to the emergency room for acute wheezing Pulmonary index score of 7-13 Parental/guardian permission (informed consent) and if appropriate, child assent Exclusion Criteria: Systemic corticosteroid use in the last 30 days Chronic lung diseases including cystic fibrosis Immunodeficiency Cardiac disease requiring surgery or medications Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone Known renal or hepatic dysfunction Impending respiratory failure requiring positive pressure ventilation Immune deficiency Gastroesophageal reflux disease Suspected foreign body aspiration or croup Anatomic abnormalities of the respiratory tract

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-Budesonide nebulized suspension<br>Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times and will not give after 3 doses | Drug: 0.5 mg/ml budesonide nebules<br>* Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times<br>* Other names: Budesonide 0.5 mg/ml nebules;|
| Placebo Comparator: 2- 0.9% saline<br>Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses | Drug: Saline<br>* Children will receive 2 ml of saline every 20 minutes for 3 times<br>* Other names: 0.9% Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary index score at 2 to 4 hours |  | 2 to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital admission rates |  | 4 hours | 
| Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild. |  | 4 hours | 
| Respiratory rate |  | 2 hours | 
| Oxygen saturation |  | 2 hours | 
| Time to discharge from the Emergency Department to home |  | 2 to 4 hours | 
| Adverse reactions. |  | 2-5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wheezing, Acute asthma, Children, Budesonide, Emergency room