Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

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 children who have hospitalized for acute wheezing.

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 hospitalized children has any benefit on, symptom score, duration of hospitalization and time to discharge from hospital. 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 hospital 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, duration of hospitalization and time to discharge from hospital will be compared between treatment groups.

Official Title
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Phase 4 Study of Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

Conditions
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Asthma, Acute Asthma

Intervention / Treatment
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* Drug: Budesonide 0.5 mg/ml nebules
* Drug: % 0.9 Saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who have recurrent wheezing attacks Children who admitted to the hospital for acute wheezing Clinical asthma score of 3-9 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<br>This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 1 mg nebulized budesonide 2 times a day upto 5 days | Drug: Budesonide 0.5 mg/ml nebules<br>* Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days<br>* Other names: Pulmicort 0.5 mg/ml nebules;|
| Placebo Comparator: 2 Placebo saline<br>This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 2ml of nebulized saline 2 times a day upto 5 days | Drug: % 0.9 Saline solution<br>* Children will receive 2 ml of nebulized saline 2 times a day up to 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge from the hospital to home |  | 1-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary index score |  | 1 to 5 days | 
| Respiratory rate |  | 1 to 5 days | 
| Oxygen saturation |  | 1 to 5 days | 
| Adverse reactions. |  | 1 to 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