Budesonide for Emergency Treatment of Acute Wheezing in Children

Phase 4

Completed

• Conditions: Asthma; Acute Asthma
• Interventions: Drug: 0.5 mg/ml budesonide nebules; Drug: Saline

• Registration Number: NCT00733317
• Lead Sponsor: Kecioren Education and Training Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-12
• Study First Posted: 2008-08-13
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-17
• Last Update Posted: 2011-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-Budesonide nebulized suspension	0.5 mg/ml budesonide nebules	Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times and will not give after 3 doses
2- 0.9% saline	Saline	Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses

Primary Outcome Measures

Name	Time	Method
Pulmonary index score at 2 to 4 hours	2 to 4 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kecioren Education and Training Hospital; 🇹🇷 Ankara, Kecioren, Turkey