NCT00733317

Budesonide for Emergency Treatment of Acute Wheezing in Children

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Kecioren Education and Training Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma
• Acute Asthma

Interventions

Type	Name	Description
DRUG	0.5 mg/ml budesonide nebules	Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times
DRUG	Saline	Children will receive 2 ml of saline every 20 minutes for 3 times

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-08-13
• Last updated: 2011-12-20

Locations

1 site across 1 country: Turkey (Türkiye)