NCT00733473

Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

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

• 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 children who have hospitalized for acute wheezing.

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 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.

Conditions

• Asthma
• Acute Asthma

Interventions

Type	Name	Description
DRUG	Budesonide 0.5 mg/ml nebules	Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days
DRUG	% 0.9 Saline solution	Children will receive 2 ml of nebulized saline 2 times a day up to 5 days

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2008-08-13
• Last updated: 2011-12-20

Locations

1 site across 1 country: Turkey (Türkiye)