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Budesonide for Acute Wheezing in Children
NCT00733317Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2007
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- Keçiören Eğitim ve Araştırma Hastanesi
- Modality
- Orthosteric Ligands
- Drugs
- budesonide
01
Overview
Phase 4, randomised, double-blind trial comparing Budesonide with Placebo (2 arms). Primary endpoint: Pulmonary index score. Started Sep 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Budesonide
Nebulized budesonide + Standard Care
Placebo
Nebulized saline + Standard Care
03
Who it enrols
Children 6 months to 6 years old with recurrent wheezing attacks admitted to the ER with a Pulmonary Index Score of 7-13. Excludes those with recent systemic steroid use, chronic lung disease, immunodeficiency, or impending respiratory failure.
04
Endpoints
Primary
Pulmonary index score
Secondary
Hospital admission rates
Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild
Respiratory rate
Oxygen saturation
Time to discharge from the Emergency Department to home
Adverse reactions
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