NCT00189436

Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children

A Pilot Study to Evaluate the Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Pediatric Patients Following Discharge From the Emergency Department/Outpatient Care Facility

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Deborah Gentile · Academic / Other
• Sex: All
• Age: 1 Year – 8 Years
• Healthy volunteers: Not accepted

Summary

Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.

Detailed description

Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Nebulized Budesonide	Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
DRUG	Usual care (albuterol with or without oral steroid)	Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)

Timeline

• Start date: 2003-03-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2005-09-19
• Last updated: 2021-02-01
• Results posted: 2014-08-04

Locations

2 sites across 1 country: United States