CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Nebulized Budesonide +1 moredrug
Likely dose
Nebulized budesonide 0.5 mg twice daily for 3 weeksAI-extracted
Key inclusion· 3
  • Children ages 1-8 years old
  • Discharge from emergency department or outpatient clinic with diagnosis of asthma exacerbation after standard care
  • Able to demonstrate efficient use of a jet nebulizer
Key exclusion· 7
  • Requiring hospitalization
  • Received oral steroids within 1 week prior to ED presentation
  • FEV1 <50% of predicted
  • Co-morbid renal or cardiovascular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00189436
NCT00189436Phase 4Completed

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

Deborah Gentile·interventional·Posted Sep 19, 2005·Updated Feb 1, 2021

In Brief

A Phase 4 clinical trial evaluating Nebulized Budesonide and Usual care (albuterol with or without oral steroid) for Asthma. Completed, enrolled 61 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartMar 1, 2003
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.8 years ago

Interventions

Nebulized Budesonidedrug

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Usual care (albuterol with or without oral steroid)drug

Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)