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

Asthma Clinical Trial

— BudER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189436
• Other study ID #: BUD ER 3425
• Secondary ID: RC - 3425
• Status: Completed
• Phase: Phase 4
• Start date: March 2003
• Est. completion date: January 2009

Study information

• Verified date: January 2021
• Source: West Penn Allegheny Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

Inclusion Criteria:

• Children ages 1-8 years old

• Discharge from emergency department/outpatient clinic with a diagnosis of asthma exacerbation after usual standard care

• Subjects must be able to show efficient use with a jet nebulizer

Exclusion Criteria:

• Subjects requiring hospitalization

• Subjects receiving oral steroids 1 week prior to presentation to emergency department.

• Subjects with FEV1 < 50% of predicted

• Subjects with co-morbid medical conditions (renal or cardiovascular disease)

• Subjects with reported history of HIV

• Subjects unable to follow up for study visits

• Subjects who are frequently enuretic

Related Conditions & MeSH terms

• Asthma
• Respiratory Sounds

Intervention

Drug:
• Nebulized Budesonide
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
• 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)

Locations

Country	Name	City	State
United States	Bellevue Pediatric Associates	Bellevue	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Deborah Gentile	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wheezing/Asthma/Bronchospasm Relapse Rate	This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period.	3 weeks
Secondary	Urinary Cortisol Levels	This was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care).	3 weeks
Secondary	Forced Expiratory Volume in 1 Second (FEV1)	This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care.	3 weeks