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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Usual care (albuterol with or without oral steroid); Drug: Nebulized Budesonide

• Registration Number: NCT00189436
• Lead Sponsor: Deborah Gentile

Brief 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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2014-07-08
• Results First Submitted QC: 2014-07-08
• Results First Posted: 2014-08-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care (albuterol with or without oral steroid)	Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.
Treatment with Budesonide	Nebulized Budesonide	Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Primary Outcome Measures

Name	Time	Method
Wheezing/Asthma/Bronchospasm Relapse Rate	3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 Second (FEV1)	3 weeks	This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care.
Urinary Cortisol Levels	3 weeks	This was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care).

Trial Locations

Locations (2)

Bellevue Pediatric Associates; 🇺🇸 Bellevue, Pennsylvania, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States