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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment with Budesonide

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Group Type ACTIVE_COMPARATOR

Nebulized Budesonide

Intervention Type DRUG

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Usual care

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.

Group Type ACTIVE_COMPARATOR

Usual care (albuterol with or without oral steroid)

Intervention Type DRUG

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

Interventions

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Nebulized Budesonide

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No