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

Deborah Gentile

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Usual care (albuterol with or without oral steroid); Drug: Nebulized Budesonide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00189436

BUD ER 3425

RC - 3425 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 61 patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Treatment with Budesonide

Active Comparator group

Description:

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Treatment:

Drug: Nebulized Budesonide

Usual care

Active Comparator group

Description:

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:

Drug: Usual care (albuterol with or without oral steroid)