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

Completed · Phase 4

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00189436

Run by

Deborah Gentile

People needed

61

Starts

2003-03-01

Expected to finish

2009-01-01

Last updated by the study team

2021-02-01

Who can join

Age: 1 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bellevue Pediatric Associates — Bellevue, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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