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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deborah Gentile; West Penn Allegheny Health System
• Collaborator: AstraZeneca
• Treatments: Albuterol; Budesonide

Criteria

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