Status:
COMPLETED
Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
Lead Sponsor:
Deborah Gentile
Collaborating Sponsors:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
1-8 years
Phase:
PHASE4
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...
Detailed Description
Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00189436
Start Date
March 1 2003
End Date
January 1 2009
Last Update
February 1 2021
Active Locations (2)
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1
Bellevue Pediatric Associates
Bellevue, Pennsylvania, United States, 15202
2
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212