Status:
COMPLETED
Budesonide Inhalation Suspension for Acute Asthma in Children
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Asthma
Acute Asthma
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether the addition of budesonide inhalation suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic corticosteroids (SCS) f...
Detailed Description
Context: Acute asthma is a leading cause of emergency department (ED) visits and hospitalizations. Although standard therapy for acute asthma includes systemic corticosteroids (SCS), these drugs take ...
Eligibility Criteria
Inclusion
- Chief complaint of "respiratory distress", "asthma", "trouble breathing", or "reactive airway disease"
- Males or females age 2 to 18 years
- Weight greater than or equal to 10 kilograms
- Two or more prior Emergency Department or primary care visits for asthma or reactive airway disease
- Identified in triage as either "acute" or "critical"
- Asthma score of 8 or greater
- Systemic corticosteroid prescribed in the Emergency Department
- English-speaking parent/guardian present
- Parental/guardian permission (informed consent) and if appropriate, child assent
Exclusion
- Systemic corticosteroid use in the last 30 days
- Chronic lung diseases including cystic fibrosis
- Sickle cell anemia
- Immunodeficiency
- Cardiac disease requiring surgery or medications
- Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
- Known renal or hepatic dysfunction
- Exposure to varicella in the last 21 days
- Impending respiratory failure requiring positive pressure ventilation
- Altered level of consciousness
- Suspected foreign body aspiration or croup
- Prior enrollment in the study
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00393367
Start Date
December 1 2006
End Date
November 1 2007
Last Update
August 10 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Philadelphia Emergency Department
Philadelphia, Pennsylvania, United States, 19104