Overview
Budesonide Inhalation Suspension for Acute Asthma in Children
Status:
Completed
Completed
Trial end date:
2007-11-01
2007-11-01
Target enrollment:
0
0
Participant gender:
All
All
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) for moderate to severe asthma flares in children reduces asthma severity more rapidly than standard therapy alone.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Children's Hospital of PhiladelphiaTreatments:
Albuterol
Bromides
Budesonide
Ipratropium
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Criteria
Inclusion Criteria:- 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 Criteria:
- 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