Budesonide Inhalation Suspension for Acute Asthma in Children

Completed · Phase 4 · Has a placebo group

Conditions studied: Asthma, Acute Asthma, Reactive Airway Exacerbation

In brief

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.

Key facts

Study ID

NCT00393367

Run by

Children's Hospital of Philadelphia

People needed

179

Starts

2006-12-01

Expected to finish

2007-11-01

Last updated by the study team

2012-08-10

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Philadelphia Emergency Department — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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