Official Title: “Budesonide Inhalation Suspension for Acute Asthma in Children”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2007

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 many hours to have an effect. Recent studies demonstrate that inhaled corticosteroids (ICS) may improve patients' asthma severity more rapidly than SCS and may decrease hospitalizations. Only a few small studies have evaluated ICS added to standard therapy for acute asthma in children.

Objective: To determine if adding the nebulized steroid budesonide to standard therapy including SCS improves patients' asthma severity faster than standard therapy alone and leads to fewer hospitalizations.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of budesonide inhalation suspension (BIS) versus placebo for children 2 to 18 years of age who present to a tertiary care, urban pediatric ED with a moderate to severe asthma flare.

Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.

Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.

Intervention(s) in this Clinical Trial

• Drug: Budesonide inhalation suspension (0.5 mg/2mL)
  • participants will receive standard therapy including systemic corticosteroids (SCS,albuterol and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS (inhalation suspension 0.5mg/2ml)or saline

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • standardized treatment with nebulized BIS versus standardized treatment with nebulized saline

Primary Measures

• Median asthma score at 2 hours.
  • Time Frame: 2 hours
    Safety Issue?: No

Secondary Measures

• Hospital admission rates.
  • Time Frame: within 4 hours
    Safety Issue?: No
• Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.
  • Time Frame: 2 hours
    Safety Issue?: No
• Heart rate.
  • Time Frame: 1 hour
    Safety Issue?: No
• Respiratory rate.
  • Time Frame: 1 hour
    Safety Issue?: No
• Oxygen saturation.
  • Time Frame: 1 hour
    Safety Issue?: No
• Time to discharge from the Emergency Department to home.
  • Time Frame: 2 to 4 hours
    Safety Issue?: No
• Relapse / readmission rates.
  • Time Frame: within 5 days
    Safety Issue?: No
• Adverse reactions.
  • Time Frame: within 0 - 5 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Children's Hospital of Philadelphia

Overall Clinical Trial Officials and Contacts

Cynthia J Mollen, M.D. Principal Investigator Children's Hospital of Philadelphia  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00393367

Study ID Number: 2006-8-4875

ClinicalTrials.gov Identifier: NCT00393367

Health Authority: United States: Institutional Review Board