Use of Dexamethasone in Pediatric Asthma Exacerbations

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs. two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University at Buffalo
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Children aged 2 to 20 years, from all race and ethnicity groups, with a known history of asthma who present to the Emergency Department of Women and Children's Hospital of Buffalo with an acute exacerbation of mild or moderate asthma are potentially eligible for the study. Patients with severe asthma exacerbations will require intravenous steroid therapy, therefore, they will not be enrolled in the study. The investigators plan to enroll patients from winter of 2014 to fall 2016.

History of asthma is defined by physician diagnosis of at least 1 prior episode of wheezing which responded to beta agonist medication.

Mild asthma is defined as: Pediatric Asthma Score (PAS) of 5 to 7; Moderate asthma is defined as: PAS of 8 to 11; Severe asthma is defined as: PAS of 12 or more.

Exclusion Criteria:

• Children who have one of the following conditions will be excluded from the study: are less than 2 years of age, have signs of severe exacerbation (Pediatric Asthma Score of more than 11), have used oral steroids in the last 2 weeks, have chronic lung disease (e.g., cystic fibrosis), have been given IV solumedrol, or vomit two doses of dexamethasone in emergency department.