Official Title: “Emergency Department Use of Nebulized Budesonide as an Adjunct to Standardized Therapy in Acutely Ill Adults With Refractory Asthma: a Randomized, Double-Blinded, Placebo-Controlled Trial”

To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve FEV1 and decrease the need for hospitalization.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Budesonide
  • 2mg/dose by nebulizer, four doses over 3 hours
• Drug: albuterol
  • 2.5mg/dose by nebulizer, 7 doses over 6 hours
• Drug: Ipratropium bromide
  • 2.5 mg, one dose
• Drug: Prednisone
  • 60mg PO

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: B
  • Budesonide, 2mg, 4 doses, plus standard care
• Placebo Comparator: P
  • Placebo plus standard care

Primary Measures

• FEV1
  • Time Frame: 6 hours
    Safety Issue?: Yes

Secondary Measures

• Hospitalization
  • Time Frame: 6 hours
    Safety Issue?: Yes

Inclusion Criteria:

• FEV1<50% predicted after bronchodilator therapy, age 18-60, presenting to an emergency department with acute asthma

Exclusion Criteria:

• other chronic lung disease, >15 pack years smoking

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: North Shore Long Island Jewish Health System

Overall Clinical Trial Officials and Contacts

Robert Silverman, MD Principal Investigator North Shore-LIJ Health System  

Overall Contact: Emily Baneman, BA 718-470-7501 emily.baneman@gmail.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00588406

Study ID Number: 07.02.019

ClinicalTrials.gov Identifier: NCT00588406

Health Authority: United States: Institutional Review Board