Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.

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.

This is a randomized clinical trial studying the effect of nebulized budesonide (Pulmicort) in acutely ill adults presenting to the Emergency Department with severe asthma. Budesonide is an inhaled steroid FDA approved for the treatment of pediatric chronic asthma. ED entry criteria include hyporesponsiveness to nebulized beta-agonists and an FEV1<50% predicted.

The trial will evaluate the efficacy of multiple doses of nebulized budesonide as an adjunct to a highly regimented standardized treatment protocol; standard care consists of bronchodilators (beta-agonists/anticholinergics), systemic steroids, and intravenous magnesium sulfate (if the FEV1<25% predicted). The primary efficacy endpoint will be the FEV1 4 hours after administration of the study intervention. An additional safety and efficacy endpoint will take place at 5 hours after study intervention. The treatments will be coupled with a protocol-defined assessment regimen, with endpoints measured before each treatment and on ED disposition (at 5 hours after study intervention).

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 Investigator: North Shore Long Island Jewish Health System Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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