Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
Information source: North Shore Long Island Jewish Health System
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Budesonide (Drug); albuterol (Drug); Ipratropium bromide (Drug); Prednisone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: North Shore Long Island Jewish Health System Official(s) and/or principal investigator(s):
Robert Silverman, MD, Principal Investigator, Affiliation: North Shore-LIJ Health System
Overall contact:
Reed Magleby, BS, Phone: 718-470-7501, Email: rmagleby@nshs.edu
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: FEV1
Secondary outcome: Hospitalization
Detailed description:
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Reed Magleby, BS, Phone: 718-470-7501, Email: rmagleby@nshs.edu
Long Island Jewish Medical Center, Queens, New York 11042, United States; Recruiting
Robert Silverman, MD, Principal Investigator
Jacobi Medical Center, Bronx, New York 10461, United States; Recruiting
Nassau University Medical Center, East Meadow, New York 11554, United States; Recruiting
Additional Information
Starting date: September 2007
Ending date: December 2009
Last updated: July 6, 2009
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