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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by North Shore Long Island Jewish Health System.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
AstraZeneca
Jacobi Medical Center
Nassau University Medical Center
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00588406
First received: December 21, 2007
Last updated: March 11, 2010
Last verified: March 2010

December 21, 2007
March 11, 2010
September 2007
March 2012   (final data collection date for primary outcome measure)
FEV1 [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00588406 on ClinicalTrials.gov Archive Site
Hospitalization [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: Budesonide
    2mg/dose by nebulizer, four doses over 3 hours
    Other Name: Pulmicort Respules
  • Drug: albuterol
    2.5mg/dose by nebulizer, 7 doses over 6 hours
    Other Names:
    • proventil
    • proair
    • ventolin
    • salbutamol
  • Drug: Ipratropium bromide
    2.5 mg, one dose
    Other Name: Atrovent
  • Drug: Prednisone
    60mg PO
    Other Name: deltasone
  • Experimental: B
    Budesonide, 2mg, 4 doses, plus standard care
    Interventions:
    • Drug: Budesonide
    • Drug: albuterol
    • Drug: Ipratropium bromide
    • Drug: Prednisone
  • Placebo Comparator: P
    Placebo plus standard care
    Interventions:
    • Drug: albuterol
    • Drug: Ipratropium bromide
    • Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
96
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588406
07.02.019
No
Robert Silverman, MD, Long Island Jewish Medical Center
North Shore Long Island Jewish Health System
  • AstraZeneca
  • Jacobi Medical Center
  • Nassau University Medical Center
Principal Investigator: Robert Silverman, MD North Shore-LIJ Health System
North Shore Long Island Jewish Health System
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP