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

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Jacobi Medical Center
Nassau University Medical Center
Information provided by (Responsible Party):
Robert A Silverman, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00588406
First received: December 21, 2007
Last updated: December 15, 2015
Last verified: December 2015

December 21, 2007
December 15, 2015
September 2007
December 2009   (final data collection date for primary outcome measure)
FEV1 Percent Predicted [ Time Frame: 4 hours post-randomization ] [ Designated as safety issue: Yes ]
FEV1 [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
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 (ED) 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 forced expiratory volume at one second (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.
 
Completed
95
December 2009
December 2009   (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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588406
07.02.019
No
Not Provided
Not Provided
Robert A Silverman, North Shore Long Island Jewish Health System
Northwell Health
  • AstraZeneca
  • Jacobi Medical Center
  • Nassau University Medical Center
Principal Investigator: Robert Silverman, MD Northwell Health
Northwell Health
December 2015

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