Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00588406
Recruitment Status : Completed
First Posted : January 8, 2008
Results First Posted : January 21, 2016
Last Update Posted : January 21, 2016
Sponsor:
Collaborators:
AstraZeneca
Jacobi Medical Center
Nassau University Medical Center
Information provided by (Responsible Party):
Robert A Silverman, Northwell Health

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE January 8, 2008
Results First Submitted Date  ICMJE October 12, 2015
Results First Posted Date  ICMJE January 21, 2016
Last Update Posted Date January 21, 2016
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
FEV1 Percent Predicted [ Time Frame: 4 hours post-randomization ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
FEV1 [ Time Frame: 6 hours ]
Change History Complete list of historical versions of study NCT00588406 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Hospitalization [ Time Frame: 6 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
Official Title  ICMJE 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
Brief Summary 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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2015)
95
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)
180
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00588406
Other Study ID Numbers  ICMJE 07.02.019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert A Silverman, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE
  • AstraZeneca
  • Jacobi Medical Center
  • Nassau University Medical Center
Investigators  ICMJE
Principal Investigator: Robert Silverman, MD Northwell Health
PRS Account Northwell Health
Verification Date December 2015

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