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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: Budesonide
Drug: albuterol
Drug: Ipratropium bromide
Drug: Prednisone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • FEV1 [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospitalization [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

Enrollment: 96
Study Start Date: September 2007
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B
Budesonide, 2mg, 4 doses, plus standard care
 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
Placebo Comparator: P
Placebo plus standard care
 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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588406

Locations
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Nassau University Medical Center
East Meadow, New York, United States, 11554
Long Island Jewish Medical Center
Queens, New York, United States, 11042
Sponsors and Collaborators
North Shore Long Island Jewish Health System
AstraZeneca
Jacobi Medical Center
Nassau University Medical Center
Investigators
Principal Investigator: Robert Silverman, MD North Shore-LIJ Health System
  More Information

No publications provided

Responsible Party: Robert Silverman, MD, Long Island Jewish Medical Center
ClinicalTrials.gov Identifier: NCT00588406     History of Changes
Other Study ID Numbers: 07.02.019
Study First Received: December 21, 2007
Last Updated: March 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
acute, emergency department

Additional relevant MeSH terms:
Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Albuterol
Ipratropium
Budesonide
 Bromides
Prednisone
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents

ClinicalTrials.gov processed this record on October 17, 2012