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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
  Purpose
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.

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 (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

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • FEV1 Percent Predicted [ Time Frame: 4 hours post-randomization ] [ Designated as safety issue: Yes ]

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

Enrollment: 95
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Northwell Health
AstraZeneca
Jacobi Medical Center
Nassau University Medical Center
Investigators
Principal Investigator: Robert Silverman, MD Northwell Health
  More Information

Responsible Party: Robert A Silverman, Physician, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00588406     History of Changes
Other Study ID Numbers: 07.02.019 
Study First Received: December 21, 2007
Results First Received: October 12, 2015
Last Updated: December 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Northwell Health:
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
Budesonide
Prednisone
Ipratropium
Albuterol
Bromides
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Cholinergic Antagonists

ClinicalTrials.gov processed this record on September 30, 2016