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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:
ClinicalTrials.gov Identifier:
NCT00588406
First Posted: January 8, 2008
Last Update Posted: January 21, 2016
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.
Collaborators:
AstraZeneca
Jacobi Medical Center
Nassau University Medical Center
Information provided by (Responsible Party):
Robert A Silverman, North Shore Long Island Jewish Health System
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Robert A Silverman, North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • FEV1 Percent Predicted [ Time Frame: 4 hours post-randomization ]

Secondary Outcome Measures:
  • Hospitalization [ Time Frame: 6 hours ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 21, 2007
First Posted: January 8, 2008
Results First Submitted: October 12, 2015
Results First Posted: January 21, 2016
Last Update Posted: January 21, 2016
Last Verified: December 2015

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


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