Emergency Department Use of Nebulized Budesonide as an Adjunct to Standardized Therapy in Acutely Ill Adults With Refractory Asthma

This study is currently recruiting participants.

Verified by North Shore Long Island Jewish Health System, December 2008

First Received: December 21, 2007 Last Updated: December 10, 2008 History of Changes

Sponsors and Collaborators:	North Shore Long Island Jewish Health System AstraZeneca Jacobi Medical Center Nassau University Medical Center
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00588406

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Prednisone Albuterol Ipratropium bromide Budesonide Ipratropium

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 ]

Estimated Enrollment:	180
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Experimental Budesonide, 2mg, 4 doses, plus standard care	Drug: Budesonide 2mg/dose by nebulizer, four doses over 3 hours Drug: albuterol 2.5mg/dose by nebulizer, 7 doses over 6 hours Drug: Ipratropium bromide 2.5 mg, one dose Drug: Prednisone 60mg PO
P: Placebo Comparator Placebo plus standard care	Drug: albuterol 2.5mg/dose by nebulizer, 7 doses over 6 hours Drug: Ipratropium bromide 2.5 mg, one dose Drug: Prednisone 60mg PO

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

Contacts

Contact: Emily Baneman, BA	718-470-7501	emily.baneman@gmail.com
Contact: Robert Silverman, MD	718-470-7501	rsilverm@lij.edu

Locations

United States, New York
Long Island Jewish Medical Center	Recruiting
Queens, New York, United States, 11042
Principal Investigator: Robert Silverman, MD
Jacobi Medical Center	Recruiting
Bronx, New York, United States, 10461
Nassau University Medical Center	Recruiting
East Meadow, New York, United States, 11554

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:	Long Island Jewish Medical Center ( Robert Silverman, MD )
Study ID Numbers:	07.02.019
Study First Received:	December 21, 2007
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00588406 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:

acute, emergency department

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Neurotransmitter Agents
Bronchial Diseases
Cholinergic Antagonists
Hormone Antagonists
Albuterol
Hormones, Hormone Substitutes, and Hormone Antagonists
Cholinergic Agents
Hormones
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases

Bromides
Antineoplastic Agents, Hormonal
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Ipratropium
Lung Diseases
Hypersensitivity, Immediate
Emergencies
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Respiratory System Agents
Neurotransmitter Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Cholinergic Antagonists
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cholinergic Agents
Hormones
Hypersensitivity
Lung Diseases, Obstructive

Pathologic Processes
Respiratory Tract Diseases
Therapeutic Uses
Antineoplastic Agents, Hormonal
Immune System Diseases
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Ipratropium
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Emergencies

ClinicalTrials.gov processed this record on July 02, 2009