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

Sponsor:	North Shore Long Island Jewish Health System
Collaborators:	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 Levalbuterol hydrochloride Albuterol sulfate Budesonide Ipratropium Levalbuterol tartrate

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

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

Contacts

Contact: Reed Magleby, BS	718-470-7501	rmagleby@nshs.edu
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:	July 6, 2009
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

Additional relevant MeSH terms:

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

Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Adrenergic beta-Agonists
Immune System Diseases
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids

ClinicalTrials.gov processed this record on November 27, 2009