Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED) - Full Text View

Purpose

To determine in a large, double-blind, randomized, prospective pediatric clinical trial whether the use of continuous levalbuterol in addition to standard emergency department treatment for acute asthma exacerbations will improve FEV 1 compared to the use of continuous racemic albuterol. The secondary objective is to correlate clinical (hospitalization rates and clinical asthma scores) with plasma levels of (S)-albuterol.

Condition	Intervention	Phase
Asthma	Drug: xopenex	Phase IV

MedlinePlus related topics:

Asthma

Drug Information available for:

Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study

Official Title:	Comparison of Hospital Admission Rates and Plasma(s)-Albuterol Levels in Children Treated With Racemic Albuterol Versus Levalbuterol for Acute Asthma Exacerbations: A Randomized Double-Blind Clinical Trial

Further study details as provided by Phoenix Children's Hospital:

Primary Outcome Measures:

FEV1 [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma R and S isomer levels [ Time Frame: one time on a blood draw ] [ Designated as safety issue: No ]
clinical asthma scores [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
A: Experimental levalbuterol nebulization	Drug: xopenex will receive xopenex rather than albuterol to treat acute exacerbation

Show Detailed Description

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is between the ages of 6 and 17
Has previously been diagnosed with asthma by any physician
Has presented to the ED with an asthma exacerbation judged by a physician to be of a moderate or severe degree

Exclusion Criteria:

Requires immediate resuscitation (attending physician)
Is pregnant and/or breast feeding
If possibly pregnant, negative pregnancy test attached
Has chronic lung diseases (i.e. cystic fibrosis)
Has an uncorrected congenital heart diseaseHas a suspected foreign body aspiration
Is allergic to albuterol and/or levalbuterol (Xopenex)
Has an initial FEV 1>70% predicted

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585039

Contacts


Contact: Robert Bulloch, MD	602-546-1930	bbulloch@phoenixchildrens.com

Contact: Matt Wilkinson, MD	602-546-1932	mwilkinson@phoenixchildrens.com

Locations


United States, Arizona
	Phoenix Children's Hospital	Recruiting
	Phoenix, Arizona, United States, 85016
	Contact: Robert Bulloch, MD 602-546-1930 bbulloch@phoenixchildrens.com
	Principal Investigator: Robert Bulloch, MD

Sponsors and Collaborators

Phoenix Children's Hospital

Investigators


Principal Investigator:	Robert Bulloch, MD	Phoenix Children's Hospital

More Information

Responsible Party:	Phoenix Children's Hospital ( Robert Bulloch, MD )
Study ID Numbers:	SRC176
First Received:	December 20, 2007
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00585039
Health Authority:	United States: Food and Drug Administration

Keywords provided by Phoenix Children's Hospital:

child

emergency department

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Albuterol

Hypersensitivity, Immediate

Emergencies

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Bronchial Diseases

Immune System Diseases

Adrenergic beta-Agonists

Physiological Effects of Drugs

Anti-Asthmatic Agents

Reproductive Control Agents

Adrenergic Agonists

Pharmacologic Actions

Tocolytic Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Phoenix Children's Hospital
Information provided by:	Phoenix Children's Hospital
ClinicalTrials.gov Identifier:	NCT00585039