Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)

This study is currently recruiting participants.

Verified by Phoenix Children's Hospital, February 2009

First Received: December 20, 2007 Last Updated: February 4, 2009 History of Changes

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

Purpose

The purpose of this study is 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

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

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

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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

No publications provided

Responsible Party:	Phoenix Children's Hospital ( Robert Bulloch, MD )
Study ID Numbers:	SRC176
Study First Received:	December 20, 2007
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00585039 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Phoenix Children's Hospital:

child
emergency department

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Bronchial Diseases
Albuterol
Asthma
Anti-Asthmatic Agents
Adrenergic Agonists
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Emergencies
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tocolytic Agents

Therapeutic Uses
Immune System Diseases
Adrenergic beta-Agonists
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on July 02, 2009