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

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

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
Study 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 January 16, 2009