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

Sponsor:	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 (Xopenex) in addition to standard emergency department treatment for acute asthma exacerbations will improve the Forced Expiratory Volume in 1 sec (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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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:

Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec [ Time Frame: Baseline and 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Asthma Score (CAS) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Change in clinical asthma score while in ED. 15 point clinical asthma score. Score ranges from 5 (no to mild respiratory distress) to a maximum of 15 (severe respiratory distress).

Enrollment:	101
Study Start Date:	September 2005
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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

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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

Locations

United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016

Sponsors and Collaborators

Phoenix Children's Hospital

Investigators

Principal Investigator:

Robert Bulloch, MD

Phoenix Children's Hospital

More Information

No publications provided

Responsible Party:	Robert Bulloch, MD, Phoenix Children's Hospital
ClinicalTrials.gov Identifier:	NCT00585039 History of Changes
Other Study ID Numbers:	SRC176
Study First Received:	December 20, 2007
Results First Received:	March 17, 2011
Last Updated:	September 2, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Phoenix Children's Hospital:

child
emergency department

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012