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| 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 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 |
| Estimated Enrollment: | 300 |
| 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 |
|---|---|
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016 | |
| 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: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00585039 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
child emergency department |
|
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 |