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| 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 |
| 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 |
| Estimated Study Completion Date: | December 2009 |
| Arms | Assigned Interventions |
|
A: Experimental
levalbuterol nebulization
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Drug: xopenex
will receive xopenex rather than albuterol to treat acute exacerbation
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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| Contact: Robert Bulloch, MD | 602-546-1930 | bbulloch@phoenixchildrens.com |
| Contact: Matt Wilkinson, MD | 602-546-1932 | mwilkinson@phoenixchildrens.com |
| 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 | |||||
| Phoenix Children's Hospital |
| 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 |
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