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Sponsors and Collaborators: |
Children's Hospital of Philadelphia Sepracor, Inc. |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00124176 |
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma.
Primary hypothesis
Secondary hypotheses
Condition | Intervention | Phase |
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Asthma |
Drug: Racemic albuterol Drug: Levalbuterol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Continuous Levalbuterol for Treatment of Status Asthmaticus in Children |
Enrollment: | 81 |
Study Start Date: | April 2004 |
Study Completion Date: | February 2006 |
Arms | Assigned Interventions |
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1: Experimental
Continuous levalbuterol
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Drug: Levalbuterol
10mg/hr continuous nebulized levalbuterol
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2: Active Comparator
Continuous racemic albuterol
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Drug: Racemic albuterol
20mg/hr continuous racemic albuterol
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High-dose nebulized albuterol is standard therapy for severe asthma exacerbations at The Children's Hospital of Philadelphia (CHOP) and other tertiary care pediatric hospitals throughout the United States. For the most severe exacerbations, albuterol is provided continuously at high doses until improvement is observed. This regimen has been standardized in a treatment protocol that has been used at CHOP for more than 5 years. Recently, levalbuterol (LEV), the purified active (R)-enantiomer of albuterol, has been approved for use in acute asthma. Preliminary evidence suggests that LEV may improve pulmonary function and clinical outcomes in children with asthma based on studies using standard dosing regimens. Laboratory and clinical evidence suggest that the (S)-enantiomer of albuterol may have detrimental effects that contribute to poor response to racemic albuterol (RAC). Limited data exist about the efficacy of LEV in high-dose regimens.
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of LEV compared to RAC when delivered continuously in a high-dose regimen for severe exacerbations of asthma. Children treated for asthma exacerbations in the CHOP emergency department (ED) will be eligible for study enrollment. Those that meet enrollment criteria will be randomized to receive either high dose RAC according to the standard asthma care protocol or equivalent dosing of LEV. Approximately 128 patients with 64 in each arm of the study will be enrolled. An interim safety analysis will be conducted after the first 40 patients are enrolled. This study should be completed in six to nine months. The primary outcome will be duration of continuous therapy. Secondary outcomes will include improvement of clinical asthma score and change in forced expiratory volume in one second (FEV1). In addition, (R)-albuterol and (S)-albuterol levels will be measured at study entry and at 6-hour intervals in the first 40 patients enrolled. These values will be used to determine prior RAC exposure and to determine serum levels of (R) and (S) albuterol during continuous therapy.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Joseph J Zorc, MD | Children's Hospital of Philadelphia |
Study ID Numbers: | #2004-12-4130 |
Study First Received: | July 25, 2005 |
Last Updated: | November 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00124176 |
Health Authority: | United States: Institutional Review Board |
Asthma Levalbuterol Albuterol Children |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Status Asthmaticus |
Albuterol Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
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 |