- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00667407
Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma
A Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Hoover, Alabama, United States
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Montgomery, Alabama, United States
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California
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Encinitas, California, United States
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Fresno, California, United States
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Oakland, California, United States
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Torrance, California, United States
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Colorado
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Colorado Springs, Colorado, United States
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Florida
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Tampa, Florida, United States
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Illinois
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Chicago, Illinois, United States
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Louisiana
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Metairie, Louisiana, United States
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Michigan
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Missouri
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Kansas City, Missouri, United States
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St. Louis, Missouri, United States
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New Jersey
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Red Bank, New Jersey, United States
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New York
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Brooklyn, New York, United States
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New Hyde Park, New York, United States
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Syracuse, New York, United States
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North Carolina
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Rocky Mount, North Carolina, United States
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Ohio
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Oregon
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Lake Oswego, Oregon, United States
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Medford, Oregon, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Texas
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Houston, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
- Subjects must have history of asthma for at least 6 months.
- Subjects must present to the emergency department (ED) or clinic with forced expiratory volume in one second (FEV1) of 20 to 55% (inclusive) predicted at baseline
- Subjects must have O2 saturation greater than or equal to 90% at room air or with no more than 6 Liters/minute supplemental oxygen and no other cause of wheezing or shortness of breath other than asthma as determined by the physician.
- Prior use of a beta-agonist (e.g., Primatine Mist, albuterol, salmeterol, etc.) within 24 hours of presentation to the ED or Clinic.
- Smoked ≤ 10 pack-years or non-smoker.
- Be in good health with the exception of asthma and not suffering from any chronic condition which might affect their lung function, such as COPD or emphysema.
- Near-normal activity level between exacerbations.
- Subjects who are taking inhaled or systemic corticosteroids must be on a stable dose for at least 21 days prior to study entry.
Exclusion Criteria:
- Subjects who have received treatment for asthma in an ED, Clinic, or Urgent Care Center within 2 weeks prior to study entry.
- Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema.
- Subjects with a history of asthma episodes associated with hypercapnia, respiratory arrest, hypoxic seizures, or requiring intubation within 12 months prior to entry.
- Hospitalization for asthma within two months prior to entry.
- Female subjects who are pregnant or lactating.
- Subjects who have a history of a clinically significant psychiatric disorder within the last 3 months, with the exception of mild depression.
- Subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Levalbuterol 1.25 mg
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levalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated. Period II: TID for 3 days (same time of day), then PRN to TID for 7 days
Other Names:
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Active Comparator: 2
Racemic Albuterol 2.5 mg
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Racemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated. Period II: TID for 3 days then PRN to TID for 7 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I.
Time Frame: 24 hours
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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FEV1 (Period I): Serial spirometry, maximum FEV1, time to maximum FEV1, baseline FEV1 severity on subject response; % responders, no. nebulizations to meet discharge criteria, rate of hospitalization, time to admit decision, rate for increased care
Time Frame: Day 0 (5-10 min after every dose)
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Day 0 (5-10 min after every dose)
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FEV1 (Period II): Spirometry, average FEV1; distribution of subject responses; rate of relapse; blinded study medication; length of stay in ED or Clinic during Period I; length of hospitalization, cost of care
Time Frame: Days 3, 10
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Days 3, 10
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Investigator and subject global evaluations, subject preference
Time Frame: Days 3, 10
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Days 3, 10
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Subject reported beta-mediated side effects
Time Frame: Days 3, 10
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Days 3, 10
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Pharmaceutical Solutions
- Albuterol
Other Study ID Numbers
- 051-915
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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