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Sponsored by: |
Sepracor, Inc. |
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Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00268723 |
To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be effective in the prevention of EIB and be safe and well-tolerated.
Condition | Intervention | Phase |
---|---|---|
Exercise-Induced Bronchospasm |
Drug: Levalbuterol tartrate HFA MDI Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study |
Official Title: | An Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Versus Placebo in Prevention of EIB in Subjects 18 Years of Age and Older With EIB |
Enrollment: | 15 |
Study Start Date: | December 2005 |
Study Completion Date: | February 2006 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
levalbuterol HFA MDI 90 mcg QID
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Drug: Levalbuterol tartrate HFA MDI
levalbuterol MDI 90 mcg QID
|
2: Placebo Comparator
Placebo MDI QID
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Drug: Placebo
Placebo MDI QID
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This was a randomized, double-blind, placebo-controlled, multicenter, two-way crossover study of levalbuterol tartrate HFA MDI in subjects 18 years of age and older with EIB.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Responsible Party: | Sepracor Inc. ( Xopenex Medical Affairs Director ) |
Study ID Numbers: | 051-925 |
Study First Received: | December 20, 2005 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00268723 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Spasm Neurotransmitter Agents Bronchial Spasm Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Albuterol Asthma Anti-Asthmatic Agents |
Adrenergic Agonists Asthma, Exercise-Induced Hypersensitivity Respiratory Tract Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Bronchial Spasm Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Albuterol Physiological Effects of Drugs Reproductive Control Agents Adrenergic Agonists Hypersensitivity Respiratory Tract Diseases Tocolytic Agents |
Therapeutic Uses Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Pharmacologic Actions Asthma, Exercise-Induced Autonomic Agents Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |