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Sponsored by: |
Sepracor, Inc. |
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Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00665600 |
To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: Levalbuterol HCl Drug: Albuterol Sulfate Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease |
Enrollment: | 257 |
Study Start Date: | February 2002 |
Study Completion Date: | March 2003 |
Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Levalbuterol 0.63 mg TID
|
Drug: Levalbuterol HCl
Levalbuterol 0.63 TID
|
2: Experimental
Levalbuterol 1.25 mg TID
|
Drug: Levalbuterol HCl
Levabuterol 1.25 mg TID
|
3: Active Comparator
Racemic Albuterol 2.5 mg TID
|
Drug: Albuterol Sulfate
Racemic albuterol 2.5 mg TID
|
4: Placebo Comparator
Placebo TID
|
Drug: Placebo
Placebo TID
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This study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled to randomize at least 200 subjects. Study participation will consist of a total of six study visits over nine weeks for each subject.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sepracor ( Xopenex Medical Affairs Director ) |
Study ID Numbers: | 051-914 |
Study First Received: | April 22, 2008 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00665600 |
Health Authority: | United States: Food and Drug Administration |
COPD Chronic Bronchitis Chronic Emphysema |
Pulmonary Emphysema Emphysema Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Diseases |
Lung Diseases Albuterol Respiration Disorders Bronchitis Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Physiological Effects of Drugs Anti-Asthmatic Agents Reproductive Control Agents |
Pharmacologic Actions Adrenergic Agonists Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |