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Study 18 of 3601 for search of: | United States, Virginia |
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Sponsored by: |
Sepracor, Inc. |
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Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00064415 |
The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema |
Drug: arformoterol Drug: Salmeterol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Multicenter, Open-Label, Randomized, Active-Controlled, Parallel Group Chronic Safety Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease |
Enrollment: | 799 |
Study Start Date: | June 2002 |
Study Completion Date: | December 2004 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Arformoterol tartrate 50 mcg QD
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Drug: arformoterol
Arformoterol inhalation solution, 50 mcg QD
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2: Active Comparator
Salmeterol 42 mcg BID
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Drug: Salmeterol
Salmeterol MDI, 42 mcg BID
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This was a multicenter, open-label, randomized, active controlled, parallel group chronic safety study of arformoterol 50 mcg once daily over a period of 12 months in subjects with COPD
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA: In order to qualify for participation, subjects must meet the following criteria:
EXCLUSION CRITERIA: In order to qualify for participation, subjects must not meet any of the following criteria:
Responsible Party: | Sepracor ( Arformoterol Medical Director ) |
Study ID Numbers: | 091-060 |
Study First Received: | July 8, 2003 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00064415 |
Health Authority: | United States: Food and Drug Administration |
Pulmonary Emphysema Emphysema Bronchitis, Chronic Lung Diseases, Obstructive Salmeterol Respiratory Tract Infections |
Respiratory Tract Diseases Lung Diseases Respiration Disorders Formoterol Bronchitis Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Adrenergic Agonists Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |