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| Sponsor: | Sunovion |
|---|---|
| Information provided by: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00064415 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
Arformoterol tartrate 50 mcg QD
|
Drug: arformoterol
Arformoterol inhalation solution, 50 mcg QD
Other Names:
|
|
Active Comparator: 2
Salmeterol 42 mcg BID
|
Drug: Salmeterol
Salmeterol MDI, 42 mcg BID
Other Names:
|
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. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Eligibility| 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:
Contacts and Locations
Show 90 Study Locations
More Information
| Responsible Party: | Arformoterol Medical Director, Sunovion Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00064415 History of Changes |
| Other Study ID Numbers: | 091-060 |
| Study First Received: | July 8, 2003 |
| Last Updated: | November 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Bronchitis Bronchitis, Chronic Emphysema Pulmonary Emphysema Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchial Diseases Respiratory Tract Diseases Respiratory Tract Infections Pathologic Processes Formoterol Salmeterol |
Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |