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| Sponsor: | Sepracor, Inc. |
|---|---|
| Information provided by: | Sepracor, Inc. |
| 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: | 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
|
Drug: arformoterol
Arformoterol inhalation solution, 50 mcg QD
|
|
2: Active Comparator
Salmeterol 42 mcg BID
|
Drug: Salmeterol
Salmeterol MDI, 42 mcg BID
|
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
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
Hide Study Locations| United States, Alabama | |
| Pulmonary & Sleep Associates of Jasper, PC | |
| Jasper, Alabama, United States, 35501 | |
| Pulmonary Associates of Mobile, P.C. | |
| Mobile, Alabama, United States, 36608 | |
| Princeton Pulmonary Group, PC | |
| Birmingham, Alabama, United States, 35211 | |
| Pinnacle Research Group | |
| Anniston, Alabama, United States, 36207 | |
| United States, Arizona | |
| Arizona Clinical Research Center, Inc. | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Institute of Healthcare Assessment, Inc. | |
| San Diego, California, United States, 92120 | |
| Advances in Medicine | |
| Rancho Mirage, California, United States, 92270 | |
| Allergy & Asthma Medical Group of Diablo Valley, Inc. | |
| Walnut Creek, California, United States, 94598 | |
| Northern California Research Corp. | |
| Fair Oaks, California, United States, 95628 | |
| SARC Research Center | |
| Fresno, California, United States, 93720 | |
| Center for Clinical Trials, LLC | |
| Paramount, California, United States, 90723 | |
| Scripps Clinic - Chest and Critical Care | |
| LaJolla, California, United States, 92037 | |
| Facey Medical Center - Radiant Research | |
| Mission Hills, California, United States, 91345 | |
| San Jose Clinical Research, Inc. | |
| San Jose, California, United States, 95128 | |
| Office of Delmer Henninger, MD | |
| Murrieta, California, United States, 92562 | |
| Irvine Center for Clinical Research | |
| Irvine, California, United States, 92618 | |
| West Coast Clinical Trials | |
| Signal Hill, California, United States, 90755 | |
| Wetlin Research Associates, Inc. | |
| San Diego, California, United States, 92120 | |
| Torrance Clinical Research | |
| Los Angeles, California, United States, 90505 | |
| Inland Clinical Research, Inc. | |
| Riverside, California, United States, 92501 | |
| Advanced Clinical Research Institute | |
| Orange, California, United States | |
| United States, Colorado | |
| Northern Colorado Pulmonary Consultants, PC | |
| Ft. Collins, Colorado, United States, 80528 | |
| United States, Florida | |
| Clinical Research of West Florida, Inc. | |
| Clearwater, Florida, United States, 33765 | |
| nTouch Research | |
| Melbourne, Florida, United States, 32901 | |
| USF Asthma, Allergy and Immunology | |
| Tampa, Florida, United States, 33613 | |
| AHS Medical Research, Inc. | |
| Tampa, Florida, United States, 33615 | |
| University Clinical Research, DeLand | |
| DeLand, Florida, United States, 32720 | |
| nTouch Research | |
| St. Petersburg, Florida, United States, 33710 | |
| United States, Georgia | |
| Marietta Pulmonary Medicine | |
| Marietta, Georgia, United States, 30060 | |
| Protocare Trial, Inc. | |
| Austell, Georgia, United States, 30106 | |
| North Point Pulmonary Associates | |
| Roswell, Georgia, United States, 30076 | |
| nTouch Research | |
| Decatur, Georgia, United States, 30033 | |
| New Horizon Health Research | |
| Atlanta, Georgia, United States | |
| United States, Idaho | |
| Pulmonary Consultants | |
| Coeur d'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Sneeze, Wheeze and Itch, LLC | |
| Normal, Illinois, United States, 61761 | |
| University of Chicago - Department of Medicine | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| South Bend Clinic | |
| South Bend, Indiana, United States, 46617 | |
| Medisphere Medical Research Center, LLC | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kansas | |
| Heart of America Research Institute | |
| Shawnee Mission, Kansas, United States, 66216 | |
| United States, Louisiana | |
| Bendel Medical Associates | |
| Lafayette, Louisiana, United States, 70503 | |
| North Shore Research Associates | |
| Slidell, Louisiana, United States, 70461 | |
| New Orleans Center for Clinical Research | |
| New Orleans, Louisiana, United States, 70119 | |
| United States, Maine | |
| Office of Paul A. Shapero, MD, PA | |
| Bangor, Maine, United States, 04401 | |
| United States, Massachusetts | |
| Primary Care Cardiology Research, Inc. | |
| Ayer, Massachusetts, United States, 01432 | |
| Center for Clinical Research | |
| Taunton, Massachusetts, United States, 02780 | |
| United States, Michigan | |
| ClinSite, Inc. | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| Minnesota Lung Center | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Missouri | |
| MedEx HealthCare Research, Inc. | |
| Saint Louis, Missouri, United States, 63108 | |
| C.A.R.E Clinical Research | |
| St. Louis,, Missouri, United States, 63122 | |
| Midwest Chest Consultants, PC | |
| St. Charles, Missouri, United States, 63301-2847 | |
| United States, Montana | |
| Office of Keith Popovich, MD | |
| Butte, Montana, United States, 59701 | |
| Montana Medical Research, LLC | |
| Missoula, Montana, United States, 59804 | |
| United States, Nevada | |
| Advanced Biomedical Research of America | |
| Las Vegas, Nevada, United States, 89119 | |
| Clinical Research Center of Nevada | |
| Las Vegas, Nevada, United States, 89104 | |
| United States, New Jersey | |
| Atlantic Research Associates, Inc. | |
| Margate City, New Jersey, United States, 08402 | |
| UrgentMed Family Practice Medical | |
| South Bound Brook, New Jersey, United States, 08880 | |
| United States, New Mexico | |
| Lovelace Scientific Resources - NM | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| Endwell Family Physicians | |
| Endwell, New York, United States, 13760 | |
| N.Y. Pulmonary Associates | |
| New York City, New York, United States, 10016 | |
| Ridgewood Medical Group | |
| Rochester, New York, United States, 14626 | |
| Asthma & Allergy Associates, PC | |
| Ithaca, New York, United States, 14850 | |
| United States, North Carolina | |
| Charlotte Lung and Health Center | |
| Charlotte, North Carolina, United States, 28207 | |
| New Hanover Medical Research | |
| Wilmington, North Carolina, United States, 28412 | |
| North Carolina Clinical Research | |
| Raleigh, North Carolina, United States | |
| United States, North Dakota | |
| Odyssey Research Services | |
| Fargo, North Dakota, United States, 58104 | |
| United States, Ohio | |
| New Horizons Clinical Research, Inc. | |
| Cincinnati, Ohio, United States, 45241 | |
| Community Research Management Associates, Inc. | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oklahoma | |
| COR Clinical Research LLC | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Healthcare Research Consultants | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Oregon | |
| Allergy Associates Research Center | |
| Portland, Oregon, United States, 97213 | |
| Medford Medical Clinic, LLP | |
| Medford, Oregon, United States, 97504 | |
| Clinical Research Institute of Southern Oregon, PC | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Northeast Clinical Research Center, Inc. | |
| Allentown, Pennsylvania, United States, 18104 | |
| Consortium Clinical Research, Ltd. | |
| Ridley Park, Pennsylvania, United States, 19078 | |
| United States, Rhode Island | |
| Safe Harbor Clinical Research | |
| East Providence, Rhode Island, United States, 02914 | |
| United States, South Carolina | |
| Spartanburg Pharmaceutical Research | |
| Spartanburg, South Carolina, United States, 29307 | |
| United States, Tennessee | |
| Volunteer Research Group | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Texas | |
| Breath of Life Research Institute | |
| Houston, Texas, United States, 77084 | |
| Ben Taub General Hospital | |
| Houston, Texas, United States, 77030 | |
| S.W. Asthma Institute | |
| Houston, Texas, United States, 77074 | |
| Wellmed at Northern Hills | |
| San Antonio, Texas, United States, 78217 | |
| United States, Virginia | |
| Pulmonary Associates of Fredericksburg, Inc. | |
| Fredericksburg, Virginia, United States, 22401 | |
| Pulmonary Associates of Richmond, Inc. | |
| Richmond, Virginia, United States, 23225 | |
| Virginia Adult & Pediatric Allergy & Asthma, PC Research Office | |
| Richmond, Virginia, United States, 23229 | |
| Commonwealth Clinical Research | |
| Richmond, Virginia, United States, 23226 | |
| Medsource, Inc. | |
| Chesapeake, Virginia, United States, 23321 | |
| Pulmonary Research Partners, Inc. | |
| South Boston, Virginia, United States, 24592 | |
| United States, Washington | |
| Pulmonary Consultants, PLLC | |
| Tacoma, Washington, United States, 98405 | |
| United States, West Virginia | |
| Morgantown Pulmonary Associates | |
| Morgantown, West Virginia, United States, 26505 | |
More Information
| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Pulmonary Emphysema Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Formoterol |
Bronchitis Emphysema Salmeterol Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Pharmacologic Actions Bronchitis, Chronic Autonomic Agents Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |