To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD
- Conditions
- Chronic Obstructive Pulmonary DiseaseChronic BronchitisEmphysema
- Interventions
- Registration Number
- NCT00064415
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 799
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Salmeterol Salmeterol 42 mcg BID 1 arformoterol Arformoterol tartrate 50 mcg QD
- Primary Outcome Measures
Name Time Method Overall occurrence of adverse events Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
- Secondary Outcome Measures
Name Time Method Laboratory parameters Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ECG parameters Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 Vital signs Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 Physical examination findings Weeks -1, 53 Plasma arformoterol concentrations Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 24-hour holter monitoring parameters Weeks -1, 0, 13, 26, 39, 52
Trial Locations
- Locations (88)
Advances in Medicine
🇺🇸Rancho Mirage, California, United States
Inland Clinical Research, Inc.
🇺🇸Riverside, California, United States
New Horizon Health Research
🇺🇸Atlanta, Georgia, United States
University of Chicago - Department of Medicine
🇺🇸Chicago, Illinois, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Northern California Research Corp.
🇺🇸Fair Oaks, California, United States
Pulmonary Associates of Mobile, P.C.
🇺🇸Mobile, Alabama, United States
Torrance Clinical Research
🇺🇸Los Angeles, California, United States
Facey Medical Center - Radiant Research
🇺🇸Mission Hills, California, United States
Safe Harbor Clinical Research
🇺🇸East Providence, Rhode Island, United States
Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Office of Paul A. Shapero, MD, PA
🇺🇸Bangor, Maine, United States
North Shore Research Associates
🇺🇸Slidell, Louisiana, United States
Center for Clinical Research
🇺🇸Taunton, Massachusetts, United States
Pulmonary Consultants
🇺🇸Coeur d'Alene, Idaho, United States
Bendel Medical Associates
🇺🇸Lafayette, Louisiana, United States
Office of Keith Popovich, MD
🇺🇸Butte, Montana, United States
Atlantic Research Associates, Inc.
🇺🇸Margate City, New Jersey, United States
Montana Medical Research, LLC
🇺🇸Missoula, Montana, United States
UrgentMed Family Practice Medical
🇺🇸South Bound Brook, New Jersey, United States
Spartanburg Pharmaceutical Research
🇺🇸Spartanburg, South Carolina, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
S.W. Asthma Institute
🇺🇸Houston, Texas, United States
Breath of Life Research Institute
🇺🇸Houston, Texas, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Advanced Biomedical Research of America
🇺🇸Las Vegas, Nevada, United States
Institute of Healthcare Assessment, Inc.
🇺🇸San Diego, California, United States
Wetlin Research Associates, Inc.
🇺🇸San Diego, California, United States
Minnesota Lung Center
🇺🇸Minneapolis, Minnesota, United States
Community Research Management Associates, Inc.
🇺🇸Cincinnati, Ohio, United States
Wellmed at Northern Hills
🇺🇸San Antonio, Texas, United States
Odyssey Research Services
🇺🇸Fargo, North Dakota, United States
Heart of America Research Institute
🇺🇸Shawnee Mission, Kansas, United States
Princeton Pulmonary Group, PC
🇺🇸Birmingham, Alabama, United States
COR Clinical Research LLC
🇺🇸Oklahoma City, Oklahoma, United States
Allergy Associates Research Center
🇺🇸Portland, Oregon, United States
USF Asthma, Allergy and Immunology
🇺🇸Tampa, Florida, United States
West Coast Clinical Trials
🇺🇸Signal Hill, California, United States
Pulmonary & Sleep Associates of Jasper, PC
🇺🇸Jasper, Alabama, United States
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
SARC Research Center
🇺🇸Fresno, California, United States
Irvine Center for Clinical Research
🇺🇸Irvine, California, United States
Scripps Clinic - Chest and Critical Care
🇺🇸LaJolla, California, United States
Advanced Clinical Research Institute
🇺🇸Orange, California, United States
Office of Delmer Henninger, MD
🇺🇸Murrieta, California, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
San Jose Clinical Research, Inc.
🇺🇸San Jose, California, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
🇺🇸Walnut Creek, California, United States
Northern Colorado Pulmonary Consultants, PC
🇺🇸Ft. Collins, Colorado, United States
University Clinical Research, DeLand
🇺🇸DeLand, Florida, United States
nTouch Research
🇺🇸Decatur, Georgia, United States
Protocare Trial, Inc.
🇺🇸Austell, Georgia, United States
Marietta Pulmonary Medicine
🇺🇸Marietta, Georgia, United States
Sneeze, Wheeze and Itch, LLC
🇺🇸Normal, Illinois, United States
Medisphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
North Point Pulmonary Associates
🇺🇸Roswell, Georgia, United States
Primary Care Cardiology Research, Inc.
🇺🇸Ayer, Massachusetts, United States
Midwest Chest Consultants, PC
🇺🇸St. Charles, Missouri, United States
C.A.R.E Clinical Research
🇺🇸St. Louis,, Missouri, United States
MedEx HealthCare Research, Inc.
🇺🇸Saint Louis, Missouri, United States
Lovelace Scientific Resources - NM
🇺🇸Albuquerque, New Mexico, United States
Endwell Family Physicians
🇺🇸Endwell, New York, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Asthma & Allergy Associates, PC
🇺🇸Ithaca, New York, United States
Ridgewood Medical Group
🇺🇸Rochester, New York, United States
Charlotte Lung and Health Center
🇺🇸Charlotte, North Carolina, United States
New Hanover Medical Research
🇺🇸Wilmington, North Carolina, United States
N.Y. Pulmonary Associates
🇺🇸New York City, New York, United States
Medford Medical Clinic, LLP
🇺🇸Medford, Oregon, United States
New Horizons Clinical Research, Inc.
🇺🇸Cincinnati, Ohio, United States
Healthcare Research Consultants
🇺🇸Tulsa, Oklahoma, United States
Clinical Research Institute of Southern Oregon, PC
🇺🇸Medford, Oregon, United States
Consortium Clinical Research, Ltd.
🇺🇸Ridley Park, Pennsylvania, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Pulmonary Associates of Fredericksburg, Inc.
🇺🇸Fredericksburg, Virginia, United States
Medsource, Inc.
🇺🇸Chesapeake, Virginia, United States
Pulmonary Consultants, PLLC
🇺🇸Tacoma, Washington, United States
Pulmonary Research Partners, Inc.
🇺🇸South Boston, Virginia, United States
Morgantown Pulmonary Associates
🇺🇸Morgantown, West Virginia, United States
Northeast Clinical Research Center, Inc.
🇺🇸Allentown, Pennsylvania, United States
AHS Medical Research, Inc.
🇺🇸Tampa, Florida, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
ClinSite, Inc.
🇺🇸Ann Arbor, Michigan, United States
Pulmonary Associates of Richmond, Inc.
🇺🇸Richmond, Virginia, United States
Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
🇺🇸Richmond, Virginia, United States
Commonwealth Clinical Research
🇺🇸Richmond, Virginia, United States