To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD
NCT ID: NCT00064415
Last Updated: 2012-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
799 participants
INTERVENTIONAL
2002-06-30
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Arformoterol tartrate 50 mcg QD
arformoterol
Arformoterol inhalation solution, 50 mcg QD
2
Salmeterol 42 mcg BID
Salmeterol
Salmeterol MDI, 42 mcg BID
Interventions
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arformoterol
Arformoterol inhalation solution, 50 mcg QD
Salmeterol
Salmeterol MDI, 42 mcg BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be willing to comply with study procedures and visit schedule
* Male or female \>35 years of age
* Female subjects \<65 years of age must have a serum pregnancy test conducted at Visit 1 and confirmed negative prior to randomization. Subjects of childbearing potential must be using an acceptable method of birth control.
* Female subjects who are considered not of childbearing potential must be: (1) documented surgically sterile, OR (2) postmenopausal
* Have a primary diagnosis of COPD, which may include components of chronic bronchitis and/or emphysema. Diagnosis can be made during the screening process.
* Have a minimum smoking history of 15 pack-years (pack-years = the number of cigarette packs per day times the number of years)
* Medical Research Council (MRC) Dyspnea Scale Score \>2
* Have a baseline FEV1 \<65% of predicted normal value and \>0.70 L documented prior to randomization
* Have an FEV1/FVC ratio \<70% documented prior to randomization.
* Have a chest x-ray that is consistent with the diagnosis of COPD and taken \<3 months prior to Visit 1. If there is no chest x-ray taken 3 months prior to Visit 1, a chest x-ray will be performed prior to Visit 2.
* Be able to complete all study questionnaires and logs reliably
Exclusion Criteria
* Female subject who is pregnant or lactating
* Have participated in an investigational drug study within 30 days prior to Visit 1 or who is currently participating in another investigational drug study
* Subject whose schedule or travel prevents the completion of all required visits
* Subject who is scheduled for in-patient hospitalization, including elective surgery (in-patient or out-patient) during the trial.
* Subject with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit 1
* Known history of asthma or any chronic respiratory disease (including a current history of sleep apnea) other than COPD (chronic bronchitis and/or emphysema).
* Subject with a blood eosinophil count \>5%
* Subject with clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
* History of cancer except non-melanomatous skin cancer
* History of lung resection of more than one full lobe
* Subject who requires continuous supplemental oxygen therapy. The use of supplemental oxygen, not to exceed 2 L/minute, at nighttime only and/or only during exercise is allowed.
* Have had a change in dose or type of any medications for COPD within 14 days prior to the screening visit
* Have a known sensitivity to (R,R)-formoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations
* Have clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug
* Have a history of substance abuse or drug abuse within 12 months of Visit 1 or with a positive urine drug screen at the screening visit
* Subject with clinically significant abnormal laboratory values
* Subject with clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete the study
* Subject using any prescription drug for which concomitant beta-agonist administration is contraindicated
35 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Locations
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Pinnacle Research Group
Anniston, Alabama, United States
Princeton Pulmonary Group, PC
Birmingham, Alabama, United States
Pulmonary & Sleep Associates of Jasper, PC
Jasper, Alabama, United States
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, United States
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Northern California Research Corp.
Fair Oaks, California, United States
SARC Research Center
Fresno, California, United States
Irvine Center for Clinical Research
Irvine, California, United States
Scripps Clinic - Chest and Critical Care
La Jolla, California, United States
Torrance Clinical Research
Los Angeles, California, United States
Facey Medical Center - Radiant Research
Mission Hills, California, United States
Office of Delmer Henninger, MD
Murrieta, California, United States
Advanced Clinical Research Institute
Orange, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Advances in Medicine
Rancho Mirage, California, United States
Inland Clinical Research, Inc.
Riverside, California, United States
Institute of Healthcare Assessment, Inc.
San Diego, California, United States
Wetlin Research Associates, Inc.
San Diego, California, United States
San Jose Clinical Research, Inc.
San Jose, California, United States
West Coast Clinical Trials
Signal Hill, California, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California, United States
Northern Colorado Pulmonary Consultants, PC
Fort Collins, Colorado, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
University Clinical Research, DeLand
DeLand, Florida, United States
nTouch Research
Melbourne, Florida, United States
nTouch Research
St. Petersburg, Florida, United States
USF Asthma, Allergy and Immunology
Tampa, Florida, United States
AHS Medical Research, Inc.
Tampa, Florida, United States
New Horizon Health Research
Atlanta, Georgia, United States
Protocare Trial, Inc.
Austell, Georgia, United States
nTouch Research
Decatur, Georgia, United States
Marietta Pulmonary Medicine
Marietta, Georgia, United States
North Point Pulmonary Associates
Roswell, Georgia, United States
Pulmonary Consultants
Coeur d'Alene, Idaho, United States
University of Chicago - Department of Medicine
Chicago, Illinois, 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
Heart of America Research Institute
Shawnee Mission, Kansas, United States
Bendel Medical Associates
Lafayette, Louisiana, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
North Shore Research Associates
Slidell, Louisiana, United States
Office of Paul A. Shapero, MD, PA
Bangor, Maine, United States
Primary Care Cardiology Research, Inc.
Ayer, Massachusetts, United States
Center for Clinical Research
Taunton, Massachusetts, United States
ClinSite, Inc.
Ann Arbor, Michigan, United States
Minnesota Lung Center
Minneapolis, Minnesota, United States
Midwest Chest Consultants, PC
Saint Charles, Missouri, United States
MedEx HealthCare Research, Inc.
St Louis, Missouri, United States
C.A.R.E Clinical Research
St Louis, Missouri, United States
Office of Keith Popovich, MD
Butte, Montana, United States
Montana Medical Research, LLC
Missoula, Montana, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Atlantic Research Associates, Inc.
Margate City, New Jersey, United States
UrgentMed Family Practice Medical
South Bound Brook, New Jersey, United States
Lovelace Scientific Resources - NM
Albuquerque, New Mexico, United States
Endwell Family Physicians
Endwell, New York, United States
Asthma & Allergy Associates, PC
Ithaca, New York, United States
N.Y. Pulmonary Associates
New York, New York, United States
Ridgewood Medical Group
Rochester, New York, United States
Charlotte Lung and Health Center
Charlotte, North Carolina, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
New Hanover Medical Research
Wilmington, North Carolina, United States
Odyssey Research Services
Fargo, North Dakota, United States
Community Research Management Associates, Inc.
Cincinnati, Ohio, United States
New Horizons Clinical Research, Inc.
Cincinnati, Ohio, United States
COR Clinical Research LLC
Oklahoma City, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Medford Medical Clinic, LLP
Medford, Oregon, United States
Allergy Associates Research Center
Portland, Oregon, United States
Northeast Clinical Research Center, Inc.
Allentown, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Consortium Clinical Research, Ltd.
Ridley Park, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Spartanburg Pharmaceutical Research
Spartanburg, South Carolina, United States
Volunteer Research Group
Knoxville, Tennessee, 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
Wellmed at Northern Hills
San Antonio, Texas, United States
Medsource, Inc.
Chesapeake, Virginia, United States
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
Commonwealth Clinical Research
Richmond, Virginia, United States
Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
Richmond, Virginia, United States
Pulmonary Research Partners, Inc.
South Boston, Virginia, United States
Pulmonary Consultants, PLLC
Tacoma, Washington, United States
Morgantown Pulmonary Associates
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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091-060
Identifier Type: -
Identifier Source: org_study_id
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