Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD
NCT ID: NCT00064402
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
741 participants
INTERVENTIONAL
2002-04-30
2004-03-31
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
TRIPLE
Study Groups
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1
Arformoterol 50 mcg QD and placebo MDI
arformoterol tartrate inhalation solution
arformoterol 50 mcg QD
2
Arformoterol 25 mcg BID and Placebo MDI
arformoterol tartrate inhalation solution
arformoterol 25 mcg BID
3
Arformoterol 15 mcg BID and placebo MDI
arformoterol tartrate inhalation solution
arformoterol 15 mcg BID
4
Salmeterol MDI 42 mcg BID and placebo inhalation solution
Salmeterol
Salmeterol MDI 42 mcg BID
5
Placebo MDI and placebo inhalation solution
Placebo
Placebo BID
Interventions
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arformoterol tartrate inhalation solution
arformoterol 50 mcg QD
arformoterol tartrate inhalation solution
arformoterol 25 mcg BID
arformoterol tartrate inhalation solution
arformoterol 15 mcg BID
Salmeterol
Salmeterol MDI 42 mcg BID
Placebo
Placebo BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are at least 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: documented surgically sterile, OR postmenopausal.
* Have a primary diagnosis of COPD. 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).
* Have a chest x-ray that is consistent with the diagnosis of COPD and taken \<3 months prior to study start
* Able to complete all study questionnaires and logs reliably
Exclusion Criteria
* Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another investigational drug study
* Subject whose schedule or travel prevents the completion of all required visits
* Are scheduled for in-patient hospitalization, including elective surgery during the trial
* Have life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days
* History of asthma or any chronic respiratory disease other than COPD (chronic bronchitis and/or emphysema)
* Have clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
* Have a history of cancer except non-melanomatous skin cancer
* Have a history of lung resection of more than one full lobe
* Requires continuous supplemental oxygen therapy.
* Has 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 arformoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations
* Have a history of substance abuse or drug abuse within 12 months, or with a positive urine drug screen
* Are using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers)
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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Pulmonary & Sleep Associates of Jasper, PC
Jasper, Alabama, United States
Pulmonary Associates, PA
Phoenix, Arizona, 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
California Research Medical Group, Inc.
Fullerton, California, United States
Radiant Research-Irvine
Irvine, California, United States
West Coast Clinical Trials
Newport Beach, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Advances in Medicine
Rancho Mirage, California, United States
Institute of Healthcare Assessment, Inc.
San Diego, California, United States
San Jose Clinical Research
San Jose, California, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California, United States
Colorado Pulmonary Associates
Denver, Colorado, United States
Northern Colorado Pulmonary Consultants, PC
Fort Collins, Colorado, United States
Physicians Research Center, Inc.
Hartford, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
University Clinical Research, DeLand
DeLand, Florida, United States
Mt. Sinai Medical Center
Miami Beach, Florida, United States
Clinical Pharmacology Services
Tampa, Florida, United States
Protocare Trial, Inc.
Austell, Georgia, United States
Marietta Pulmonary Medicine
Marietta, Georgia, United States
Office of Bradley Sakran, MD, PC
O'Fallon, Illinois, United States
South Bend Clinic
South Bend, Indiana, United States
Family Allergy & Asthma Research Institute
Louisville, Kentucky, United States
Cumberland Lung and Sleep Specialists
Somerset, Kentucky, United States
Bendel Medical Associates/Research
Lafayette, Louisiana, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
North Shore Research Associates
Slidell, Louisiana, United States
Sunset Medical Research
Sunset, Louisiana, United States
University of Maryland-Airways Research Center
Baltimore, Maryland, United States
Institute of Asthma and Allergy
Wheaton, Maryland, United States
Pro-Medica Clinical Research Center
Boston, Massachusetts, United States
ClinSite, Inc.
Ann Arbor, Michigan, 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
VA Medical Center
Omaha, Nebraska, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Pulmonary Medicine
Chapel Hill, North Carolina, United States
Charlotte Lung and Health Center
Charlotte, North Carolina, United States
Carolina Pharmaceutical Research, Inc.
Statesville, North Carolina, United States
New Hanover Medical Research
Wilmington, North Carolina, United States
New Horizons Clinical Research, Inc.
Cincinnati, Ohio, United States
COR Clinical Research LLC
Oklahoma City, Oklahoma, United States
Allergy Associates Research Center
Portland, Oregon, United States
Northeast Clinical Research Centers, Inc.
Allentown, Pennsylvania, United States
Keystone Clinical Solutions
Altoona, Pennsylvania, United States
Philadelphia Health Associates - Adult Medicine
Philadelphia, 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
Breath of Life Research Institute
Houston, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington, United States
University of Wisconsin-Medical School
Madison, Wisconsin, United States
Countries
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Other Identifiers
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091-051
Identifier Type: -
Identifier Source: org_study_id
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