Phase
Condition
Emphysema
Bronchitis
Chronic Bronchitis
Treatment
N/AClinical Study ID
Ages > 35 All Genders
Study Summary
Eligibility Criteria
Inclusion
INCLUSION CRITERIA: In order to qualify for participation, subjects must meet the followingcriteria:
Must give written informed consent prior to participation. Women of childbearingpotential must also sign the Women of Childbearing Potential Addendum.
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 1and confirmed negative prior to randomization. Subjects of childbearing potential mustbe 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 bronchitisand/or emphysema. Diagnosis can be made during the screening process.
Have a minimum smoking history of 15 pack-years (pack-years = the number of cigarettepacks 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 torandomization
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 monthsprior to Visit 1. If there is no chest x-ray taken 3 months prior to Visit 1, a chestx-ray will be performed prior to Visit 2.
Be able to complete all study questionnaires and logs reliably
Exclusion
EXCLUSION CRITERIA: In order to qualify for participation, subjects must not meet any ofthe following criteria:
Currently using disallowed medications or will be unable to complete the medicationwashout periods
Female subject who is pregnant or lactating
Have participated in an investigational drug study within 30 days prior to Visit 1 orwho 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 lowerrespiratory tract infection, within the previous 30 days prior to Visit 1
Known history of asthma or any chronic respiratory disease (including a currenthistory 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 withsuccessful 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 supplementaloxygen, not to exceed 2 L/minute, at nighttime only and/or only during exercise isallowed.
Have had a change in dose or type of any medications for COPD within 14 days prior tothe screening visit
Have a known sensitivity to (R,R)-formoterol, ipratropium, salmeterol or albuterol orany of the excipients contained in any of these formulations
Have clinically significant abnormalities that may interfere with the metabolism orexcretion of the study drug
Have a history of substance abuse or drug abuse within 12 months of Visit 1 or with apositive 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 thesubject's ability to complete the study
Subject using any prescription drug for which concomitant beta-agonist administrationis contraindicated
Study Design
Study Description
Connect with a study center
Pinnacle Research Group
Anniston, Alabama 36207
United StatesSite Not Available
Princeton Pulmonary Group, PC
Birmingham, Alabama 35211
United StatesSite Not Available
Pulmonary & Sleep Associates of Jasper, PC
Jasper, Alabama 35501
United StatesSite Not Available
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama 36608
United StatesSite Not Available
Arizona Clinical Research Center, Inc.
Tucson, Arizona 85712
United StatesSite Not Available
Northern California Research Corp.
Fair Oaks, California 95628
United StatesSite Not Available
SARC Research Center
Fresno, California 93720
United StatesSite Not Available
Irvine Center for Clinical Research
Irvine, California 92618
United StatesSite Not Available
Scripps Clinic - Chest and Critical Care
LaJolla, California 92037
United StatesSite Not Available
Torrance Clinical Research
Los Angeles, California 90505
United StatesSite Not Available
Facey Medical Center - Radiant Research
Mission Hills, California 91345
United StatesSite Not Available
Office of Delmer Henninger, MD
Murrieta, California 92562
United StatesSite Not Available
Advanced Clinical Research Institute
Orange, California
United StatesSite Not Available
Center for Clinical Trials, LLC
Paramount, California 90723
United StatesSite Not Available
Advances in Medicine
Rancho Mirage, California 92270
United StatesSite Not Available
Inland Clinical Research, Inc.
Riverside, California 92501
United StatesSite Not Available
Institute of Healthcare Assessment, Inc.
San Diego, California 92120
United StatesSite Not Available
Wetlin Research Associates, Inc.
San Diego, California 92120
United StatesSite Not Available
San Jose Clinical Research, Inc.
San Jose, California 95128
United StatesSite Not Available
West Coast Clinical Trials
Signal Hill, California 90755
United StatesSite Not Available
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California 94598
United StatesSite Not Available
Northern Colorado Pulmonary Consultants, PC
Ft. Collins, Colorado 80528
United StatesSite Not Available
Clinical Research of West Florida, Inc.
Clearwater, Florida 33765
United StatesSite Not Available
University Clinical Research, DeLand
DeLand, Florida 32720
United StatesSite Not Available
nTouch Research
Melbourne, Florida 32901
United StatesSite Not Available
nTouch Research
St. Petersburg, Florida 33710
United StatesSite Not Available
AHS Medical Research, Inc.
Tampa, Florida 33615
United StatesSite Not Available
USF Asthma, Allergy and Immunology
Tampa, Florida 33613
United StatesSite Not Available
New Horizon Health Research
Atlanta, Georgia
United StatesSite Not Available
Protocare Trial, Inc.
Austell, Georgia 30106
United StatesSite Not Available
nTouch Research
Decatur, Georgia 30033
United StatesSite Not Available
Marietta Pulmonary Medicine
Marietta, Georgia 30060
United StatesSite Not Available
North Point Pulmonary Associates
Roswell, Georgia 30076
United StatesSite Not Available
Pulmonary Consultants
Coeur d'Alene, Idaho 83814
United StatesSite Not Available
University of Chicago - Department of Medicine
Chicago, Illinois 60637
United StatesSite Not Available
Sneeze, Wheeze and Itch, LLC
Normal, Illinois 61761
United StatesSite Not Available
Medisphere Medical Research Center, LLC
Evansville, Indiana 47714
United StatesSite Not Available
South Bend Clinic
South Bend, Indiana 46617
United StatesSite Not Available
Heart of America Research Institute
Shawnee Mission, Kansas 66216
United StatesSite Not Available
Bendel Medical Associates
Lafayette, Louisiana 70503
United StatesSite Not Available
New Orleans Center for Clinical Research
New Orleans, Louisiana 70119
United StatesSite Not Available
North Shore Research Associates
Slidell, Louisiana 70461
United StatesSite Not Available
Office of Paul A. Shapero, MD, PA
Bangor, Maine 04401
United StatesSite Not Available
Primary Care Cardiology Research, Inc.
Ayer, Massachusetts 01432
United StatesSite Not Available
Center for Clinical Research
Taunton, Massachusetts 02780
United StatesSite Not Available
ClinSite, Inc.
Ann Arbor, Michigan 48106
United StatesSite Not Available
Minnesota Lung Center
Minneapolis, Minnesota 55407
United StatesSite Not Available
MedEx HealthCare Research, Inc.
Saint Louis, Missouri 63108
United StatesSite Not Available
Midwest Chest Consultants, PC
St. Charles, Missouri 63301-2847
United StatesSite Not Available
C.A.R.E Clinical Research
St. Louis,, Missouri 63122
United StatesSite Not Available
Office of Keith Popovich, MD
Butte, Montana 59701
United StatesSite Not Available
Montana Medical Research, LLC
Missoula, Montana 59804
United StatesSite Not Available
Advanced Biomedical Research of America
Las Vegas, Nevada 89119
United StatesSite Not Available
Clinical Research Center of Nevada
Las Vegas, Nevada 89104
United StatesSite Not Available
Atlantic Research Associates, Inc.
Margate City, New Jersey 08402
United StatesSite Not Available
UrgentMed Family Practice Medical
South Bound Brook, New Jersey 08880
United StatesSite Not Available
Lovelace Scientific Resources - NM
Albuquerque, New Mexico 87108
United StatesSite Not Available
Endwell Family Physicians
Endwell, New York 13760
United StatesSite Not Available
Asthma & Allergy Associates, PC
Ithaca, New York 14850
United StatesSite Not Available
N.Y. Pulmonary Associates
New York City, New York 10016
United StatesSite Not Available
Ridgewood Medical Group
Rochester, New York 14626
United StatesSite Not Available
Charlotte Lung and Health Center
Charlotte, North Carolina 28207
United StatesSite Not Available
North Carolina Clinical Research
Raleigh, North Carolina
United StatesSite Not Available
New Hanover Medical Research
Wilmington, North Carolina 28412
United StatesSite Not Available
Odyssey Research Services
Fargo, North Dakota 58104
United StatesSite Not Available
Community Research Management Associates, Inc.
Cincinnati, Ohio 45219
United StatesSite Not Available
New Horizons Clinical Research, Inc.
Cincinnati, Ohio 45241
United StatesSite Not Available
COR Clinical Research LLC
Oklahoma City, Oklahoma 73103
United StatesSite Not Available
Healthcare Research Consultants
Tulsa, Oklahoma 74135
United StatesSite Not Available
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon 97504
United StatesSite Not Available
Medford Medical Clinic, LLP
Medford, Oregon 97504
United StatesSite Not Available
Allergy Associates Research Center
Portland, Oregon 97213
United StatesSite Not Available
Northeast Clinical Research Center, Inc.
Allentown, Pennsylvania 18104
United StatesSite Not Available
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Consortium Clinical Research, Ltd.
Ridley Park, Pennsylvania 19078
United StatesSite Not Available
Safe Harbor Clinical Research
East Providence, Rhode Island 02914
United StatesSite Not Available
Spartanburg Pharmaceutical Research
Spartanburg, South Carolina 29307
United StatesSite Not Available
Volunteer Research Group
Knoxville, Tennessee 37920
United StatesSite Not Available
Ben Taub General Hospital
Houston, Texas 77030
United StatesSite Not Available
Breath of Life Research Institute
Houston, Texas 77084
United StatesSite Not Available
S.W. Asthma Institute
Houston, Texas 77074
United StatesSite Not Available
Wellmed at Northern Hills
San Antonio, Texas 78217
United StatesSite Not Available
Medsource, Inc.
Chesapeake, Virginia 23321
United StatesSite Not Available
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia 22401
United StatesSite Not Available
Commonwealth Clinical Research
Richmond, Virginia 23226
United StatesSite Not Available
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia 23225
United StatesSite Not Available
Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
Richmond, Virginia 23229
United StatesSite Not Available
Pulmonary Research Partners, Inc.
South Boston, Virginia 24592
United StatesSite Not Available
Pulmonary Consultants, PLLC
Tacoma, Washington 98405
United StatesSite Not Available
Morgantown Pulmonary Associates
Morgantown, West Virginia 26505
United StatesSite Not Available
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