The purpose of this study is to determine the long-term safety of (R,R)-formoterol over a period of 12 months in subjects with COPD

Condition	Treatment or Intervention	Phase
Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema	Drug: (R,R)-formoterol	Phase III

Ages Eligible for Study:  35 Years and above,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA: In order to qualify for participation, subjects must meet the following criteria:

• Must give written informed consent prior to participation. Women of childbearing potential 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 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: In order to qualify for participation, subjects must not meet any of the following criteria:

• Currently using disallowed medications or will be unable to complete the medication washout periods
• 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

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

Study ID Numbers:  091-060
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00064415
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08