The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of (R,R)-formoterol administered for 12 weeks as maintenance treatment in patients 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.
• Be willing to comply with study procedures and visit schedule
• 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. Women taking hormone replacement therapy may have a FSH level of >30 IU/L
• 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).
• Medical Research Council (MRC) Dyspnea Scale Score .2
• Have a baseline FEV1 <65% of predicted normal value and >0.70 L documented at two of three visits prior to randomization
• Have an FEV1/forced vital capacity (FVC) ratio <70% documented at two of three visits prior to randomization
• Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months prior to Visit 1
• 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:

• Subject who is 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
• 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 a blood eosinophil count >5% of total white blood cell count
• 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. The use of supplemental oxygen, not to exceed 2L/minute, at nighttime only and/or only during exercise is allowed.
• 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 (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, or with a positive urine drug screen
• Have a clinically significant abnormal laboratory value
• Have a clinically significant abnormal 12-lead ECG that may jeopardize the subject’s ability to complete the study
• Are using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers)

Alabama
      Pulmonary & Sleep Associates of Jasper, PC, Jasper,  Alabama,  35501,  United States
Arizona
      Arizona Clinical Research Center, Inc., Tucson,  Arizona,  85712,  United States
      Pulmonary Associates, PA, Phoenix,  Arizona,  85006,  United States
California
      Institute of Healthcare Assessment, Inc., San Diego,  California,  92120,  United States
      Center for Clinical Trials, LLC, Paramount,  California,  90723,  United States
      Advances in Medicine, Rancho Mirage,  California,  92270,  United States
      Radiant Research-Irvine, Irvine,  California,  92618,  United States
      California Research Medical Group, Inc., Fullerton,  California,  92835,  United States
      Allergy & Asthma Medical Group of Diablo Valley, Inc., Walnut Creek,  California,  94598,  United States
      SARC Research Center, Fresno,  California,  93720,  United States
      Northern California Research Corp., Fair Oaks,  California,  95628,  United States
      West Coast Clinical Trials, Newport Beach,  California,  United States
      San Jose Clinical Research, San Jose,  California,  United States
Colorado
      Colorado Pulmonary Associates, Denver,  Colorado,  80218,  United States
      Northern Colorado Pulmonary Consultants, PC, Fort Collins,  Colorado,  United States
Connecticut
      Physicians Research Center, Inc., Hartford,  Connecticut,  06106,  United States
District of Columbia
      Washington Hospital Center, Washington,  District of Columbia,  United States
Florida
      Mt. Sinai Medical Center, Miami Beach,  Florida,  33140,  United States
      Clinical Pharmacology Services, Tampa,  Florida,  33617,  United States
      University Clinical Research, DeLand, Deland,  Florida,  32720,  United States
      Clinical Research of West Florida, Inc., Clearwater,  Florida,  33765,  United States
Georgia
      Marietta Pulmonary Medicine, Marietta,  Georgia,  30060,  United States
      Protocare Trial, Inc., Austell,  Georgia,  30106,  United States
Illinois
      Office of Bradley Sakran, MD, PC, O Fallon,  Illinois,  62269,  United States
Indiana
      South Bend Clinic, South Bend,  Indiana,  46617,  United States
Kentucky
      Family Allergy & Asthma Research Institute, Louisville,  Kentucky,  40215,  United States
      Cumberland Lung and Sleep Specialists, Somerset,  Kentucky,  United States
Louisiana
      North Shore Research Associates, Slidell,  Louisiana,  70461,  United States
      Bendel Medical Associates/Research, Lafayette,  Louisiana,  70503,  United States
      Best Clinical Trials, LLC, New Orleans,  Louisiana,  70115,  United States
      Sunset Medical Research, Sunset,  Louisiana,  70584,  United States
      New Orleans Center for Clinical Research, New Orleans,  Louisiana,  70119,  United States
      New Orleans Center for Clinical Research, New Orleans,  Louisiana,  United States
Maryland
      University of Maryland-Airways Research Center, Baltimore,  Maryland,  United States
      Institute of Asthma and Allergy, Wheaton,  Maryland,  United States
Massachusetts
      Pro-Medica Clinical Research Center, Boston,  Massachusetts,  02135,  United States
Michigan
      ClinSite, Inc., Ann Arbor,  Michigan,  48106,  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,  United States
      Montana Medical Research, LLC, Missoula,  Montana,  United States
Nebraska
      VA Medical Center, Omaha,  Nebraska,  United States
Nevada
      Advanced Biomedical Research of America, Las Vegas,  Nevada,  89119,  United States
North Carolina
      Carolina Pharmaceutical Research, Inc., Statesville,  North Carolina,  28625,  United States
      Pulmonary Medicine, Chapel Hill,  North Carolina,  27599,  United States
      New Hanover Medical Research, Wilmington,  North Carolina,  28412,  United States
      Charlotte Lung and Health Center, Charlotte,  North Carolina,  28207,  United States
Ohio
      New Horizons Clinical Research, Inc., Cincinnati,  Ohio,  45241,  United States
Oklahoma
      COR Clinical Research LLC, Oklahoma City,  Oklahoma,  73103,  United States
Oregon
      Allergy Associates Research Center, Portland,  Oregon,  97213,  United States
Pennsylvania
      Northeast Clinical Research Centers, Inc., Allentown,  Pennsylvania,  18104,  United States
      Keystone Clinical Solutions, Altoona,  Pennsylvania,  16602,  United States
      Philadelphia Health Associates - Adult Medicine, Philadelphia,  Pennsylvania,  19146,  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
      Central Texas Health Research, New Braunfels,  Texas,  78130,  United States
      Sylvana Research Associates, San Antonio,  Texas,  78229,  United States
Virginia
      Pulmonary Associates of Richmond, Inc., Richmond,  Virginia,  23225,  United States
      Pulmonary Associates of Fredericksburg, Inc., Fredericksburg,  Virginia,  22401,  United States
Washington
      Bellingham Asthma, Allergy & Immunology Clinic, Bellingham,  Washington,  98225,  United States
Wisconsin
      University of Wisconsin-Medical School, Madison,  Wisconsin,  53792,  United States

Study ID Numbers:  091-051
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00064402
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08