To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD

Last updated: February 21, 2012
Sponsor: Sunovion
Overall Status: Completed

Phase

3

Condition

Emphysema

Bronchitis

Chronic Bronchitis

Treatment

N/A

Clinical Study ID

NCT00064415
091-060
  • Ages > 35
  • All Genders

Study Summary

The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD

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

Total Participants: 799
Study Start date:
June 01, 2002
Estimated Completion Date:
December 31, 2004

Study Description

This was a multicenter, open-label, randomized, active controlled, parallel group chronic safety study of arformoterol 50 mcg once daily over a period of 12 months in subjects with COPD. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Connect with a study center

  • Pinnacle Research Group

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Princeton Pulmonary Group, PC

    Birmingham, Alabama 35211
    United States

    Site Not Available

  • Pulmonary & Sleep Associates of Jasper, PC

    Jasper, Alabama 35501
    United States

    Site Not Available

  • Pulmonary Associates of Mobile, P.C.

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Arizona Clinical Research Center, Inc.

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Northern California Research Corp.

    Fair Oaks, California 95628
    United States

    Site Not Available

  • SARC Research Center

    Fresno, California 93720
    United States

    Site Not Available

  • Irvine Center for Clinical Research

    Irvine, California 92618
    United States

    Site Not Available

  • Scripps Clinic - Chest and Critical Care

    LaJolla, California 92037
    United States

    Site Not Available

  • Torrance Clinical Research

    Los Angeles, California 90505
    United States

    Site Not Available

  • Facey Medical Center - Radiant Research

    Mission Hills, California 91345
    United States

    Site Not Available

  • Office of Delmer Henninger, MD

    Murrieta, California 92562
    United States

    Site Not Available

  • Advanced Clinical Research Institute

    Orange, California
    United States

    Site Not Available

  • Center for Clinical Trials, LLC

    Paramount, California 90723
    United States

    Site Not Available

  • Advances in Medicine

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Inland Clinical Research, Inc.

    Riverside, California 92501
    United States

    Site Not Available

  • Institute of Healthcare Assessment, Inc.

    San Diego, California 92120
    United States

    Site Not Available

  • Wetlin Research Associates, Inc.

    San Diego, California 92120
    United States

    Site Not Available

  • San Jose Clinical Research, Inc.

    San Jose, California 95128
    United States

    Site Not Available

  • West Coast Clinical Trials

    Signal Hill, California 90755
    United States

    Site Not Available

  • Allergy & Asthma Medical Group of Diablo Valley, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Northern Colorado Pulmonary Consultants, PC

    Ft. Collins, Colorado 80528
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Site Not Available

  • University Clinical Research, DeLand

    DeLand, Florida 32720
    United States

    Site Not Available

  • nTouch Research

    Melbourne, Florida 32901
    United States

    Site Not Available

  • nTouch Research

    St. Petersburg, Florida 33710
    United States

    Site Not Available

  • AHS Medical Research, Inc.

    Tampa, Florida 33615
    United States

    Site Not Available

  • USF Asthma, Allergy and Immunology

    Tampa, Florida 33613
    United States

    Site Not Available

  • New Horizon Health Research

    Atlanta, Georgia
    United States

    Site Not Available

  • Protocare Trial, Inc.

    Austell, Georgia 30106
    United States

    Site Not Available

  • nTouch Research

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Marietta Pulmonary Medicine

    Marietta, Georgia 30060
    United States

    Site Not Available

  • North Point Pulmonary Associates

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Pulmonary Consultants

    Coeur d'Alene, Idaho 83814
    United States

    Site Not Available

  • University of Chicago - Department of Medicine

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Sneeze, Wheeze and Itch, LLC

    Normal, Illinois 61761
    United States

    Site Not Available

  • Medisphere Medical Research Center, LLC

    Evansville, Indiana 47714
    United States

    Site Not Available

  • South Bend Clinic

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Heart of America Research Institute

    Shawnee Mission, Kansas 66216
    United States

    Site Not Available

  • Bendel Medical Associates

    Lafayette, Louisiana 70503
    United States

    Site Not Available

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • North Shore Research Associates

    Slidell, Louisiana 70461
    United States

    Site Not Available

  • Office of Paul A. Shapero, MD, PA

    Bangor, Maine 04401
    United States

    Site Not Available

  • Primary Care Cardiology Research, Inc.

    Ayer, Massachusetts 01432
    United States

    Site Not Available

  • Center for Clinical Research

    Taunton, Massachusetts 02780
    United States

    Site Not Available

  • ClinSite, Inc.

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Minnesota Lung Center

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • MedEx HealthCare Research, Inc.

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Midwest Chest Consultants, PC

    St. Charles, Missouri 63301-2847
    United States

    Site Not Available

  • C.A.R.E Clinical Research

    St. Louis,, Missouri 63122
    United States

    Site Not Available

  • Office of Keith Popovich, MD

    Butte, Montana 59701
    United States

    Site Not Available

  • Montana Medical Research, LLC

    Missoula, Montana 59804
    United States

    Site Not Available

  • Advanced Biomedical Research of America

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Clinical Research Center of Nevada

    Las Vegas, Nevada 89104
    United States

    Site Not Available

  • Atlantic Research Associates, Inc.

    Margate City, New Jersey 08402
    United States

    Site Not Available

  • UrgentMed Family Practice Medical

    South Bound Brook, New Jersey 08880
    United States

    Site Not Available

  • Lovelace Scientific Resources - NM

    Albuquerque, New Mexico 87108
    United States

    Site Not Available

  • Endwell Family Physicians

    Endwell, New York 13760
    United States

    Site Not Available

  • Asthma & Allergy Associates, PC

    Ithaca, New York 14850
    United States

    Site Not Available

  • N.Y. Pulmonary Associates

    New York City, New York 10016
    United States

    Site Not Available

  • Ridgewood Medical Group

    Rochester, New York 14626
    United States

    Site Not Available

  • Charlotte Lung and Health Center

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • North Carolina Clinical Research

    Raleigh, North Carolina
    United States

    Site Not Available

  • New Hanover Medical Research

    Wilmington, North Carolina 28412
    United States

    Site Not Available

  • Odyssey Research Services

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Community Research Management Associates, Inc.

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • New Horizons Clinical Research, Inc.

    Cincinnati, Ohio 45241
    United States

    Site Not Available

  • COR Clinical Research LLC

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Healthcare Research Consultants

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon 97504
    United States

    Site Not Available

  • Medford Medical Clinic, LLP

    Medford, Oregon 97504
    United States

    Site Not Available

  • Allergy Associates Research Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Northeast Clinical Research Center, Inc.

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Consortium Clinical Research, Ltd.

    Ridley Park, Pennsylvania 19078
    United States

    Site Not Available

  • Safe Harbor Clinical Research

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Spartanburg Pharmaceutical Research

    Spartanburg, South Carolina 29307
    United States

    Site Not Available

  • Volunteer Research Group

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Ben Taub General Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Breath of Life Research Institute

    Houston, Texas 77084
    United States

    Site Not Available

  • S.W. Asthma Institute

    Houston, Texas 77074
    United States

    Site Not Available

  • Wellmed at Northern Hills

    San Antonio, Texas 78217
    United States

    Site Not Available

  • Medsource, Inc.

    Chesapeake, Virginia 23321
    United States

    Site Not Available

  • Pulmonary Associates of Fredericksburg, Inc.

    Fredericksburg, Virginia 22401
    United States

    Site Not Available

  • Commonwealth Clinical Research

    Richmond, Virginia 23226
    United States

    Site Not Available

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia 23225
    United States

    Site Not Available

  • Virginia Adult & Pediatric Allergy & Asthma, PC Research Office

    Richmond, Virginia 23229
    United States

    Site Not Available

  • Pulmonary Research Partners, Inc.

    South Boston, Virginia 24592
    United States

    Site Not Available

  • Pulmonary Consultants, PLLC

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Morgantown Pulmonary Associates

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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