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To Evaluate the Long-Term Safety of (R,R)-Formoterol in Subjects With COPD
This study has been completed.
First Received: July 8, 2003   Last Updated: August 12, 2008   History of Changes
Sponsor: Sepracor, Inc.
Information provided by: Sepracor, Inc.
ClinicalTrials.gov Identifier: NCT00064415
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Drug: arformoterol
Drug: Salmeterol
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: A Multicenter, Open-Label, Randomized, Active-Controlled, Parallel Group Chronic Safety Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:
  • Overall occurrence of adverse events [ Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Laboratory parameters [ Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ] [ Designated as safety issue: Yes ]
  • ECG parameters [ Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ] [ Designated as safety issue: Yes ]
  • 24-hour holter monitoring parameters [ Time Frame: Weeks -1, 0, 13, 26, 39, 52 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ] [ Designated as safety issue: Yes ]
  • Plasma arformoterol concentrations [ Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 ] [ Designated as safety issue: No ]
  • Physical examination findings [ Time Frame: Weeks -1, 53 ] [ Designated as safety issue: No ]

Enrollment: 799
Study Start Date: June 2002
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Arformoterol tartrate 50 mcg QD
Drug: arformoterol
Arformoterol inhalation solution, 50 mcg QD
2: Active Comparator
Salmeterol 42 mcg BID
Drug: Salmeterol
Salmeterol MDI, 42 mcg BID

Detailed 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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064415

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

No publications provided

Responsible Party: Sepracor ( Arformoterol Medical Director )
Study ID Numbers: 091-060
Study First Received: July 8, 2003
Last Updated: August 12, 2008
ClinicalTrials.gov Identifier: NCT00064415     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Pulmonary Emphysema
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Formoterol
Bronchitis
Emphysema
Salmeterol
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Pharmacologic Actions
Bronchitis, Chronic
Autonomic Agents
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 30, 2009