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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema; Chronic Bronchitis
• Intervention / Treatment: Drug: arformoterol; Drug: Salmeterol

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 799
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Arformoterol tartrate 50 mcg QD	Drug: arformoterol; Arformoterol inhalation solution, 50 mcg QD; Other Names: Brovana Inhalation Solution; (R,R)-Formoterol
Active Comparator: 2; Salmeterol 42 mcg BID	Drug: Salmeterol; Salmeterol MDI, 42 mcg BID; Other Names: Serevent MDI; racemic formoterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall occurrence of adverse events	Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

Secondary Outcome Measures

Outcome Measure	Time Frame
Laboratory parameters	Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
ECG parameters	Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
24-hour holter monitoring parameters	Weeks -1, 0, 13, 26, 39, 52
Vital signs	Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Plasma arformoterol concentrations	Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Physical examination findings	Weeks -1, 53

Collaborators and Investigators

• Sponsor: Sunovion

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: July 8, 2003
• First Submitted That Met QC Criteria: July 8, 2003
• First Posted (Estimate): July 9, 2003

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 21, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis; Bronchitis, Chronic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Salmeterol Xinafoate; Formoterol Fumarate
• Other Study ID Numbers: 091-060