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

February 21, 2012 updated by: Sunovion

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
799

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall occurrence of adverse events
Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Laboratory parameters
Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
ECG parameters
Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
24-hour holter monitoring parameters
Time Frame: Weeks -1, 0, 13, 26, 39, 52
Weeks -1, 0, 13, 26, 39, 52
Vital signs
Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Plasma arformoterol concentrations
Time Frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Physical examination findings
Time Frame: Weeks -1, 53
Weeks -1, 53

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunovion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 091-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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