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Chronic Obstructive Pulmonary DiseasePhase 3NCT00064415

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

A Phase 3 study testing arformoterol and Salmeterol in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by Sumitomo Pharma America, Inc. at 90 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 35 years and older
What is being tested?
arformoterol and Salmeterol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
799 participants
Where
90 sitesUnited States
Study dates
Jun 2002to Dec 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

90 sites in 1 country.

90 sites in 1 country

United States90 sites

  • Lovelace Scientific Resources - NM

    Albuquerque, New Mexico, 87108

  • Northeast Clinical Research Center, Inc.

    Allentown, Pennsylvania, 18104

  • ClinSite, Inc.

    Ann Arbor, Michigan, 48106

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • New Horizon Health Research

    Atlanta, Georgia

  • Protocare Trial, Inc.

    Austell, Georgia, 30106

  • Primary Care Cardiology Research, Inc.

    Ayer, Massachusetts, 01432

  • Office of Paul A. Shapero, MD, PA

    Bangor, Maine, 04401

  • Princeton Pulmonary Group, PC

    Birmingham, Alabama, 35211

  • Office of Keith Popovich, MD

    Butte, Montana, 59701

  • Charlotte Lung and Health Center

    Charlotte, North Carolina, 28207

  • Medsource, Inc.

    Chesapeake, Virginia, 23321

  • University of Chicago - Department of Medicine

    Chicago, Illinois, 60637

  • Community Research Management Associates, Inc.

    Cincinnati, Ohio, 45219

  • New Horizons Clinical Research, Inc.

    Cincinnati, Ohio, 45241

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Pulmonary Consultants

    Coeur d'Alene, Idaho, 83814

  • nTouch Research

    Decatur, Georgia, 30033

  • University Clinical Research, DeLand

    DeLand, Florida, 32720

  • Safe Harbor Clinical Research

    East Providence, Rhode Island, 02914

  • Endwell Family Physicians

    Endwell, New York, 13760

  • Medisphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Northern California Research Corp.

    Fair Oaks, California, 95628

  • Odyssey Research Services

    Fargo, North Dakota, 58104

  • Northern Colorado Pulmonary Consultants, PC

    Fort Collins, Colorado, 80528

  • Pulmonary Associates of Fredericksburg, Inc.

    Fredericksburg, Virginia, 22401

  • SARC Research Center

    Fresno, California, 93720

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • S.W. Asthma Institute

    Houston, Texas, 77074

  • Breath of Life Research Institute

    Houston, Texas, 77084

  • Irvine Center for Clinical Research

    Irvine, California, 92618

  • Asthma & Allergy Associates, PC

    Ithaca, New York, 14850

  • Pulmonary & Sleep Associates of Jasper, PC

    Jasper, Alabama, 35501

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Scripps Clinic - Chest and Critical Care

    La Jolla, California, 92037

  • Bendel Medical Associates

    Lafayette, Louisiana, 70503

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89104

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89119

  • Torrance Clinical Research

    Los Angeles, California, 90505

  • Atlantic Research Associates, Inc.

    Margate City, New Jersey, 08402

  • Marietta Pulmonary Medicine

    Marietta, Georgia, 30060

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon, 97504

  • Medford Medical Clinic, LLP

    Medford, Oregon, 97504

  • nTouch Research

    Melbourne, Florida, 32901

  • Minnesota Lung Center

    Minneapolis, Minnesota, 55407

  • Facey Medical Center - Radiant Research

    Mission Hills, California, 91345

  • Montana Medical Research, LLC

    Missoula, Montana, 59804

  • Pulmonary Associates of Mobile, P.C.

    Mobile, Alabama, 36608

  • Morgantown Pulmonary Associates

    Morgantown, West Virginia, 26505

  • Office of Delmer Henninger, MD

    Murrieta, California, 92562

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • N.Y. Pulmonary Associates

    New York, New York, 10016

  • Sneeze, Wheeze and Itch, LLC

    Normal, Illinois, 61761

  • COR Clinical Research LLC

    Oklahoma City, Oklahoma, 73103

  • Advanced Clinical Research Institute

    Orange, California

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Allergy Associates Research Center

    Portland, Oregon, 97213

  • North Carolina Clinical Research

    Raleigh, North Carolina

  • Advances in Medicine

    Rancho Mirage, California, 92270

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23225

  • Commonwealth Clinical Research

    Richmond, Virginia, 23226

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

    Richmond, Virginia, 23229

  • Consortium Clinical Research, Ltd.

    Ridley Park, Pennsylvania, 19078

  • Inland Clinical Research, Inc.

    Riverside, California, 92501

  • Ridgewood Medical Group

    Rochester, New York, 14626

  • North Point Pulmonary Associates

    Roswell, Georgia, 30076

  • Midwest Chest Consultants, PC

    Saint Charles, Missouri, 63301-2847

  • Wellmed at Northern Hills

    San Antonio, Texas, 78217

  • Institute of Healthcare Assessment, Inc.

    San Diego, California, 92120

  • Wetlin Research Associates, Inc.

    San Diego, California, 92120

  • San Jose Clinical Research, Inc.

    San Jose, California, 95128

  • Heart of America Research Institute

    Shawnee Mission, Kansas, 66216

  • West Coast Clinical Trials

    Signal Hill, California, 90755

  • North Shore Research Associates

    Slidell, Louisiana, 70461

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Pulmonary Research Partners, Inc.

    South Boston, Virginia, 24592

  • UrgentMed Family Practice Medical

    South Bound Brook, New Jersey, 08880

  • Spartanburg Pharmaceutical Research

    Spartanburg, South Carolina, 29307

  • MedEx HealthCare Research, Inc.

    St Louis, Missouri, 63108

  • C.A.R.E Clinical Research

    St Louis, Missouri, 63122

  • nTouch Research

    St. Petersburg, Florida, 33710

  • Pulmonary Consultants, PLLC

    Tacoma, Washington, 98405

  • USF Asthma, Allergy and Immunology

    Tampa, Florida, 33613

  • AHS Medical Research, Inc.

    Tampa, Florida, 33615

  • Center for Clinical Research

    Taunton, Massachusetts, 02780

  • Arizona Clinical Research Center, Inc.

    Tucson, Arizona, 85712

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

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

    Walnut Creek, California, 94598

  • New Hanover Medical Research

    Wilmington, North Carolina, 28412

Other trials in United States

About this 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

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

Read the 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.

Being tested
arformoterol, Salmeterol
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arformoterolDrug

    Also called Brovana Inhalation Solution, (R,R)-Formoterol

    Arformoterol inhalation solution, 50 mcg QD

  • SalmeterolDrug

    Also called Serevent MDI, racemic formoterol

    Salmeterol MDI, 42 mcg BID

Study groups in NCT00064415
Study groupRoleWhat they receive
1ExperimentalArformoterol tartrate 50 mcg QD
Receives: Drug: arformoterol
2Active comparatorSalmeterol 42 mcg BID
Receives: Drug: Salmeterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall occurrence of adverse events

    Measured: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

Secondary outcomes (6)

  1. Laboratory parameters

    Measured: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

  2. ECG parameters

    Measured: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

  3. 24-hour holter monitoring parameters

    Measured: Weeks -1, 0, 13, 26, 39, 52

  4. Vital signs

    Measured: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

  5. Plasma arformoterol concentrations

    Measured: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

  6. Physical examination findings

    Measured: Weeks -1, 53

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2003 (estimated)
  2. Study startJun 2002
  3. Primary completionDec 2004
  4. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
799 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064415
Sponsor's protocol ID
091-060
Status last verified
Feb 2012
First submitted
8 Jul 2003
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing arformoterol and Salmeterol in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by Sumitomo Pharma America, Inc. at 90 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall occurrence of adverse events (time frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00064415.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.

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