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
1 other identifier
interventional
799
1 country
90
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Jun 2002
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 8, 2003
CompletedFirst Posted
Study publicly available on registry
July 9, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFebruary 22, 2012
February 1, 2012
2.5 years
July 8, 2003
February 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Overall occurrence of adverse events
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALArformoterol tartrate 50 mcg QD
2
ACTIVE COMPARATORSalmeterol 42 mcg BID
Interventions
Arformoterol inhalation solution, 50 mcg QD
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Princeton Pulmonary Group, PC
Birmingham, Alabama, 35211, United States
Pulmonary & Sleep Associates of Jasper, PC
Jasper, Alabama, 35501, United States
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, 36608, United States
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85712, United States
Northern California Research Corp.
Fair Oaks, California, 95628, United States
SARC Research Center
Fresno, California, 93720, United States
Irvine Center for Clinical Research
Irvine, California, 92618, United States
Scripps Clinic - Chest and Critical Care
La Jolla, California, 92037, United States
Torrance Clinical Research
Los Angeles, California, 90505, United States
Facey Medical Center - Radiant Research
Mission Hills, California, 91345, United States
Office of Delmer Henninger, MD
Murrieta, California, 92562, United States
Advanced Clinical Research Institute
Orange, California, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
Advances in Medicine
Rancho Mirage, California, 92270, United States
Inland Clinical Research, Inc.
Riverside, California, 92501, United States
Institute of Healthcare Assessment, Inc.
San Diego, California, 92120, United States
Wetlin Research Associates, Inc.
San Diego, California, 92120, United States
San Jose Clinical Research, Inc.
San Jose, California, 95128, United States
West Coast Clinical Trials
Signal Hill, California, 90755, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California, 94598, United States
Northern Colorado Pulmonary Consultants, PC
Fort Collins, Colorado, 80528, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
University Clinical Research, DeLand
DeLand, Florida, 32720, United States
nTouch Research
Melbourne, Florida, 32901, United States
nTouch Research
St. Petersburg, Florida, 33710, United States
USF Asthma, Allergy and Immunology
Tampa, Florida, 33613, United States
AHS Medical Research, Inc.
Tampa, Florida, 33615, United States
New Horizon Health Research
Atlanta, Georgia, United States
Protocare Trial, Inc.
Austell, Georgia, 30106, United States
nTouch Research
Decatur, Georgia, 30033, United States
Marietta Pulmonary Medicine
Marietta, Georgia, 30060, United States
North Point Pulmonary Associates
Roswell, Georgia, 30076, United States
Pulmonary Consultants
Coeur d'Alene, Idaho, 83814, United States
University of Chicago - Department of Medicine
Chicago, Illinois, 60637, United States
Sneeze, Wheeze and Itch, LLC
Normal, Illinois, 61761, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Heart of America Research Institute
Shawnee Mission, Kansas, 66216, United States
Bendel Medical Associates
Lafayette, Louisiana, 70503, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
North Shore Research Associates
Slidell, Louisiana, 70461, United States
Office of Paul A. Shapero, MD, PA
Bangor, Maine, 04401, United States
Primary Care Cardiology Research, Inc.
Ayer, Massachusetts, 01432, United States
Center for Clinical Research
Taunton, Massachusetts, 02780, United States
ClinSite, Inc.
Ann Arbor, Michigan, 48106, United States
Minnesota Lung Center
Minneapolis, Minnesota, 55407, United States
Midwest Chest Consultants, PC
Saint Charles, Missouri, 63301-2847, United States
MedEx HealthCare Research, Inc.
St Louis, Missouri, 63108, United States
C.A.R.E Clinical Research
St Louis, Missouri, 63122, United States
Office of Keith Popovich, MD
Butte, Montana, 59701, United States
Montana Medical Research, LLC
Missoula, Montana, 59804, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89119, United States
Atlantic Research Associates, Inc.
Margate City, New Jersey, 08402, United States
UrgentMed Family Practice Medical
South Bound Brook, New Jersey, 08880, United States
Lovelace Scientific Resources - NM
Albuquerque, New Mexico, 87108, United States
Endwell Family Physicians
Endwell, New York, 13760, United States
Asthma & Allergy Associates, PC
Ithaca, New York, 14850, United States
N.Y. Pulmonary Associates
New York, New York, 10016, United States
Ridgewood Medical Group
Rochester, New York, 14626, United States
Charlotte Lung and Health Center
Charlotte, North Carolina, 28207, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
New Hanover Medical Research
Wilmington, North Carolina, 28412, United States
Odyssey Research Services
Fargo, North Dakota, 58104, United States
Community Research Management Associates, Inc.
Cincinnati, Ohio, 45219, United States
New Horizons Clinical Research, Inc.
Cincinnati, Ohio, 45241, United States
COR Clinical Research LLC
Oklahoma City, Oklahoma, 73103, United States
Healthcare Research Consultants
Tulsa, Oklahoma, 74135, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504, United States
Medford Medical Clinic, LLP
Medford, Oregon, 97504, United States
Allergy Associates Research Center
Portland, Oregon, 97213, United States
Northeast Clinical Research Center, Inc.
Allentown, Pennsylvania, 18104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Consortium Clinical Research, Ltd.
Ridley Park, Pennsylvania, 19078, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914, United States
Spartanburg Pharmaceutical Research
Spartanburg, South Carolina, 29307, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
S.W. Asthma Institute
Houston, Texas, 77074, United States
Breath of Life Research Institute
Houston, Texas, 77084, United States
Wellmed at Northern Hills
San Antonio, Texas, 78217, United States
Medsource, Inc.
Chesapeake, Virginia, 23321, United States
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, 22401, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225, United States
Commonwealth Clinical Research
Richmond, Virginia, 23226, United States
Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
Richmond, Virginia, 23229, United States
Pulmonary Research Partners, Inc.
South Boston, Virginia, 24592, United States
Pulmonary Consultants, PLLC
Tacoma, Washington, 98405, United States
Morgantown Pulmonary Associates
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2003
First Posted
July 9, 2003
Study Start
June 1, 2002
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
February 22, 2012
Record last verified: 2012-02