Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD
A Double-Blind, Double-Dummy, Randomized, Placebo- and Active-Controlled, Multicenter, Parallel-Group Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
741
1 country
65
Brief Summary
The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 chronic-obstructive-pulmonary-disease
Started Apr 2002
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 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
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFebruary 22, 2012
February 1, 2012
1.9 years
July 8, 2003
February 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
percent change in trough FEV1 from study baseline to the end of the dosing interval (12 hours post-second dose for the BID treatment arms and 24 hours postdose for the QD treatment arm) over the double-blind period.
Weeks -2, 0, 3, 6, 9, 12
Secondary Outcomes (16)
time-normalized area under the percent change from visit predose curve for FEV1 over 12 hours (nAUC0-12-P)
Weeks -2, 0, 3, 6, 9, 12
Peak percent of predicted FEV1
Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change in FEV1 from study baseline over 12 hours (nAUC0-12-B)
Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change from visit predose curve for FEV1 over 24 hours (nAUC0-24-P)
Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change in FEV1 from study baseline curve over 24 hours (nAUC0-24-B)
Weeks -2, 0, 3, 6, 9, 12
- +11 more secondary outcomes
Study Arms (5)
1
EXPERIMENTALArformoterol 50 mcg QD and placebo MDI
2
EXPERIMENTALArformoterol 25 mcg BID and Placebo MDI
3
EXPERIMENTALArformoterol 15 mcg BID and placebo MDI
4
ACTIVE COMPARATORSalmeterol MDI 42 mcg BID and placebo inhalation solution
5
PLACEBO COMPARATORPlacebo MDI and placebo inhalation solution
Interventions
Eligibility Criteria
You may qualify if:
- Be willing to comply with study procedures and visit schedule
- Are at least 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: documented surgically sterile, OR postmenopausal.
- Have a primary diagnosis of COPD. 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).
- Have a chest x-ray that is consistent with the diagnosis of COPD and taken \<3 months prior to study start
- Able to complete all study questionnaires and logs reliably
You may not qualify if:
- Female subject who is pregnant or lactating
- Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another investigational drug study
- Subject whose schedule or travel prevents the completion of all required visits
- Are scheduled for in-patient hospitalization, including elective surgery during the trial
- Have life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days
- History of asthma or any chronic respiratory disease other than COPD (chronic bronchitis and/or emphysema)
- Have clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
- Have a history of cancer except non-melanomatous skin cancer
- Have a history of lung resection of more than one full lobe
- Requires continuous supplemental oxygen therapy.
- Has 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 arformoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations
- Have a history of substance abuse or drug abuse within 12 months, or with a positive urine drug screen
- Are using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Pulmonary & Sleep Associates of Jasper, PC
Jasper, Alabama, 35501, United States
Pulmonary Associates, PA
Phoenix, Arizona, 85006, 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
California Research Medical Group, Inc.
Fullerton, California, 92835, United States
Radiant Research-Irvine
Irvine, California, 92618, United States
West Coast Clinical Trials
Newport Beach, California, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
Advances in Medicine
Rancho Mirage, California, 92270, United States
Institute of Healthcare Assessment, Inc.
San Diego, California, 92120, United States
San Jose Clinical Research
San Jose, California, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California, 94598, United States
Colorado Pulmonary Associates
Denver, Colorado, 80218, United States
Northern Colorado Pulmonary Consultants, PC
Fort Collins, Colorado, United States
Physicians Research Center, Inc.
Hartford, Connecticut, 06106, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
University Clinical Research, DeLand
DeLand, Florida, 32720, United States
Mt. Sinai Medical Center
Miami Beach, Florida, 33140, United States
Clinical Pharmacology Services
Tampa, Florida, 33617, United States
Protocare Trial, Inc.
Austell, Georgia, 30106, United States
Marietta Pulmonary Medicine
Marietta, Georgia, 30060, United States
Office of Bradley Sakran, MD, PC
O'Fallon, Illinois, 62269, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Family Allergy & Asthma Research Institute
Louisville, Kentucky, 40215, United States
Cumberland Lung and Sleep Specialists
Somerset, Kentucky, United States
Bendel Medical Associates/Research
Lafayette, Louisiana, 70503, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
North Shore Research Associates
Slidell, Louisiana, 70461, United States
Sunset Medical Research
Sunset, Louisiana, 70584, United States
University of Maryland-Airways Research Center
Baltimore, Maryland, United States
Institute of Asthma and Allergy
Wheaton, Maryland, United States
Pro-Medica Clinical Research Center
Boston, Massachusetts, 02135, United States
ClinSite, Inc.
Ann Arbor, Michigan, 48106, 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, United States
Montana Medical Research, LLC
Missoula, Montana, United States
VA Medical Center
Omaha, Nebraska, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89119, United States
Pulmonary Medicine
Chapel Hill, North Carolina, 27599, United States
Charlotte Lung and Health Center
Charlotte, North Carolina, 28207, United States
Carolina Pharmaceutical Research, Inc.
Statesville, North Carolina, 28625, United States
New Hanover Medical Research
Wilmington, North Carolina, 28412, United States
New Horizons Clinical Research, Inc.
Cincinnati, Ohio, 45241, United States
COR Clinical Research LLC
Oklahoma City, Oklahoma, 73103, United States
Allergy Associates Research Center
Portland, Oregon, 97213, United States
Northeast Clinical Research Centers, Inc.
Allentown, Pennsylvania, 18104, United States
Keystone Clinical Solutions
Altoona, Pennsylvania, 16602, United States
Philadelphia Health Associates - Adult Medicine
Philadelphia, Pennsylvania, 19146, 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
Breath of Life Research Institute
Houston, Texas, 77084, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, 22401, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225, United States
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington, 98225, United States
University of Wisconsin-Medical School
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- 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
April 1, 2002
Primary Completion
March 1, 2004
Study Completion
March 1, 2004
Last Updated
February 22, 2012
Record last verified: 2012-02