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Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD Clinical research trials and Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD. Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD clinical trial. Test subjects typically receive the most effective healthcare possible for their Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD  Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD
Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD
For Condition: Chronic Obstructive Pulmonary Disease,Chronic Bronchitis,Emphysema
Status: No longer recruiting
Sponsor(s): Sepracor, Inc. ,
Synopsis: The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of (R,R)-formoterol administered for 12 weeks as maintenance treatment in patients with COPD
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 35 Years/
Genders: Both
Protocol Entry Criteria: 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. - 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. Women taking hormone replacement therapy may have a FSH level of >30 IU/L - 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). - Medical Research Council (MRC) Dyspnea Scale Score .2 - Have a baseline FEV1 <65% of predicted normal value and >0.70 L documented at two of three visits prior to randomization - Have an FEV1/forced vital capacity (FVC) ratio <70% documented at two of three visits prior to randomization - Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months prior to Visit 1 - 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: - Subject who is 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 - 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 a blood eosinophil count >5% of total white blood cell count - 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. The use of supplemental oxygen, not to exceed 2L/minute, at nighttime only and/or only during exercise is allowed. - 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 (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, or with a positive urine drug screen - Have a clinically significant abnormal laboratory value - Have a clinically significant abnormal 12-lead ECG that may jeopardize the subject’s ability to complete the study - Are using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers)
Total Enrollment: 800
Location and Contact Information:
COR Clinical Research LLC
Oklahoma City, Oklahoma, 73103
United States
University Clinical Research, DeLand
Deland, Florida, 32720
United States
Central Texas Health Research
New Braunfels, Texas, 78130
United States
C.A.R.E Clinical Research
St. Louis, Missouri, 63122
United States
Pro-Medica Clinical Research Center
Boston, Massachusetts, 02135
United States
Pulmonary Associates, PA
Phoenix, Arizona, 85006
United States
Advances in Medicine
Rancho Mirage, California, 92270
United States
Clinical Pharmacology Services
Tampa, Florida, 33617
United States
Family Allergy & Asthma Research Institute
Louisville, Kentucky, 40215
United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89119
United States
Allergy Associates Research Center
Portland, Oregon, 97213
United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225
United States
Keystone Clinical Solutions
Altoona, Pennsylvania, 16602
United States
Pulmonary & Sleep Associates of Jasper, PC
Jasper, Alabama, 35501
United States
Center for Clinical Trials, LLC
Paramount, California, 90723
United States
New Horizons Clinical Research, Inc.
Cincinnati, Ohio, 45241
United States
Office of Keith Popovich, MD
Butte, Montana,
United States
Northern California Research Corp.
Fair Oaks, California, 95628
United States
Marietta Pulmonary Medicine
Marietta, Georgia, 30060
United States
Montana Medical Research, LLC
Missoula, Montana,
United States
Institute of Asthma and Allergy
Wheaton, Maryland,
United States
Washington Hospital Center
Washington D.C., District of Columbia,
United States
North Shore Research Associates
Slidell, Louisiana, 70461
United States
ClinSite, Inc.
Ann Arbor, Michigan, 48106
United States
Northern Colorado Pulmonary Consultants, PC
Fort Collins, Colorado,
United States
Philadelphia Health Associates - Adult Medicine
Philadelphia, Pennsylvania, 19146
United States
Volunteer Research Group
Knoxville, Tennessee, 37920
United States
West Coast Clinical Trials
Newport Beach, California,
United States
University of Wisconsin-Medical School
Madison, Wisconsin, 53792
United States
Consortium Clinical Research, Ltd.
Ridley Park, Pennsylvania, 19078
United States
Cumberland Lung and Sleep Specialists
Somerset, Kentucky,
United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119
United States
VA Medical Center
Omaha, Nebraska,
United States
MedEx HealthCare Research, Inc.
St. Louis, Missouri, 63108
United States
Safe Harbor Clinical Research
Providence, Rhode Island, 02914
United States
Mt. Sinai Medical Center
Miami, Florida, 33140
United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
United States
Institute of Healthcare Assessment, Inc.
San Diego, California, 92120
United States
California Research Medical Group, Inc.
Fullerton, California, 92835
United States
Carolina Pharmaceutical Research, Inc.
Statesville, North Carolina, 28625
United States
Spartanburg Pharmaceutical Research
Spartanburg, South Carolina, 29307
United States
Pulmonary Medicine
Chapel Hill, North Carolina, 27599
United States
Bendel Medical Associates/Research
Lafayette, Louisiana, 70503
United States
Protocare Trial, Inc.
Austell, Georgia, 30106
United States
Office of Bradley Sakran, MD, PC
O Fallon, Illinois, 62269
United States
Colorado Pulmonary Associates
Denver, Colorado, 80218
United States
Sylvana Research Associates
San Antonio, Texas, 78229
United States
Radiant Research-Irvine
Irvine, California, 92618
United States
Breath of Life Research Institute
Houston, Texas, 77084
United States
New Orleans Center for Clinical Research
New Orleans, Louisiana,
United States
Charlotte Lung and Health Center
Charlotte, North Carolina, 28207
United States
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington, 98225
United States
Physicians Research Center, Inc.
Hartford, Connecticut, 06106
United States
Sunset Medical Research
Sunset, Louisiana, 70584
United States
SARC Research Center
Fresno, California, 93720
United States
Midwest Chest Consultants, PC
St. Charles, Missouri, 63301-2847
United States
San Jose Clinical Research
San Jose, California,
United States
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, 22401
United States
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85712
United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California, 94598
United States
South Bend Clinic
South Bend, Indiana, 46617
United States
University of Maryland-Airways Research Center
Baltimore, Maryland,
United States
Northeast Clinical Research Centers, Inc.
Allentown, Pennsylvania, 18104
United States
New Hanover Medical Research
Wilmington, North Carolina, 28412
United States
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115
United States
Additional Information:
Study ID Numbers: 091-051;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064402
Other Emphysema Studies:
1. Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
2. Yoga for Treating Shortness of Breath in Chronic Obstructive Pulmonary Disease (COPD)
3. Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD
4. To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD
Related Studies:
Other Emphysema Clinical Trials
Other California Clinical Trials
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Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD
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