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To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD Clinical research trials and To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD. To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD clinical trial. Subjects frequently obtain the most expert healthcare possible for their To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.

Home > "T" Clinical Trials Conditions > To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD

To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD



To evaluate the long-term safety of (R,R)-formoterol in subjects with COPD

For Condition: Chronic Bronchitis,Emphysema,Chronic Obstructive Pulmonary Disease
Status: No longer recruiting
Sponsor(s): Sepracor, Inc. ,
Synopsis: The purpose of this study is to determine the long-term safety of (R,R)-formoterol over a period of 12 months in subjects with COPD
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, 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. - 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
Total Enrollment: 750

Location and Contact Information:

nTouch Research
Melbourne,  Florida,  32901
United States
 

Asthma & Allergy Associates, PC
Ithaca,  New York,  14850
United States
 

Pinnacle Research Group
Anniston,  Alabama,  36207
United States
 

Advanced Biomedical Research of America
Las Vegas,  Nevada,  89119
United States
 

New Horizons Clinical Research, Inc.
Cincinnati,  Ohio,  45241
United States
 

Advances in Medicine
Rancho Mirage,  California,  92270
United States
 

Volunteer Research Group
Knoxville,  Tennessee,  37920
United States
 

Atlantic Research Associates, Inc.
Margate City,  New Jersey,  08402
United States
 

Heart of America Research Institute
Shawnee Mission,  Kansas,  66216
United States
 

Clinical Research of West Florida, Inc.
Clearwater,  Florida,  33765
United States
 

Endwell Family Physicians
Endwell,  New York,  13760
United States
 

New Orleans Center for Clinical Research
New Orleans,  Louisiana,  70119
United States
 

USF Asthma, Allergy and Immunology
Tampa,  Florida,  33613
United States
 

Scripps Clinic - Chest and Critical Care
LaJolla,  California,  92037
United States
 

Montana Medical Research, LLC
Missoula,  Montana,  59804
United States
 

Midwest Chest Consultants, PC
St. Charles,  Missouri,  63301-2847
United States
 

North Point Pulmonary Associates
Roswell,  Georgia,  30076
United States
 

New Horizon Health Research
Atlanta,  Georgia, 
United States
 

Morgantown Pulmonary Associates
Morgantown,  West Virginia,  26505
United States
 

Ridgewood Medical Group
Rochester,  New York,  14626
United States
 

Healthcare Research Consultants
Tulsa,  Oklahoma,  74135
United States
 

Consortium Clinical Research, Ltd.
Ridley Park,  Pennsylvania,  19078
United States
 

S.W. Asthma Institute
Houston,  Texas,  77074
United States
 

Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
Richmond,  Virginia,  23229
United States
 

Princeton Pulmonary Group, PC
Birmingham,  Alabama,  35211
United States
 

Lovelace Scientific Resources - NM
Albuquerque,  New Mexico,  87108
United States
 

Facey Medical Center - Radiant Research
Mission Hills,  California,  91345
United States
 

Spartanburg Pharmaceutical Research
Spartanburg,  South Carolina,  29307
United States
 

Sneeze, Wheeze and Itch, LLC
Normal,  Illinois,  61761
United States
 

Clinical Research Center of Nevada
Las Vegas,  Nevada,  89104
United States
 

Northern Colorado Pulmonary Consultants, PC
Ft. Collins,  Colorado,  80528
United States
 

Northern California Research Corp.
Fair Oaks,  California,  95628
United States
 

Institute of Healthcare Assessment, Inc.
San Diego,  California,  92120
United States
 

AHS Medical Research, Inc.
Tampa,  Florida,  33615
United States
 

Irvine Center for Clinical Research
Irvine,  California,  92618
United States
 

Wetlin Research Associates, Inc.
San Diego,  California,  92120
United States
 

Inland Clinical Research, Inc.
Riverside,  California,  92501
United States
 

Breath of Life Research Institute
Houston,  Texas,  77084
United States
 

Allergy Associates Research Center
Portland,  Oregon,  97213
United States
 

Ben Taub General Hospital
Houston,  Texas,  77030
United States
 

Pulmonary Consultants
Coeur D Alene,  Idaho,  83814
United States
 

Wellmed at Northern Hills
San Antonio,  Texas,  78217
United States
 

Center for Clinical Trials, LLC
Paramount,  California,  90723
United States
 

C.A.R.E Clinical Research
St. Louis,  Missouri,  63122
United States
 

North Carolina Clinical Research
Raleigh,  North Carolina, 
United States
 

Minnesota Lung Center
Minneapolis,  Minnesota,  55407
United States
 

Charlotte Lung and Health Center
Charlotte,  North Carolina,  28207
United States
 

Marietta Pulmonary Medicine
Marietta,  Georgia,  30060
United States
 

New Hanover Medical Research
Wilmington,  North Carolina,  28412
United States
 

Medsource, Inc.
Chesapeake,  Virginia,  23321
United States
 

Office of Paul A. Shapero, MD, PA
Bangor,  Maine,  04401
United States
 

Medford Medical Clinic, LLP
Medforo,  Oregon,  97504
United States
 

Pulmonary & Sleep Associates of Jasper, PC
Jasper,  Alabama,  35501
United States
 

nTouch Research
St. Petersburg,  Florida,  33710
United States
 

Safe Harbor Clinical Research
Providence,  Rhode Island,  02914
United States
 

San Jose Clinical Research, Inc.
San Jose,  California,  95128
United States
 

MedEx HealthCare Research, Inc.
St. Louis,  Missouri,  63108
United States
 

Primary Care Cardiology Research, Inc.
Ayer,  Massachusetts,  01432
United States
 

UrgentMed Family Practice Medical
South Bound Brook,  New Jersey,  08880
United States
 

Bendel Medical Associates
Lafayette,  Louisiana,  70503
United States
 

ClinSite, Inc.
Ann Arbor,  Michigan,  48106
United States
 

Pulmonary Research Partners, Inc.
South Boston,  Virginia,  24592
United States
 

Pulmonary Associates of Richmond, Inc.
Richmond,  Virginia,  23225
United States
 

Torrance Clinical Research
Los Angeles,  California,  90505
United States
 

University of Chicago - Department of Medicine
Chicago,  Illinois,  60637
United States
 

nTouch Research
Decatur,  Georgia,  30033
United States
 

Community Research Management Associates, Inc.
Cincinnati,  Ohio,  45219
United States
 

Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg,  Virginia,  22401
United States
 

Protocare Trial, Inc.
Austell,  Georgia,  30106
United States
 

Pulmonary Consultants, PLLC
Tacoma,  Washington,  98405
United States
 

South Bend Clinic
South Bend,  Indiana,  46617
United States
 

Odyssey Research Services
Fargo,  North Dakota,  58104
United States
 

N.Y. Pulmonary Associates
New York City,  New York,  10016
United States
 

Office of Delmer Henninger, MD
Murrieta,  California,  92562
United States
 

University Clinical Research, DeLand
Deland,  Florida,  32720
United States
 

Office of Keith Popovich, MD
Butte,  Montana,  59701
United States
 

Advanced Clinical Research Institute
Orange,  California, 
United States
 

Medisphere Medical Research Center, LLC
Evansville,  Indiana,  47714
United States
 

Center for Clinical Research
Taunton,  Massachusetts,  02780
United States
 

University of Pittsburgh
Pittsburgh,  Pennsylvania,  15213
United States
 

Clinical Research Institute of Southern Oregon, PC
Medforo,  Oregon,  97504
United States
 

Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek,  California,  94598
United States
 

West Coast Clinical Trials
Signal Hill,  California,  90755
United States
 

Pulmonary Associates of Mobile, P.C.
Mobile,  Alabama,  36608
United States
 

SARC Research Center
Fresno,  California,  93720
United States
 

Northeast Clinical Research Center, Inc.
Allentown,  Pennsylvania,  18104
United States
 

North Shore Research Associates
Slidell,  Louisiana,  70461
United States
 

Commonwealth Clinical Research
Richmond,  Virginia,  23226
United States
 

Arizona Clinical Research Center, Inc.
Tucson,  Arizona,  85712
United States
 

COR Clinical Research LLC
Oklahoma City,  Oklahoma,  73103
United States
 


Additional Information:
Study ID Numbers:
  091-060; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064415

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