To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD
Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility 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
Sites / Locations
- Pinnacle Research Group
- Princeton Pulmonary Group, PC
- Pulmonary & Sleep Associates of Jasper, PC
- Pulmonary Associates of Mobile, P.C.
- Arizona Clinical Research Center, Inc.
- Northern California Research Corp.
- SARC Research Center
- Irvine Center for Clinical Research
- Scripps Clinic - Chest and Critical Care
- Torrance Clinical Research
- Facey Medical Center - Radiant Research
- Office of Delmer Henninger, MD
- Advanced Clinical Research Institute
- Center for Clinical Trials, LLC
- Advances in Medicine
- Inland Clinical Research, Inc.
- Institute of Healthcare Assessment, Inc.
- Wetlin Research Associates, Inc.
- San Jose Clinical Research, Inc.
- West Coast Clinical Trials
- Allergy & Asthma Medical Group of Diablo Valley, Inc.
- Northern Colorado Pulmonary Consultants, PC
- Clinical Research of West Florida, Inc.
- University Clinical Research, DeLand
- nTouch Research
- nTouch Research
- USF Asthma, Allergy and Immunology
- AHS Medical Research, Inc.
- New Horizon Health Research
- Protocare Trial, Inc.
- nTouch Research
- Marietta Pulmonary Medicine
- North Point Pulmonary Associates
- Pulmonary Consultants
- University of Chicago - Department of Medicine
- Sneeze, Wheeze and Itch, LLC
- Medisphere Medical Research Center, LLC
- South Bend Clinic
- Heart of America Research Institute
- Bendel Medical Associates
- New Orleans Center for Clinical Research
- North Shore Research Associates
- Office of Paul A. Shapero, MD, PA
- Primary Care Cardiology Research, Inc.
- Center for Clinical Research
- ClinSite, Inc.
- Minnesota Lung Center
- MedEx HealthCare Research, Inc.
- Midwest Chest Consultants, PC
- C.A.R.E Clinical Research
- Office of Keith Popovich, MD
- Montana Medical Research, LLC
- Clinical Research Center of Nevada
- Advanced Biomedical Research of America
- Atlantic Research Associates, Inc.
- UrgentMed Family Practice Medical
- Lovelace Scientific Resources - NM
- Endwell Family Physicians
- Asthma & Allergy Associates, PC
- N.Y. Pulmonary Associates
- Ridgewood Medical Group
- Charlotte Lung and Health Center
- North Carolina Clinical Research
- New Hanover Medical Research
- Odyssey Research Services
- Community Research Management Associates, Inc.
- New Horizons Clinical Research, Inc.
- COR Clinical Research LLC
- Healthcare Research Consultants
- Clinical Research Institute of Southern Oregon, PC
- Medford Medical Clinic, LLP
- Allergy Associates Research Center
- Northeast Clinical Research Center, Inc.
- University of Pittsburgh
- Consortium Clinical Research, Ltd.
- Safe Harbor Clinical Research
- Spartanburg Pharmaceutical Research
- Volunteer Research Group
- Ben Taub General Hospital
- S.W. Asthma Institute
- Breath of Life Research Institute
- Wellmed at Northern Hills
- Medsource, Inc.
- Pulmonary Associates of Fredericksburg, Inc.
- Pulmonary Associates of Richmond, Inc.
- Commonwealth Clinical Research
- Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
- Pulmonary Research Partners, Inc.
- Pulmonary Consultants, PLLC
- Morgantown Pulmonary Associates
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
Arformoterol tartrate 50 mcg QD
Salmeterol 42 mcg BID