Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of 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: 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 Exclusion Criteria: 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)
Sites / Locations
- Pulmonary & Sleep Associates of Jasper, PC
- Pulmonary Associates, PA
- Arizona Clinical Research Center, Inc.
- Northern California Research Corp.
- SARC Research Center
- California Research Medical Group, Inc.
- Radiant Research-Irvine
- West Coast Clinical Trials
- Center for Clinical Trials, LLC
- Advances in Medicine
- Institute of Healthcare Assessment, Inc.
- San Jose Clinical Research
- Allergy & Asthma Medical Group of Diablo Valley, Inc.
- Colorado Pulmonary Associates
- Northern Colorado Pulmonary Consultants, PC
- Physicians Research Center, Inc.
- Washington Hospital Center
- Clinical Research of West Florida, Inc.
- University Clinical Research, DeLand
- Mt. Sinai Medical Center
- Clinical Pharmacology Services
- Protocare Trial, Inc.
- Marietta Pulmonary Medicine
- Office of Bradley Sakran, MD, PC
- South Bend Clinic
- Family Allergy & Asthma Research Institute
- Cumberland Lung and Sleep Specialists
- Bendel Medical Associates/Research
- Best Clinical Trials, LLC
- New Orleans Center for Clinical Research
- New Orleans Center for Clinical Research
- North Shore Research Associates
- Sunset Medical Research
- University of Maryland-Airways Research Center
- Institute of Asthma and Allergy
- Pro-Medica Clinical Research Center
- ClinSite, Inc.
- MedEx HealthCare Research, Inc.
- Midwest Chest Consultants, PC
- C.A.R.E Clinical Research
- Office of Keith Popovich, MD
- Montana Medical Research, LLC
- VA Medical Center
- Advanced Biomedical Research of America
- Pulmonary Medicine
- Charlotte Lung and Health Center
- Carolina Pharmaceutical Research, Inc.
- New Hanover Medical Research
- New Horizons Clinical Research, Inc.
- COR Clinical Research LLC
- Allergy Associates Research Center
- Northeast Clinical Research Centers, Inc.
- Keystone Clinical Solutions
- Philadelphia Health Associates - Adult Medicine
- Consortium Clinical Research, Ltd.
- Safe Harbor Clinical Research
- Spartanburg Pharmaceutical Research
- Volunteer Research Group
- Breath of Life Research Institute
- Central Texas Health Research
- Sylvana Research Associates
- Pulmonary Associates of Fredericksburg, Inc.
- Pulmonary Associates of Richmond, Inc.
- Bellingham Asthma, Allergy & Immunology Clinic
- University of Wisconsin-Medical School
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
1
2
3
4
5
Arformoterol 50 mcg QD and placebo MDI
Arformoterol 25 mcg BID and Placebo MDI
Arformoterol 15 mcg BID and placebo MDI
Salmeterol MDI 42 mcg BID and placebo inhalation solution
Placebo MDI and placebo inhalation solution