Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Multicenter, Open-Label, Randomized, Active-Controlled, Parallel Group Chronic Safety Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
Verified date | February 2012 |
Source | Sunovion |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD
Status | Completed |
Enrollment | 799 |
Est. completion date | December 2004 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Lovelace Scientific Resources - NM | Albuquerque | New Mexico |
United States | Northeast Clinical Research Center, Inc. | Allentown | Pennsylvania |
United States | ClinSite, Inc. | Ann Arbor | Michigan |
United States | Pinnacle Research Group | Anniston | Alabama |
United States | New Horizon Health Research | Atlanta | Georgia |
United States | Protocare Trial, Inc. | Austell | Georgia |
United States | Primary Care Cardiology Research, Inc. | Ayer | Massachusetts |
United States | Office of Paul A. Shapero, MD, PA | Bangor | Maine |
United States | Princeton Pulmonary Group, PC | Birmingham | Alabama |
United States | Office of Keith Popovich, MD | Butte | Montana |
United States | Charlotte Lung and Health Center | Charlotte | North Carolina |
United States | Medsource, Inc. | Chesapeake | Virginia |
United States | University of Chicago - Department of Medicine | Chicago | Illinois |
United States | Community Research Management Associates, Inc. | Cincinnati | Ohio |
United States | New Horizons Clinical Research, Inc. | Cincinnati | Ohio |
United States | Clinical Research of West Florida, Inc. | Clearwater | Florida |
United States | Pulmonary Consultants | Coeur d'Alene | Idaho |
United States | nTouch Research | Decatur | Georgia |
United States | University Clinical Research, DeLand | DeLand | Florida |
United States | Safe Harbor Clinical Research | East Providence | Rhode Island |
United States | Endwell Family Physicians | Endwell | New York |
United States | Medisphere Medical Research Center, LLC | Evansville | Indiana |
United States | Northern California Research Corp. | Fair Oaks | California |
United States | Odyssey Research Services | Fargo | North Dakota |
United States | Pulmonary Associates of Fredericksburg, Inc. | Fredericksburg | Virginia |
United States | SARC Research Center | Fresno | California |
United States | Northern Colorado Pulmonary Consultants, PC | Ft. Collins | Colorado |
United States | Ben Taub General Hospital | Houston | Texas |
United States | Breath of Life Research Institute | Houston | Texas |
United States | S.W. Asthma Institute | Houston | Texas |
United States | Irvine Center for Clinical Research | Irvine | California |
United States | Asthma & Allergy Associates, PC | Ithaca | New York |
United States | Pulmonary & Sleep Associates of Jasper, PC | Jasper | Alabama |
United States | Volunteer Research Group | Knoxville | Tennessee |
United States | Bendel Medical Associates | Lafayette | Louisiana |
United States | Scripps Clinic - Chest and Critical Care | LaJolla | California |
United States | Advanced Biomedical Research of America | Las Vegas | Nevada |
United States | Clinical Research Center of Nevada | Las Vegas | Nevada |
United States | Torrance Clinical Research | Los Angeles | California |
United States | Atlantic Research Associates, Inc. | Margate City | New Jersey |
United States | Marietta Pulmonary Medicine | Marietta | Georgia |
United States | Clinical Research Institute of Southern Oregon, PC | Medford | Oregon |
United States | Medford Medical Clinic, LLP | Medford | Oregon |
United States | nTouch Research | Melbourne | Florida |
United States | Minnesota Lung Center | Minneapolis | Minnesota |
United States | Facey Medical Center - Radiant Research | Mission Hills | California |
United States | Montana Medical Research, LLC | Missoula | Montana |
United States | Pulmonary Associates of Mobile, P.C. | Mobile | Alabama |
United States | Morgantown Pulmonary Associates | Morgantown | West Virginia |
United States | Office of Delmer Henninger, MD | Murrieta | California |
United States | New Orleans Center for Clinical Research | New Orleans | Louisiana |
United States | N.Y. Pulmonary Associates | New York City | New York |
United States | Sneeze, Wheeze and Itch, LLC | Normal | Illinois |
United States | COR Clinical Research LLC | Oklahoma City | Oklahoma |
United States | Advanced Clinical Research Institute | Orange | California |
United States | Center for Clinical Trials, LLC | Paramount | California |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Allergy Associates Research Center | Portland | Oregon |
United States | North Carolina Clinical Research | Raleigh | North Carolina |
United States | Advances in Medicine | Rancho Mirage | California |
United States | Commonwealth Clinical Research | Richmond | Virginia |
United States | Pulmonary Associates of Richmond, Inc. | Richmond | Virginia |
United States | Virginia Adult & Pediatric Allergy & Asthma, PC Research Office | Richmond | Virginia |
United States | Consortium Clinical Research, Ltd. | Ridley Park | Pennsylvania |
United States | Inland Clinical Research, Inc. | Riverside | California |
United States | Ridgewood Medical Group | Rochester | New York |
United States | North Point Pulmonary Associates | Roswell | Georgia |
United States | MedEx HealthCare Research, Inc. | Saint Louis | Missouri |
United States | Wellmed at Northern Hills | San Antonio | Texas |
United States | Institute of Healthcare Assessment, Inc. | San Diego | California |
United States | Wetlin Research Associates, Inc. | San Diego | California |
United States | San Jose Clinical Research, Inc. | San Jose | California |
United States | Heart of America Research Institute | Shawnee Mission | Kansas |
United States | West Coast Clinical Trials | Signal Hill | California |
United States | North Shore Research Associates | Slidell | Louisiana |
United States | South Bend Clinic | South Bend | Indiana |
United States | Pulmonary Research Partners, Inc. | South Boston | Virginia |
United States | UrgentMed Family Practice Medical | South Bound Brook | New Jersey |
United States | Spartanburg Pharmaceutical Research | Spartanburg | South Carolina |
United States | Midwest Chest Consultants, PC | St. Charles | Missouri |
United States | C.A.R.E Clinical Research | St. Louis, | Missouri |
United States | nTouch Research | St. Petersburg | Florida |
United States | Pulmonary Consultants, PLLC | Tacoma | Washington |
United States | AHS Medical Research, Inc. | Tampa | Florida |
United States | USF Asthma, Allergy and Immunology | Tampa | Florida |
United States | Center for Clinical Research | Taunton | Massachusetts |
United States | Arizona Clinical Research Center, Inc. | Tucson | Arizona |
United States | Healthcare Research Consultants | Tulsa | Oklahoma |
United States | Allergy & Asthma Medical Group of Diablo Valley, Inc. | Walnut Creek | California |
United States | New Hanover Medical Research | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Sunovion |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall occurrence of adverse events | Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 | Yes | |
Secondary | Laboratory parameters | Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 | Yes | |
Secondary | ECG parameters | Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 | Yes | |
Secondary | 24-hour holter monitoring parameters | Weeks -1, 0, 13, 26, 39, 52 | Yes | |
Secondary | Vital signs | Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 | Yes | |
Secondary | Plasma arformoterol concentrations | Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52 | No | |
Secondary | Physical examination findings | Weeks -1, 53 | No |
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