Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects



Status:Archived
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2009
End Date:July 2012

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A Large Simple Safety Study of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease


This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice
daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation
will consist of a total of 6 visits over approximately 1 year.


This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group,
outpatient, safety study to evaluate the long-term safety of arformoterol 15 mcg twice daily
(BID) in the treatment of subjects with moderate-to-severe COPD. The administration of
arformoterol in subjects with moderate to severe COPD will not result in a meaningfully
greater incidence of respiratory death and COPD exacerbation -related hospitalizations
compared to placebo (nebulized saline and non-long-acting beta2-agonist [LABA] COPD standard
of care treatments). This study was previously posted by Sepracor Inc. In October 2009,
Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor
Inc's name was changed to Sunovion Pharmaceuticals Inc.


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175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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325 Winding River Lane
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434-817-2442
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304 Northeast 1st Street
Chiefland, Florida 32626
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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30 Pointe Circle
Greenville, South Carolina 29615
(864)255-3540
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
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500 Helendale Rd
Irondequoit, New York 14609
585-288-0890
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Anaheim, California 92801
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Ann Arbor, Michigan 48106
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Columbus, Georgia 31904
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1 Childrens Plaza
Dayton, Ohio 45404
(937) 641-3000
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Decatur, Georgia 30033
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
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Evansville, Indiana 47714
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Fullerton, California 92835
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Hazard, Kentucky 41701
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1 Baylor Plaza
Houston, Texas 77030
(713) 798-4951
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Jasper, Alabama 35501
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Minneapolis, Minnesota 55402
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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Newburgh, New York 12550
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Orlando, Florida 32806
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Spartanburg, South Carolina 29303
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St. Charles, Missouri 63301
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Tacoma, Washington 98405
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