Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
NCT ID: NCT00250679
Last Updated: 2012-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
443 participants
INTERVENTIONAL
2005-10-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Formoterol 12 ųg 2x/day
Formoterol 12 ųg BID
Formoterol fumarate 12 ųg BID via aerolizer/DPI
Placebo
Placebo nebule or placebo aerolizer
Arformoterol 15 ųg 2x/day
Arformoterol tartrate inhalation solution
Arformoterol 15 ųg BID by nebulization
Placebo
Placebo nebule or placebo aerolizer
Arformoterol 25 ųg 2x/day
Arformoterol 25 ųg BID
Arformoterol 25 ųg BID by nebulization
Placebo
Placebo nebule or placebo aerolizer
Interventions
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Arformoterol tartrate inhalation solution
Arformoterol 15 ųg BID by nebulization
Arformoterol 25 ųg BID
Arformoterol 25 ųg BID by nebulization
Formoterol 12 ųg BID
Formoterol fumarate 12 ųg BID via aerolizer/DPI
Placebo
Placebo nebule or placebo aerolizer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD
* Subjects must have a \>=15 pack-year smoking history and a baseline breathlessness severity grade of \>=2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visits 1 and 2
* Female subjects \<=65 years of age must have a negative serum pregnancy test, females of childbearing potential must be using an acceptable method of birth control
* Subjects must be in general good health.
Exclusion Criteria
* Subjects with a blood eosinophil count \>5% of total white blood cell count
* Subjects have had a febrile illness within 72 hours (3 days) before Screening Visit 1
* Subjects with a chest x-ray that suggests a diagnosis other than COPD (e.g., diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions)
35 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sepracor Medical Director
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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Birmingham, Alabama, United States
Jasper, Alabama, United States
Mobile, Alabama, United States
Little Rock, Arkansas, United States
Carmichael, California, United States
Fullerton, California, United States
Long Beach, California, United States
Paramount, California, United States
Rancho Mirage, California, United States
San Diego, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Hartford, Connecticut, United States
Bay Pines, Florida, United States
Brandon, Florida, United States
Gainesville, Florida, United States
Panama City, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Normal, Illinois, United States
Evansville, Indiana, United States
Topeka, Kansas, United States
East Slidell, Louisiana, United States
Lafayette, Louisiana, United States
Metairie, Louisiana, United States
Sunset, Louisiana, United States
Baltimore, Maryland, United States
Chester, Maryland, United States
Wheaton, Maryland, United States
Ann Arbor, Michigan, United States
Saint Charles, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Statesville, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Lake Oswego, Oregon, United States
Medford, Oregon, United States
Pittsburgh, Pennsylvania, United States
Swarthmore, Pennsylvania, United States
East Providence, Rhode Island, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Simpsonville, South Carolina, United States
Spartanburg, South Carolina, United States
Union, South Carolina, United States
Knoxville, Tennessee, United States
Houston, Texas, United States
Katy, Texas, United States
San Antonio, Texas, United States
Danville, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Morgantown, West Virginia, United States
Countries
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References
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Hanania NA, Donohue JF, Nelson H, Sciarappa K, Goodwin E, Baumgartner RA, Hanrahan JP. The safety and efficacy of arformoterol and formoterol in COPD. COPD. 2010 Feb;7(1):17-31. doi: 10.3109/15412550903499498.
Other Identifiers
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091-061
Identifier Type: -
Identifier Source: org_study_id
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