Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00706914
Last Updated: 2017-05-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
156 participants
INTERVENTIONAL
2008-06-30
2008-11-11
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
DOUBLE
Study Groups
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Once-daily aclidinium/formoterol
Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening
Once-daily aclidinium/formoterol
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Placebo to formoterol fumarate
Inhaled placebo to formoterol fumarate once-daily in the evening
Morning aclidinium/formoterol plus evening formoterol
Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening
Once-daily aclidinium/formoterol
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Once-daily formoterol fumarate
Inhaled formoterol fumarate 12 μg once-daily in the evening
Formoterol BID
Formoterol fumarate 12 µg twice-daily (BID)
Twice-daily formoterol fumarate
Inhaled formoterol fumarate 12 µg twice-daily (BID)
Interventions
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Once-daily aclidinium/formoterol
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Twice-daily formoterol fumarate
Inhaled formoterol fumarate 12 µg twice-daily (BID)
Placebo to formoterol fumarate
Inhaled placebo to formoterol fumarate once-daily in the evening
Once-daily formoterol fumarate
Inhaled formoterol fumarate 12 μg once-daily in the evening
Eligibility Criteria
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Inclusion Criteria
* Smoking history of greater or equal to 10 pack-years
* Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines
* Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive
* Postbronchodilator FEV1/FVC ratio \< 0.70
Exclusion Criteria
* Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry
* Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
* Eosinophil count of at least 600 cells/mm3
* Long term oxygen therapy \> 15 hours a day
40 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Esther Garcia, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Forest Investigative Site
Tucson, Arizona, United States
Forest Investigative Site
Tucson, Arizona, United States
Forest Investigative Site
Fullerton, California, United States
Forest Investigative Site
Lakewood, California, United States
Forest Investigative Site
Rancho Mirage, California, United States
Forest Investigative Site
Redlands, California, United States
Forest Investigative Site
San Diego, California, United States
Forest Investigative Site
San Jose, California, United States
Forest Investigative Site
Stockton, California, United States
Forest Investigative Site
Wheat Ridge, Colorado, United States
Forest Investigative Site
Hartford, Connecticut, United States
Forest Investigative Site
New Britain, Connecticut, United States
Forest Investigative Site
Waterbury, Connecticut, United States
Forest Investigative Site
DeLand, Florida, United States
Forest Investigative Site
Panama City, Florida, United States
Forest Investigative Site
Tamarac, Florida, United States
Forest Investigative Site
Tampa, Florida, United States
Forest Investigative Site
Atlanta, Georgia, United States
Forest Investigative Site
Austell, Georgia, United States
Forest Investigative Site
Blue Ridge, Georgia, United States
Forest Investigative Site
Bowling Green, Kentucky, United States
Forest Investigative Site
Hazard, Kentucky, United States
Forest Investigative Site
North Dartmouth, Massachusetts, United States
Forest Investigative Site
Rochester, Minnesota, United States
Forest Investigative Site
Florissant, Missouri, United States
Forest Investigative Site
Saint Charles, Missouri, United States
Forest Investigative Site
St Louis, Missouri, United States
Forest Investigative Site
Albany, New York, United States
Forest Investigative Site
Charlotte, North Carolina, United States
Forest Investigative Site
Cincinnati, Ohio, United States
Forest Investigative Site
Columbus, Ohio, United States
Forest Investigative Site
Medford, Oregon, United States
Forest Investigative Site
Pittsburgh, Pennsylvania, United States
Forest Investigative Site
East Providence, Rhode Island, United States
Forest Investigative Site
Spartanburg, South Carolina, United States
Forest Investigative Site
Dallas, Texas, United States
Forest Investigative Site
McKinney, Texas, United States
Forest Investigative Site
Midvale, Utah, United States
Forest Investigative Site
Richmond, Virginia, United States
Forest Investigative Site
Milwaukee, Wisconsin, United States
Countries
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Related Links
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Other Identifiers
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LAC-MD-24
Identifier Type: -
Identifier Source: org_study_id
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