Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01572792
Last Updated: 2017-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
921 participants
INTERVENTIONAL
2012-04-30
2013-06-30
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
QUADRUPLE
Study Groups
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1
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day
2
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day
3
Aclidinium bromide 400 μg
Aclidinium bromide
Inhaled Aclidinium bromide 400 μg, twice per day
4
Formoterol Fumarate 12 μg
Formoterol Fumarate
Inhaled Formoterol Fumarate 12 μg, twice per day
5
Placebo
Placebo
Inhaled dose-matched placebo, twice per day
Interventions
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Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day
Aclidinium bromide
Inhaled Aclidinium bromide 400 μg, twice per day
Formoterol Fumarate
Inhaled Formoterol Fumarate 12 μg, twice per day
Placebo
Inhaled dose-matched placebo, twice per day
Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained from the patient before the initiation of any study specific procedures
* No medical contraindication as judged by the PI
* Compliance with LAC-MD-31 study procedures and IP dosing.
40 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 1827
Anniston, Alabama, United States
Forest Investigative Site 1920
Athens, Alabama, United States
Forest Investigative Site 1162
Birmingham, Alabama, United States
Forest Investigative Site 1493
Birmingham, Alabama, United States
Forest Investigative Site 1937
Birmingham, Alabama, United States
Forest Investigative Site 1824
Gulf Shores, Alabama, United States
Forest Investigative Site 2088
Jasper, Alabama, United States
Forest Investigative Site 1918
Scottsboro, Alabama, United States
Forest Investigative Site 0909
Glendale, Arizona, United States
Forest Investigative Site 1379
Phoenix, Arizona, United States
Forest Investigative Site 1822
Anaheim, California, United States
Forest Investigative Site 1483
Buena Park, California, United States
Forest Investigative Site 1156
Fresno, California, United States
Forest Investigative Site 1871
Lincoln, California, United States
Forest Investigative Site 1873
Los Angeles, California, United States
Forest Investigative Site 2064
Riverside, California, United States
Forest Investigative Site 1427
Sacramento, California, United States
Forest Investigative Site 1866
Sacramento, California, United States
Forest Investigative Site 1125
San Diego, California, United States
Forest Investigative Site 2009
San Diego, California, United States
Forest Investigative Site 1374
Torrance, California, United States
Forest Investigative Site 1813
Tustin, California, United States
Forest Investigative Site 1883
Vista, California, United States
Forest Investigative Site 1380
Golden, Colorado, United States
Forest Investigative Site 1137
Pueblo, Colorado, United States
Forest Investigative Site 1327
Wheat Ridge, Colorado, United States
Forest Investigative Site 1976
Waterbury, Connecticut, United States
Forest Investigative Site 1821
Bay Pines, Florida, United States
Forest Investigative Site 1154
Brandon, Florida, United States
Forest Investigative Site 1944
Brandon, Florida, United States
Forest Investigative Site 1364
Clearwater, Florida, United States
Forest Investigative Site 1152
Clearwater, Florida, United States
Forest Investigative Site 1875
Clearwater, Florida, United States
Forest Investigative Site 1811
Covington, Florida, United States
Forest Investigative Site 0670
DeLand, Florida, United States
Forest Investigative Site 1516
Edgewater, Florida, United States
Forest Investigative Site 0990
Fort Lauderdale, Florida, United States
Forest Investigative Site 1513
Hialeah, Florida, United States
Forest Investigative Site 1854
Hialeah, Florida, United States
Forest Investigative Site 1882
Hollywood, Florida, United States
Forest Investigative Site 1543
Jacksonville, Florida, United States
Forest Investigative Site 1416
Kissimmee, Florida, United States
Forest Investigative Site 1167
Melbourne, Florida, United States
Forest Investigative Site 1432
Miami, Florida, United States
Forest Investigative Site 1819
Naples, Florida, United States
Forest Investigative Site 1808
North Miami, Florida, United States
Forest Investigative Site 1950
Oldsmar, Florida, United States
Forest Investigative Site 1145
Ormond Beach, Florida, United States
Forest Investigative Site 1094
Panama City, Florida, United States
Forest Investigative Site 1803
Pembroke Pines, Florida, United States
Forest Investigative Site 0974
Pensacola, Florida, United States
Forest Investigative Site 1817
Sarasota, Florida, United States
Forest Investigative Site 1874
St. Petersburg, Florida, United States
Forest Investigative Site 2082
Tamarac, Florida, United States
Forest Investigative Site 2053
Tampa, Florida, United States
Forest Investigative Site 2047
Tampa, Florida, United States
Forest Investigative Site 1185
Winter Park, Florida, United States
Forest Investigative Site 1860
Winter Park, Florida, United States
Forest Investigative Site 1900
Atlanta, Georgia, United States
Forest Investigative Site 0987
Austell, Georgia, United States
Forest Investigative Site 1828
Canton, Georgia, United States
Forest Investigative Site 1830
Marietta, Georgia, United States
Forest Investigative Site 2089
Woodstock, Georgia, United States
Forest Investigative Site 0679
Coeur d'Alene, Idaho, United States
Forest Investigative Site 1858
Eagle, Idaho, United States
Forest Investigative Site 1095
Normal, Illinois, United States
Forest Investigative Site 1912
Normal, Illinois, United States
Forest Investigative Site 2051
River Forest, Illinois, United States
Forest Investigative Site 2033
Bowling Green, Kentucky, United States
Forest Investigative Site 2085
Fort Mitchell, Kentucky, United States
Forest Investigative Site 0539
Lexington, Kentucky, United States
Forest Investigative Site 1478
Louisville, Kentucky, United States
Forest Investigative Site 1519
Owensboro, Kentucky, United States
Forest Investigative Site 1430
New Orleans, Louisiana, United States
Forest Investigative Site 1812
Opelousas, Louisiana, United States
Forest Investigative Site 1814
Bangor, Maine, United States
Forest Investigative Site 1924
Baltimore, Maryland, United States
Forest Investigative Site 1872
Wheaton, Maryland, United States
Forest Investigative Site 1570
Fall River, Massachusetts, United States
Forest Investigative Site 1852
Fall River, Massachusetts, United States
Forest Investigative Site 1431
No. Dartmouth, Massachusetts, United States
Forest Investigative Site 1892
Ann Arbor, Michigan, United States
Forest Investigative Site 1342
Stevensville, Michigan, United States
Forest Investigative Site 1487
Troy, Michigan, United States
Forest Investigative Site 1128
Edina, Minnesota, United States
Forest Investigative Site 1527
Fridley, Minnesota, United States
Forest Investigative Site 2041
Minneapolis, Minnesota, United States
Forest Investigative Site 1124
Minneapolis, Minnesota, United States
Forest Investigative Site 1619
Plymouth, Minnesota, United States
Forest Investigative Site 1118
Rochester, Minnesota, United States
Forest Investigative Site 1884
Olive Branch, Mississippi, United States
Forest Investigative Site 1602
Kansas City, Missouri, United States
Forest Investigative Site 1587
N. Chesterfield, Missouri, United States
Forest Investigative Site 2079
Saint Charles, Missouri, United States
Forest Investigative Site 1856
Springfield, Missouri, United States
Forest Investigative Site 1867
Springfield, Missouri, United States
Forest Investigative Site 1399
St Louis, Missouri, United States
Forest Investigative Site 1599
St Louis, Missouri, United States
Forest Investigative Site 1831
Bozeman, Montana, United States
Forest Investigative Site 1400
Missoula, Montana, United States
Forest Investigative Site 1609
Bellevue, Nebraska, United States
Forest Investigative Site 1948
Fremont, Nebraska, United States
Forest Investigative Site 1815
Lincoln, Nebraska, United States
Forest Investigative Site 1363
Omaha, Nebraska, United States
Forest Investigative Site 1907
Omaha, Nebraska, United States
Forest Investigative Site 1911
Omaha, Nebraska, United States
Forest Investigative Site 1908
Omaha, Nebraska, United States
Forest Investigative Site 1804
Omaha, Nebraska, United States
Forest Investigative Site 1807
Henderson, Nevada, United States
Forest Investigative Site 1834
Las Vegas, Nevada, United States
Forest Investigative Site 1562
Las Vegas, Nevada, United States
Forest Investigative Site 1559
Cherry Hill, New Jersey, United States
Forest Investigative Site 1923
Hackensack, New Jersey, United States
Forest Investigative Site 1949
Albuquerque, New Mexico, United States
Forest Investigative Site 1151
Great Neck, New York, United States
Forest Investigative Site 1489
Larchmont, New York, United States
Forest Investigative Site 550
New York, New York, United States
Forest Investigative Site 1425
New York, New York, United States
Forest Investigative Site 2098
Rochester, New York, United States
Forest Investigative Site 1392
Charlotte, North Carolina, United States
Forest Investigative Site 2035
Elizabeth City, North Carolina, United States
Forest Investigative Site 1366
High Point, North Carolina, United States
Forest Investigative Site 1153
Raleigh, North Carolina, United States
Forest Investigative Site 1823
Salisbury, North Carolina, United States
Forest Investigative Site 1891
Cadiz, Ohio, United States
Forest Investigative Site 1134
Canton, Ohio, United States
Forest Investigative Site 1885
Cincinnati, Ohio, United States
Forest Investigative Site 1806
Cincinnati, Ohio, United States
Forest Investigative Site 2028
Cincinnati, Ohio, United States
Forest Investigative Site 1903
Cincinnati, Ohio, United States
Forest Investigative Site 1361
Columbus, Ohio, United States
Forest Investigative Site 1433
Columbus, Ohio, United States
Forest Investigative Site 2090
Sylvania, Ohio, United States
Forest Investigative Site 1530
Toledo, Ohio, United States
Forest Investigative Site 1393
Zanesville, Ohio, United States
Forest Investigative Site 1915
Oklahoma City, Oklahoma, United States
Forest Investigative Site 1889
Bend, Oregon, United States
Forest Investigative Site 2043
Medford, Oregon, United States
Forest Investigative Site 1833
Altoona, Pennsylvania, United States
Forest Investigative Site 1820
Downington, Pennsylvania, United States
Forest Investigative Site 1423
Erie, Pennsylvania, United States
Forest Investigative Site 1899
Langhorne, Pennsylvania, United States
Forest Investigative Site 1443
Philadelphia, Pennsylvania, United States
Forest Investigative Site 1863
Phoenixville, Pennsylvania, United States
Forest Investigative Site 1146
Pittsburgh, Pennsylvania, United States
Forest Investigative Site 1449
Tipton, Pennsylvania, United States
Forest Investigative Site 1862
Uniontown, Pennsylvania, United States
Forest Investigative Site 1832
Cumberland, Rhode Island, United States
Forest Investigative Site 1089
East Providence, Rhode Island, United States
Forest Investigative Site 2072
Charleston, South Carolina, United States
Forest Investigative Site 1905
Charleston, South Carolina, United States
Forest Investigative Site 1802
Charleston, South Carolina, United States
Forest Investigative Site 1914
Fort Mill, South Carolina, United States
Forest Investigative Site 1913
Gaffney, South Carolina, United States
Forest Investigative Site 1121
Spartanburg, South Carolina, United States
Forest Investigative Site 1957
Brentwood, Tennessee, United States
Forest Investigative Site 1526
Fayetteville, Tennessee, United States
Forest Investigative Site 1440
Arlington, Texas, United States
Forest Investigative Site 1879
Boerne, Texas, United States
Forest Investigative Site 1861
Carrollton, Texas, United States
Forest Investigative Site 1816
Corsicana, Texas, United States
Forest Investigative Site 1890
Dallas, Texas, United States
Forest Investigative Site 1332
El Paso, Texas, United States
Forest Investigative Site 2012
Fort Worth, Texas, United States
Forest Investigative Site 1951
Houston, Texas, United States
Forest Investigative Site 1091
McKinney, Texas, United States
Forest Investigative Site 1826
Plano, Texas, United States
Forest Investigative Site 1895
San Antonio, Texas, United States
Forest Investigative Site 1936
Salt Lake City, Utah, United States
Forest Investigative Site 1330
South Burlington, Vermont, United States
Forest Investigative Site 1945
Newport News, Virginia, United States
Forest Investigative Site 1404
Norfolk, Virginia, United States
Forest Investigative Site 1120
Bellingham, Washington, United States
Forest Investigative Site 1977
Spokane, Washington, United States
Forest Investigative Site 1878
Spokane, Washington, United States
Forest Investigative Site 1573
Spokane, Washington, United States
Forest Investigative Site 0988
Tacoma, Washington, United States
Forest Investigative Site 1870
Tacoma, Washington, United States
Forest Investigative Site 1555
Morgantown, West Virginia, United States
Forest Investigative Site 1991
New Lambton, New South Wales, Australia
Forest Investigative Site 1987
Redcliffe, Queensland, Australia
Forest Investigative Site 1973
Woolloongabba, Queensland, Australia
Forest Investigative Site 2253
Adelaide, South Australia, Australia
Forest Investigative Site 1981
Bedford Park, South Australia, Australia
Forest Investigative Site 1990
Daw Park, South Australia, Australia
Forest Investigative Site 2251
Toorak Gardens, South Australia, Australia
Forest Investigative Site 2250
Clayton, Victoria, Australia
Forest Investigative Site 1972
Fitzroy, Victoria, Australia
Forest Investigative Site 1986
Geelong, Victoria, Australia
Forest Investigative Site 1985
Parkville, Victoria, Australia
Forest Investigative Site 1904
Langley, British Columbia, Canada
Forest Investigative Site 905
Vancouver, British Columbia, Canada
Forest Investigative Site 0976
Winnipeg, Manitoba, Canada
Forest Investigative Site 1877
Sarina, Ontario, Canada
Forest Investigative Site 1896
Sarnia, Ontario, Canada
Forest Investigative Site 1171
Toronto, Ontario, Canada
Forest Investigative Site 2203
Toronto, Ontario, Canada
Forest Investigative Site 1952
Montreal, Quebec, Canada
Forest Investigative Site 1859
Québec, Quebec, Canada
Forest Investigative Site 0943
Saskatoon, Saskatchewan, Canada
Forest Investigative Site 1027
Auckland, , New Zealand
Forest Investigative Site 1970
Christchurch, , New Zealand
Forest Investigative Site 1967
Dunedin, , New Zealand
Forest Investigative Site 1964
Dunedin, , New Zealand
Forest Investigative Site 1968
Hamilton, , New Zealand
Forest Investigative Site 1965
Tauranga, , New Zealand
Forest Investigative Site 1980
Tauranga, , New Zealand
Forest Investigative Site 1025
Wellington, , New Zealand
Countries
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References
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D'Urzo A, Rennard S, Kerwin E, Donohue JF, Lei A, Molins E, Leselbaum A. A randomised double-blind, placebo-controlled, long-term extension study of the efficacy, safety and tolerability of fixed-dose combinations of aclidinium/formoterol or monotherapy in the treatment of chronic obstructive pulmonary disease. Respir Med. 2017 Apr;125:39-48. doi: 10.1016/j.rmed.2017.02.008. Epub 2017 Feb 16.
Related Links
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Other Identifiers
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LAC-MD-36
Identifier Type: -
Identifier Source: org_study_id
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