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)



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:6/10/2016
Start Date:April 2012
End Date:June 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase III, Long-term, Randomized, Double-blind, Extension Study of the 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)

The purpose of this Phase III study is to evaluate the long-term safety and tolerability of
two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium
bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic
Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and
health-related quality of life assessments will also be evaluated. This extension study will
include a 28 week treatment period, followed by a four week follow up visit. All patients
will remain in the same treatment group as for the lead-in study and continue on one of the
four treatment arms or placebo.


Inclusion Criteria:

- Completion of the treatment phase of the lead-in study, LAC-MD-31

- 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.

Exclusion Criteria:

- No specific exclusion criteria
We found this trial at
150
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Forest Investigative Site 1819
Naples, Florida 34119
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Albuquerque, New Mexico 87109
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Forest Investigative Site 1833
Altoona, Pennsylvania 16601
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Forest Investigative Site 1822
Anaheim, California 92801
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Forest Investigative Site 1892
Ann Arbor, Michigan 48106
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Forest Investigative Site 1827
Anniston, Alabama 36207
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Forest Investigative Site 1440
Arlington, Texas 76012
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Forest Investigative Site 1920
Athens, Alabama 35611
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Atlanta, Georgia 30328
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Forest Investigative Site 0987
Austell, Georgia 30106
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Baltimore, Maryland 21285
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Forest Investigative Site 1814
Bangor, Maine 04401
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Forest Investigative Site 1821
Bay Pines, Florida 33744
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Forest Investigative Site 1609
Bellevue, Nebraska 68123
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Forest Investigative Site 1120
Bellingham, Washington 98225
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Forest Investigative Site 1889
Bend, Oregon 97701
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Forest Investigative Site 010
Birmingham, Alabama 35216
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Forest Investigative Site 1879
Boerne, Texas 78006
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Forest Investigative Site 2033
Bowling Green, Kentucky 42101
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Forest Investigative Site 1831
Bozeman, Montana 59718
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Forest Investigative site 056
Brandon, Florida 33511
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Forest Investigative Site 1957
Brentwood, Tennessee 37027
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Forest Investigative site 038
Buena Park, California 90620
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Forest Investigative Site 1891
Cadiz, Ohio 43907
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Forest Investigative Site 1828
Canton, Georgia 30114
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Canton, GA
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Forest Investigative Site 036
Canton, Ohio 44718
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Forest Investigative site 025
Carrollton, Texas 75006
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Forest Investigative site 066
Charleston, South Carolina 29407
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Forest Investigative site 034
Charlotte, North Carolina 28204
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Charlotte, NC
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Forest Investigative Site 023
Cherry Hill, New Jersey 08002
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Cherry Hill, NJ
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Forest Investigative Site 005
Cincinnati, Ohio 45219
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Cincinnati, OH
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Forest Investigative Site 1152
Clearwater, Florida 33765
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Forest Investigative Site 0679
Coeur d Alene, Idaho 83814
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Forest Investigative site 084
Columbus, Ohio 43213
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Forest Investigative Site 1816
Corsicana, Texas 75110
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Forest Investigative Site 1811
Covington, Florida 70433
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Forest Investigative Site 1832
Cumberland, Rhode Island 02864
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Dallas, Texas 75230
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Forest Investigative Site 0670
DeLand, Florida 32720
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Forest Investigative Site 1820
Downington, Pennsylvania 19335
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Forest Investigative Site 1858
Eagle, Idaho 83616
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Forest Investigative Site 1089
East Providence, Rhode Island 02914
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Forest Investigative Site 1516
Edgewater, Florida 32132
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Edgewater, FL
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Forest Investigative Site 1128
Edina, Minnesota 55435
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Edina, MN
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Forest Investigative Site 1332
El Paso, Texas 79903
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Forest Investigative Site 2035
Elizabeth City, North Carolina 27909
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Forest Investigative Site 1423
Erie, Pennsylvania 16508
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Forest Investigative Site 1852
Fall river, Massachusetts 02720
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Forest Investigative site 052
Fayetteville, Tennessee 37334
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Forest Investigative site 017
Fort Lauderdale, Florida 33316
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Forest Investigative Site 1914
Fort Mill, South Carolina 29707
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Forest Investigative Site 2085
Fort Mitchell, Kentucky 41017
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Forest Investigative Site 2012
Fort Worth, Texas 76104
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Forest Investigative Site 1948
Fremont, Nebraska 68025
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Forest Investigative site 064
Fresno, California 93726
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Forest Investigative Site 1527
Fridley, Minnesota 55432
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Forest Investigative Site 1913
Gaffney, South Carolina 29340
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Forest Investigative Site 0909
Glendale, Arizona 85306
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Forest Investigative Site 1380
Golden, Colorado 80401
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Forest Investigative Site 1151
Great Neck, New York 11021
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Forest Investigative Site 1824
Gulf Shores, Alabama 36542
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Forest Investigative Site 1923
Hackensack, New Jersey 07601
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Forest Investigative Site 1807
Henderson, Nevada 89052
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Forest Investigative Site 1854
Hialeah, Florida 33012
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Forest Investigative Site 1366
High Point, North Carolina 27262
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Forest Investigative Site 1882
Hollywood, Florida 33024
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Houston, Texas 77008
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Forest Investigative Site 1543
Jacksonville, Florida 32216
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Forest Investigative Site 2088
Jasper, Alabama 35501
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Forest Investigative Site 1782
Kansas City, Missouri 64111
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Kissimmee, Florida 34741
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Forest Investigative Site 1899
Langhorne, Pennsylvania 19047
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Larchmont, New York 10538
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Forest Investigative Site 012
Las Vegas, Nevada 89102
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Forest Investigative Site 0539
Lexington, Kentucky 40504
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Forest Investigative Site 1871
Lincoln, California 95648
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Lincoln, Nebraska 68510
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Forest Investigative site 049
Los Angeles, California 90057
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Forest Investigative site 087
Louisville, Kentucky 40213
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Forest Investigative Site 1830
Marietta, Georgia 30066
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Forest Investigative Site 1091
Mckinney, Texas 75069
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Forest Investigative Site 2043
Medford, Oregon 97504
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Forest Investigative Site 1167
Melbourne, Florida 32935
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Forest Investigative site 067
Miami, Florida 33133
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Forest Investigative Site 1124
Minneapolis, Minnesota 55407
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Forest Investigative Site 1400
Missoula, Montana 59808
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Forest Investigative Site 1555
Morgantown, West Virginia 26505
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Forest Investigative Site 1587
N. Chesterfield, Missouri 63017
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Forest Investigative Site 1808
N. Miami, Florida 33179
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Forest Investigative Site 1991
New Lambton, New South Wales
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Forest Investigative site 030
New Orleans, Louisiana 70115
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New York, New York 10021
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Forest Investigative Site 1945
Newport News, Virginia 23606
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Forest Investigative Site 1431
No. Dartmouth, Massachusetts 02747
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Forest Investigative site 031
Norfolk, Virginia 23507
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Forest Investigative Site 1912
Normal, Illinois 61761
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Oklahoma City, Oklahoma 73116
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Forest Investigative Site 1950
Oldsmar, Florida 34677
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Olive Branch, Mississippi 38654
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Omaha, Nebraska 68131
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Opelousas, Louisiana 70570
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