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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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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New Lambton, New South Wales
7456
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Albuquerque, New Mexico 87109
649
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Ann Arbor, Michigan 48106
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Anniston, Alabama 36207
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Arlington, Texas 76012
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Athens, Alabama 35611
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Atlanta, Georgia 30328
1917
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Austell, Georgia 30106
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Baltimore, Maryland 21285
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Bangor, Maine 04401
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Bay Pines, Florida 33744
2121
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Bellevue, Nebraska 68123
1300
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Bellingham, Washington 98225
1039
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Bend, Oregon 97701
712
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Birmingham, Alabama 35216
1787
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Boerne, Texas 78006
1166
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Bowling Green, Kentucky 42101
1778
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Bozeman, Montana 59718
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Brandon, Florida 33511
2146
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Brentwood, Tennessee 37027
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Buena Park, California 90620
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Cadiz, Ohio 43907
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Canton, Georgia 30114
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Canton, Ohio 44718
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Carrollton, Texas 75006
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Charleston, South Carolina 29407
2180
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Charlotte, North Carolina 28204
2102
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Cherry Hill, New Jersey 08002
2382
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Cincinnati, Ohio 45219
1879
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Clearwater, Florida 33765
2116
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Coeur d Alene, Idaho 83814
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Columbus, Ohio 43213
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Corsicana, Texas 75110
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Covington, Florida 70433
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Cumberland, Rhode Island 02864
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1223
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Downington, Pennsylvania 19335
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Eagle, Idaho 83616
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East Providence, Rhode Island 02914
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Edgewater, Florida 32132
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Edina, Minnesota 55435
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El Paso, Texas 79903
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Elizabeth City, North Carolina 27909
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Erie, Pennsylvania 16508
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Fall river, Massachusetts 02720
2576
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Fayetteville, Tennessee 37334
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Fort Lauderdale, Florida 33316
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Fort Mill, South Carolina 29707
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Fresno, California 93726
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Fridley, Minnesota 55432
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Gaffney, South Carolina 29340
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Great Neck, New York 11021
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Gulf Shores, Alabama 36542
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218
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High Point, North Carolina 27262
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Kansas City, Missouri 64111
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Kissimmee, Florida 34741
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Langhorne, Pennsylvania 19047
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Larchmont, New York 10538
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Lexington, Kentucky 40504
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Lincoln, California 95648
379
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Lincoln, Nebraska 68510
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Morgantown, West Virginia 26505
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N. Chesterfield, Missouri 63017
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N. Miami, Florida 33179
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Naples, Florida 34119
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New Orleans, Louisiana 70115
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New York, New York 10021
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Newport News, Virginia 23606
2324
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No. Dartmouth, Massachusetts 02747
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Norfolk, Virginia 23507
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Normal, Illinois 61761
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Oklahoma City, Oklahoma 73116
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Oldsmar, Florida 34677
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Olive Branch, Mississippi 38654
1600
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Omaha, Nebraska 68131
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Opelousas, Louisiana 70570
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