Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:4/21/2016
Start Date:December 2009
End Date:June 2011

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A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose

The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium
bromide doses compared with placebo in the treatment of moderate to severe, stable chronic
obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in
period followed by a 12-week double-blind, placebo-controlled treatment period. This will be
followed by an open-label 40-week treatment period and a 2-week follow up phone call. All
patients will receive the higher Aclidinium Bromide during the 40-week open label treatment
period.


Inclusion Criteria:

- A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for
Chronic Obstructive Lung Disease (GOLD) guidelines, 2008; postbronchodilator FEV1/FVC
< 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted

- Current or former cigarette smokers

Exclusion Criteria:

- Patients who have been hospitalized for an acute COPD exacerbation within 3 months
before the first visit

- Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1

- Patient with any clinically significant respiratory conditions other than COPD,
cardiovascular conditions or mental illness

- History or presence of asthma verified from medical records

- Chronic use of oxygen therapy greater than or equal to 15 hours per day

- Patient with uncontrolled infection due to HIV and/or active hepatitis

- Patients with a history of hypersensitivity reaction to inhaled anticholinergics

- Patients with clinically significant cardiovascular conditions, including myocardial
infarction during the previous 6 months, newly diagnosed arrhythmia within the
previous 3 months, unstable angina, unstable arrhythmia that had required changes in
pharmacological therapy or other intervention.
We found this trial at
98
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High Point, North Carolina 27262
2291
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Abingdon, Virginia 24210
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Albuquerque, New Mexico 87109
1184
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Amarillo, Texas 79106
1358
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Anderson, Indiana 46011
1879
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Arlington, Texas 76012
1670
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Atlanta, Georgia 30328
2171
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Austin, Texas 78754
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Baltimore, Maryland 21285
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Bellevue, Nebraska 68123
1372
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Birmingham, Alabama 35216
2084
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Bowling Green, Kentucky 42101
1954
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Brockton, Massachusetts 02301
2495
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Calhoun, Georgia 30701
2121
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Charlotte, North Carolina 28204
2282
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Chelsea, Michigan 48118
1888
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Cincinnati, Ohio 45219
1966
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Clearwater, Florida 33765
2511
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Coeur d' Alene, Idaho 83814
259
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Collegeville, Pennsylvania 19426
2352
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Columbia, South Carolina 29204
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Columbus, Ohio 43213
2014
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Easley, South Carolina 29640
2216
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Edgewater, Florida 32132
2547
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Edina, Minnesota 55435
1389
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Elk Grove Village, Illinois 60007
1712
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Erie, Pennsylvania 16508
2076
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Evansville, Indiana 47712
1865
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Fall river, Massachusetts 02720
2502
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Fayetteville, Tennessee 37334
2021
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Feasterville, Pennsylvania 19053
2374
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Fremont, Nebraska 68025
1335
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Fridley, Minnesota 55432
1389
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Fullerton, California 92835
978
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Golden, Colorado 80401
1010
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Grenville, South Carolina 29615
2226
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Hazard, Kentucky 41701
2094
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Henderson, Nevada 89052
885
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Hollywood, Florida 33024
2721
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Homestead, Florida 33030
2734
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Houston, Texas 77008
1887
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Hurst, Texas 76054
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Indianapolis, Indiana 46202
1867
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Iowa City, Iowa 52240
1558
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Johnston, Rhode Island 02919
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Knoxville, Tennessee 37920
2110
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Larchmont, New York 10538
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Las Vegas, Nevada 89102
874
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Lawrenceville, Georgia 30046
2188
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Lincoln, Rhode Island 02865
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Livonia, Michigan 48152
1916
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Lynchburg, Virginia 24501
2277
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Medford, Oregon 97504
367
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Miami, Florida 33133
2731
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Minneapolis, Minnesota 55407
1391
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Missoula, Montana 59808
394
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Muscle Shoals, Alabama 35662
1988
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Naples, Florida 34119
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2099
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Norfolk, Virginia 23507
2429
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North Dartmouth, Massachusetts 02747
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North East, Maryland 21901
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North Syracuse, New York 13212
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O'Fallon, Illinois 62269
1735
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Oklahoma City, Oklahoma 73116
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Omaha, Nebraska 68131
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Paramount, California 90723
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Pell City, Alabama 35128
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Philadelphia, Pennsylvania 19139
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Phoenix, Arizona 85006
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Pittsburgh, Pennsylvania 15203
2134
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Plano, Texas 75001
1673
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Port Orange, Florida 32127
2536
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Pueblo, Colorado 81001
1102
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Richmond, Virginia 23230
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Rochester, Minnesota 55905
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Rolling Hill Estates, California 90274
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Sacramento, California 95817
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South Bend, Indiana 46617
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South Miami, Florida 33143
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Sunset, Louisiana 70584
1993
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Tacoma, Washington 98405
26
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Tipton, Pennsylvania 16684
2205
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Toledo, Ohio 43608
1930
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Tomball, Texas 77375
1863
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1456
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975
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Troy, Michigan 48085
1921
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Union, South Carolina 29379
2265
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119
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Vista, California 92083
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Winter Park, Florida 32789
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Zanesville, Ohio 43701
2055
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