A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation



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:October 2012
End Date:June 2014

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This study is to assess the safety and tolerability of two different doses of QVA149 and
QAB149 in patients with moderate to severe airflow limitation.


Inclusion Criteria:

- Male and female adults aged ≥40 years

- Patients with stable COPD according to GOLD strategy (GOLD 2011).

- Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and
<80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70.

- Current or ex-smokers who have a smoking history of at least 10 pack years.

- Patients with an mMRC ≥ grade 2

Exclusion Criteria:

- History of long QT syndrome or prolonged QTc

- Patients who have had a COPD exacerbation that required treatment with antibiotics
and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit
1.

- Patients with Type I or uncontrolled Type II diabetes

- Patients with a history of asthma or have concomitant pulmonary disease

- Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with
persistent atrial fibrillation and controlled with a rate control strategy for at
least six months could be eligible

- Patients who have clinically significant renal, cardiovascular, neurological,
endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological
abnormalities which could interfere with the assessment of safety

- Other protocol defined inclusion/exclusion criteria may apply
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Boulder, Colorado 80304
1174
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Abingdon, Virginia 24210
230
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Ames, Iowa 50010
570
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Baltimore, Maryland 21287
345
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Bangor, Maine 04401
798
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Bowling Green, Kentucky 42101
278
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Corsicana, Texas 75110
925
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Dayton, Ohio 45402
64
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Dublin, Ohio 43016
10
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Eugene, Oregon 97401
2055
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Evansville, Indiana 47713
280
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Ft. Worth, Texas 76104
937
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Henderson, Nevada 89014
1754
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Henderson, Nevada 89014
1754
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Honolulu, Hawaii 96813
4501
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Huntington Beach, California 92647
1968
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Iowa City, Iowa 52240
459
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Iowa City, IA
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Jackson, Mississippi 39209
660
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Jackson, MS
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Knoxville, Tennessee 37934
280
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Lakewood, California 90712
1972
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Las Vegas, Nevada 89135
1756
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Lincoln, Nebraska 68506
718
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Livonia, Michigan 48152
171
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Lombard, Illinois 60148
291
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Los Angeles, California 90095
1982
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Lufkin, Texas 75904
885
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McKinney, Texas 75069
885
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Medford, Oregon 97504
2060
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Midlothian, Virginia 23114
335
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Minneapolis, Minnesota 55402
625
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Minneapolis, Minnesota 55402
625
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Missoula, Montana 59808
1614
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New Orleans, Louisiana 70115
798
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Newport News, Virginia 23606
404
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O'Fallon, Illinois 62269
380
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Oklahoma City, Oklahoma 73104
848
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Oklahoma City, Oklahoma 73104
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Omaha, Nebraska 68144
691
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Orange, California 92868
1958
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Peoria, Illinois 61615
352
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Picayune, Mississippi 39466
752
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Slidell, Louisiana 70458
770
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Spartanburg, South Carolina 29302
351
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St. Charles, Missouri 63301
407
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Stockton, California 95204
2046
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Vestavia, Alabama 35216
497
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Walnut Creek, California 94598
2086
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Waterloo, Iowa 50702
512
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