A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With 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:November 2012
End Date:February 2014

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A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

This study will assess the efficacy, safety and tolerability of QVA149 in patients with
moderate to severe airflow limitation.

NOTE: Detailed Description: data not entered

Inclusion Criteria:

- Male and female patients that have signed informed consent and are >/= 40 years of
age.

- Patients with stable COPD according to GOLD 2011.

- Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted 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 or greater.

Exclusion Criteria:

- Patients with Type I or uncontrolled Type II diabetes - Patients with a history of
long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged
(>450 ms for males and females) and confirmed by a central assessor. (These patients
should not be re-screened.)

- Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102.
(These patients should not be re-screened.)

- Patients with a history of malignancy of any organ system, treated or untreated,
within the last five years.

- Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or
moderate-severe renal impairment or urinary retention.

- Patients who had a COPD exacerbation within 6 weeks prior to screening.

- Patients who have a respiratory tract infection within 4 weeks prior to screening.

- Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.

- Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms,
including COPD diagnosis, prior to age 40 years.

- Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.

- Patients with concomitant pulmonary disease.

- Patients with a diagnosis of alpha-1 anti-trypsin deficiency.

- Patients with active pulmonary tuberculosis.

- Patients in the active phase of a pulmonary rehabilitation programme.

- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
78
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Anderson, South Carolina 29621
2008
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Anderson, SC
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Ann Arbor, Michigan 48109
1932
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Ann Arbor, MI
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Biloxi, Mississippi 39531
1710
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Biloxi, MS
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Birmingham, Alabama 35209
1785
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Birmingham, AL
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Birmingham, Alabama 35209
1785
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Boerne, Texas 78006
1166
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Boerne, TX
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Brooklyn, New York 11218
2434
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Brooklyn, NY
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Brooklyn, New York 11218
2434
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Chattanooga, Tennessee 37404
1855
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Chiefland, Florida 32626
2078
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Cincinnati, Ohio 45229
1881
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Cincinnati, Ohio 45229
1881
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Cincinnati, OH
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Clearwater, Florida 33756
2117
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Clearwater, FL
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Columbia, Maryland 21044
2287
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Columbia, MD
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Columbus, Ohio 43205
1962
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Columbus, OH
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Columbus, Ohio 43205
1962
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Columbus, OH
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Dallas, Texas 75216
1225
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Dallas, TX
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Dallas, Texas 75216
1225
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Dallas, TX
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Dublin, Ohio 43016
1954
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Dublin, OH
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Edina, Minnesota 55435
1504
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Edina, MN
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El Paso, Texas 79902
685
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El Paso, TX
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Fountain Valley, California 92708
25
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Fountain Valley, CA
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Fridley, Minnesota 55432
1512
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Fullerton, California 92835
12
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Fullerton, CA
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Great Neck, New York 11021
2446
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Great Neck, NY
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Greenville, South Carolina 29605
2020
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Greenville, SC
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Hendersonville, North Carolina 28792
2010
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Hendersonville, NC
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Huntington Beach, California 92647
24
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Indianapolis, Indiana 46202
1792
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Indianapolis, IN
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Las Vegas, Nevada 89135
217
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Las Vegas, NV
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Lynn Haven, Florida 32444
1903
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Lynn Haven, FL
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Marion, Ohio 43302
1955
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Marion, OH
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Medford, Oregon 97504
628
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Medford, OR
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Meridian, Idaho 83642
664
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Meridian, ID
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Mesa, Arizona 85205
363
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Mesa, AZ
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Minneapolis, Minnesota 55402
1509
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Minneapolis, MN
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Montclair, California 91763
18
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Montgomery, Alabama 36109
1831
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Newport News, Virginia 23606
2322
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O'Fallon, Illinois 62269
1588
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Omaha, Nebraska 68144
1291
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Omaha, Nebraska 68144
1291
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Orange, California 92868
21
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Orangevale, California 95662
364
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Papillion, Nebraska 68046
1293
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Paramount, California 90723
15
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Phoenix, Arizona 85012
343
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Pittsburgh, Pennsylvania 15224
2121
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Pittsburgh, Pennsylvania 15224
2121
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Pittsburgh, Pennsylvania 15224
2121
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Pittsburgh, Pennsylvania 15224
2121
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Richmond, Virginia 23249
2267
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Richmond, Virginia 23249
2267
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River Forest, Illinois 60305
1720
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Riverside, California 92506
37
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Rochester, Minnesota 55905
1524
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Rochester, Minnesota 55905
1524
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Roseville, California 95661
369
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Sacramento, California 95825
364
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Sacramento, California 95825
364
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Sacramento, California 95825
364
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1187
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San Diego, California 92123
100
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San Diego, California 92123
100
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Savannah, Georgia 31406
2132
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Seattle, Washington 98103
965
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South Burlington, Vermont 05403
2469
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Spartanburg, South Carolina 29302
2043
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St. Charles, Missouri 63301
1557
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St. Louis, Missouri 63110
1570
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Tacoma, Washington 98405
939
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Tipton, Pennsylvania 16684
2208
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Torrance, California 90502
22
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Union, South Carolina 29379
2067
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Vancouver, British Columbia
1082
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Waltham, Massachusetts 02154
2569
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Waterbury, Connecticut 06708
2477
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Wheat Ridge, Colorado 80033
813
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