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
sites
Fullerton, California 92835
1154
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Fullerton, CA
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Anderson, South Carolina 29621
874
mi
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Anderson, SC
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Ann Arbor, Michigan 48109
808
mi
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Ann Arbor, MI
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Biloxi, Mississippi 39531
716
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Biloxi, MS
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Birmingham, Alabama 35209
685
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Birmingham, AL
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Birmingham, Alabama 35209
685
mi
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Birmingham, AL
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Boerne, Texas 78006
552
mi
from
Boerne, TX
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Brooklyn, New York 11218
1288
mi
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Brooklyn, NY
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Brooklyn, New York 11218
1288
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Brooklyn, NY
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Chattanooga, Tennessee 37404
721
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Chattanooga, TN
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Chiefland, Florida 32626
1031
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Chiefland, FL
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Cincinnati, Ohio 45229
727
mi
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Cincinnati, OH
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Cincinnati, Ohio 45229
727
mi
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Cincinnati, OH
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Clearwater, Florida 33756
1102
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Clearwater, FL
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Columbia, Maryland 21044
1134
mi
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Columbia, MD
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Columbus, Ohio 43205
812
mi
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Columbus, OH
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Columbus, Ohio 43205
812
mi
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Columbus, OH
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Dallas, Texas 75216
353
mi
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Dallas, TX
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Dallas, Texas 75216
353
mi
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Dallas, TX
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Dublin, Ohio 43016
806
mi
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Dublin, OH
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Edina, Minnesota 55435
544
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Edina, MN
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El Paso, Texas 79902
641
mi
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El Paso, TX
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Fountain Valley, California 92708
1160
mi
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Fountain Valley, CA
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Fridley, Minnesota 55432
559
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Fridley, MN
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Great Neck, New York 11021
1301
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Great Neck, NY
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Greenville, South Carolina 29605
883
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Greenville, SC
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Hendersonville, North Carolina 28792
868
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Hendersonville, NC
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Huntington Beach, California 92647
1162
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Huntington Beach, CA
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Indianapolis, Indiana 46202
642
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Indianapolis, IN
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Las Vegas, Nevada 89135
960
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Las Vegas, NV
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Lynn Haven, Florida 32444
867
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Lynn Haven, FL
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Marion, Ohio 43302
810
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Marion, OH
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Medford, Oregon 97504
1357
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Medford, OR
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Meridian, Idaho 83642
1050
mi
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Meridian, ID
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Mesa, Arizona 85205
835
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Mesa, AZ
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Minneapolis, Minnesota 55402
551
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Minneapolis, MN
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Montclair, California 91763
1137
mi
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Montclair, CA
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Montgomery, Alabama 36109
751
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Montgomery, AL
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Newport News, Virginia 23606
1167
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Newport News, VA
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O'Fallon, Illinois 62269
433
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O'Fallon, IL
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Omaha, Nebraska 68144
257
mi
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Omaha, NE
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Omaha, Nebraska 68144
257
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Omaha, NE
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Orange, California 92868
1153
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Orange, CA
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Orangevale, California 95662
1268
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Orangevale, CA
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Papillion, Nebraska 68046
253
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Papillion, NE
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Paramount, California 90723
1167
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Paramount, CA
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Phoenix, Arizona 85012
851
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15224
974
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Pittsburgh, PA
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Pittsburgh, Pennsylvania 15224
974
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Pittsburgh, PA
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Pittsburgh, Pennsylvania 15224
974
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Pittsburgh, PA
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Pittsburgh, Pennsylvania 15224
974
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Pittsburgh, PA
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Richmond, Virginia 23249
1111
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Richmond, VA
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Richmond, Virginia 23249
1111
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Richmond, VA
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River Forest, Illinois 60305
602
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River Forest, IL
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Riverside, California 92506
1123
mi
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Riverside, CA
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Rochester, Minnesota 55905
515
mi
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Rochester, MN
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Rochester, Minnesota 55905
515
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Rochester, MN
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Roseville, California 95661
1269
mi
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Roseville, CA
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Sacramento, California 95825
1278
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Sacramento, CA
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Sacramento, California 95825
1278
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Sacramento, CA
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Sacramento, California 95825
1278
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Sacramento, CA
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
576
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San Antonio, TX
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San Diego, California 92123
1138
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San Diego, CA
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San Diego, California 92123
1138
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San Diego, CA
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Savannah, Georgia 31406
1026
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Savannah, GA
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Seattle, Washington 98103
1412
mi
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Seattle, WA
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South Burlington, Vermont 05403
1357
mi
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South Burlington, VT
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Spartanburg, South Carolina 29302
903
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Spartanburg, SC
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St. Charles, Missouri 63301
403
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St. Charles, MO
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St. Louis, Missouri 63110
415
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Tacoma, Washington 98405
1408
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Tacoma, WA
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Tipton, Pennsylvania 16684
1061
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Tipton, PA
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Torrance, California 90502
1176
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Torrance, CA
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Union, South Carolina 29379
929
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Union, SC
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Vancouver, British Columbia
1486
mi
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Vancouver,
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Waltham, Massachusetts 02154
1435
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Waltham, MA
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Waterbury, Connecticut 06708
1337
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Waterbury, CT
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Wheat Ridge, Colorado 80033
416
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Wheat Ridge, CO
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