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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Indianapolis, Indiana 46202
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Anderson, South Carolina 29621
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Ann Arbor, Michigan 48109
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Biloxi, Mississippi 39531
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Birmingham, Alabama 35209
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Birmingham, Alabama 35209
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Boerne, Texas 78006
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Brooklyn, New York 11218
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Brooklyn, New York 11218
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Chattanooga, Tennessee 37404
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Chiefland, Florida 32626
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Cincinnati, Ohio 45229
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Cincinnati, Ohio 45229
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Clearwater, Florida 33756
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Columbia, Maryland 21044
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Columbus, Ohio 43205
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Columbus, Ohio 43205
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Dallas, Texas 75216
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Dallas, Texas 75216
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Dublin, Ohio 43016
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Edina, Minnesota 55435
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El Paso, Texas 79902
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Fountain Valley, California 92708
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Fridley, Minnesota 55432
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Fullerton, California 92835
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Great Neck, New York 11021
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Greenville, South Carolina 29605
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Hendersonville, North Carolina 28792
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Huntington Beach, California 92647
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Las Vegas, Nevada 89135
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Lynn Haven, Florida 32444
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Marion, Ohio 43302
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Medford, Oregon 97504
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Meridian, Idaho 83642
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Mesa, Arizona 85205
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Minneapolis, Minnesota 55402
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Montclair, California 91763
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Montgomery, Alabama 36109
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Newport News, Virginia 23606
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O'Fallon, Illinois 62269
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Omaha, Nebraska 68144
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Omaha, Nebraska 68144
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Orange, California 92868
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Orangevale, California 95662
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Papillion, Nebraska 68046
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Paramount, California 90723
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Phoenix, Arizona 85012
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, Pennsylvania 15224
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Richmond, Virginia 23249
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Richmond, Virginia 23249
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River Forest, Illinois 60305
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Riverside, California 92506
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Rochester, Minnesota 55905
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Rochester, Minnesota 55905
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Roseville, California 95661
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Sacramento, California 95825
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Sacramento, California 95825
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Sacramento, California 95825
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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San Diego, California 92123
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Savannah, Georgia 31406
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Seattle, Washington 98103
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South Burlington, Vermont 05403
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Spartanburg, South Carolina 29302
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St. Charles, Missouri 63301
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St. Louis, Missouri 63110
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Tacoma, Washington 98405
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Tipton, Pennsylvania 16684
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Torrance, California 90502
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Union, South Carolina 29379
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Vancouver, British Columbia
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Waltham, Massachusetts 02154
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Waterbury, Connecticut 06708
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Wheat Ridge, Colorado 80033
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