Efficacy and Safety Study of QVA149 in COPD Patients



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:12/27/2017
Start Date:July 28, 2015
End Date:September 12, 2016

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A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, 2-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation

The purpose of this study is to demonstrate that the efficacy of the combination product
QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a
pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.


Inclusion Criteria:

- Male or female adults aged ≥40 yrs

- Smoking history of at least 10 pack years

- Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the
Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)

- Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the
predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

- Modified Medical Research Council questionnaire grade of 2 or higher

Exclusion Criteria:

- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1

- Patients with concomitant pulmonary disease

- Patients with a history of asthma

- Any patient with lung cancer or a history of lung cancer

- Patients with a history of certain cardiovascular co-morbid conditions

- Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

- Patients in the active phase of a supervised pulmonary rehabilitation program

- Patients contraindicated for inhaled anticholinergic agents and β2 agonists

- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
59
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Fayetteville, Arkansas 72703
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Altamonte Springs, Florida 32701
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Andalusia, Alabama 36420
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Anniston, Alabama 36207
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Carrollton, Texas 75010
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Channelview, Texas 77530
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Charlotte, North Carolina 28277
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Cincinnati, Ohio 45229
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Colorado Springs, Colorado 80907
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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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Conyers, Georgia 30013
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Conyers, GA
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Cornelius, North Carolina 28031
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Cornelius, NC
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Deland, Florida 32720
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Dublin, Ohio 43016
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Dublin, OH
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Duluth, Georgia 30096
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Edina, Minnesota 55435
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Fort Lauderdale, Florida 33313
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Fort Worth, Texas 76104
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Fridley, Minnesota 55432
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Gastonia, North Carolina 28054
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Henderson, Nevada 89014
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Hickory, North Carolina 28601
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High Point, North Carolina 27262
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Huntersville, North Carolina 28078
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Huntington Beach, California 92647
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Jasper, Alabama 35501
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Kissimmee, Florida 34741
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Lampasas, Texas 76550
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Marion, Ohio 43302
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McKinney, Texas 75069
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Medford, Oregon 97504
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Meridian, Idaho 83642
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Miami, Florida 33136
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Minneapolis, Minnesota 55402
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Minneapolis, Minnesota 55402
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3200 Northline Avenue
Multiple Locations, Alabama 27408
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Multiple Locations, AL
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8115 East 4th Avenue
Multiple Locations, Arizona 67501
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New Braunfels, Texas 78130
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New Orleans, Louisiana 70115
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Newport News, Virginia 23606
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Pensacola, Florida 32504
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Pensacola, Florida 32504
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Plymouth, Minnesota 55441
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Port Orange, Florida 32127
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Portland, Oregon 97228
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Rancho Mirage, California 92270
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Salt Lake City, Utah 84103
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Slidell, Louisiana 70458
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Sunset, Louisiana 70584
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Tacoma, Washington 98405
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Tempe, Arizona 85283
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Tipton, Pennsylvania 16684
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Tucson, Arizona 85745
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Tucson, Arizona 85745
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Winston-Salem, North Carolina 27157
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