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
sites
Tipton, Pennsylvania 16684
2208
mi
from 91732
Tipton, PA
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Altamonte Springs, Florida 32701
2181
mi
from 91732
Altamonte Springs, FL
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Andalusia, Alabama 36420
1836
mi
from 91732
Andalusia, AL
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Anniston, Alabama 36207
1838
mi
from 91732
Anniston, AL
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Carrollton, Texas 75010
1214
mi
from 91732
Carrollton, TX
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Channelview, Texas 77530
1372
mi
from 91732
Channelview, TX
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Charlotte, North Carolina 28277
2104
mi
from 91732
Charlotte, NC
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Cincinnati, Ohio 45229
1881
mi
from 91732
Cincinnati, OH
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Colorado Springs, Colorado 80907
804
mi
from 91732
Colorado Springs, CO
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Columbia, Maryland 21044
2287
mi
from 91732
Columbia, MD
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Columbus, Ohio 43205
1962
mi
from 91732
Columbus, OH
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Columbus, Ohio 43205
1962
mi
from 91732
Columbus, OH
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Conyers, Georgia 30013
1941
mi
from 91732
Conyers, GA
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Cornelius, North Carolina 28031
2098
mi
from 91732
Cornelius, NC
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Deland, Florida 32720
2177
mi
from 91732
Deland, FL
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Dublin, Ohio 43016
1954
mi
from 91732
Dublin, OH
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Duluth, Georgia 30096
1930
mi
from 91732
Duluth, GA
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Edina, Minnesota 55435
1504
mi
from 91732
Edina, MN
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Fayetteville, Arkansas 72703
1352
mi
from 91732
Fayetteville, AR
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Fort Lauderdale, Florida 33313
2309
mi
from 91732
Fort Lauderdale, FL
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Fort Worth, Texas 76104
1195
mi
from 91732
Fort Worth, TX
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Fridley, Minnesota 55432
1512
mi
from 91732
Fridley, MN
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Gastonia, North Carolina 28054
2084
mi
from 91732
Gastonia, NC
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Henderson, Nevada 89014
216
mi
from 91732
Henderson, NV
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Hickory, North Carolina 28601
2068
mi
from 91732
Hickory, NC
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High Point, North Carolina 27262
2140
mi
from 91732
High Point, NC
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Huntersville, North Carolina 28078
2099
mi
from 91732
Huntersville, NC
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Huntington Beach, California 92647
24
mi
from 91732
Huntington Beach, CA
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Jasper, Alabama 35501
1754
mi
from 91732
Jasper, AL
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Kissimmee, Florida 34741
2187
mi
from 91732
Kissimmee, FL
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Lampasas, Texas 76550
1171
mi
from 91732
Lampasas, TX
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Marion, Ohio 43302
1955
mi
from 91732
Marion, OH
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McKinney, Texas 75069
1232
mi
from 91732
McKinney, TX
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Medford, Oregon 97504
628
mi
from 91732
Medford, OR
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Meridian, Idaho 83642
664
mi
from 91732
Meridian, ID
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Miami, Florida 33136
2321
mi
from 91732
Miami, FL
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Minneapolis, Minnesota 55402
1509
mi
from 91732
Minneapolis, MN
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Minneapolis, Minnesota 55402
1509
mi
from 91732
Minneapolis, MN
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3200 Northline Avenue
Multiple Locations, Alabama 27408
2149
mi
from 91732
Multiple Locations, AL
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8115 East 4th Avenue
Multiple Locations, Arizona 67501
1159
mi
from 91732
Multiple Locations, AZ
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New Braunfels, Texas 78130
1203
mi
from 91732
New Braunfels, TX
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New Orleans, Louisiana 70115
1655
mi
from 91732
New Orleans, LA
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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...
2435
mi
from 91732
New York, NY
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Newport News, Virginia 23606
2322
mi
from 91732
Newport News, VA
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Pensacola, Florida 32504
1810
mi
from 91732
Pensacola, FL
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Pensacola, Florida 32504
1810
mi
from 91732
Pensacola, FL
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Philadelphia, Pennsylvania 19102
2375
mi
from 91732
Philadelphia, PA
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Plymouth, Minnesota 55441
1502
mi
from 91732
Plymouth, MN
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Port Orange, Florida 32127
2194
mi
from 91732
Port Orange, FL
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
829
mi
from 91732
Portland, OR
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Rancho Mirage, California 92270
94
mi
from 91732
Rancho Mirage, CA
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Salt Lake City, Utah 84103
570
mi
from 91732
Salt Lake City, UT
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Slidell, Louisiana 70458
1666
mi
from 91732
Slidell, LA
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Sunset, Louisiana 70584
1532
mi
from 91732
Sunset, LA
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Tacoma, Washington 98405
939
mi
from 91732
Tacoma, WA
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Tempe, Arizona 85283
352
mi
from 91732
Tempe, AZ
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Tucson, Arizona 85745
417
mi
from 91732
Tucson, AZ
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Tucson, Arizona 85745
417
mi
from 91732
Tucson, AZ
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Winston-Salem, North Carolina 27157
2125
mi
from 91732
Winston-Salem, NC
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