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
Marion, Ohio 43302
1982
mi
from 98109
Marion, OH
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Altamonte Springs, Florida 32701
2541
mi
from 98109
Altamonte Springs, FL
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Andalusia, Alabama 36420
2192
mi
from 98109
Andalusia, AL
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Anniston, Alabama 36207
2117
mi
from 98109
Anniston, AL
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Carrollton, Texas 75010
1663
mi
from 98109
Carrollton, TX
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Channelview, Texas 77530
1899
mi
from 98109
Channelview, TX
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Charlotte, North Carolina 28277
2289
mi
from 98109
Charlotte, NC
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Cincinnati, Ohio 45229
1966
mi
from 98109
Cincinnati, OH
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Colorado Springs, Colorado 80907
1065
mi
from 98109
Colorado Springs, CO
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Columbia, Maryland 21044
2318
mi
from 98109
Columbia, MD
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Columbus, Ohio 43205
2010
mi
from 98109
Columbus, OH
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Columbus, Ohio 43205
2010
mi
from 98109
Columbus, OH
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Conyers, Georgia 30013
2199
mi
from 98109
Conyers, GA
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Cornelius, North Carolina 28031
2270
mi
from 98109
Cornelius, NC
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Deland, Florida 32720
2527
mi
from 98109
Deland, FL
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Dublin, Ohio 43016
1998
mi
from 98109
Dublin, OH
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Duluth, Georgia 30096
2179
mi
from 98109
Duluth, GA
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Edina, Minnesota 55435
1390
mi
from 98109
Edina, MN
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Fayetteville, Arkansas 72703
1643
mi
from 98109
Fayetteville, AR
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Fort Lauderdale, Florida 33313
2712
mi
from 98109
Fort Lauderdale, FL
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Fort Worth, Texas 76104
1662
mi
from 98109
Fort Worth, TX
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Fridley, Minnesota 55432
1389
mi
from 98109
Fridley, MN
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Gastonia, North Carolina 28054
2266
mi
from 98109
Gastonia, NC
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Henderson, Nevada 89014
882
mi
from 98109
Henderson, NV
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Hickory, North Carolina 28601
2238
mi
from 98109
Hickory, NC
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High Point, North Carolina 27262
2290
mi
from 98109
High Point, NC
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Huntersville, North Carolina 28078
2274
mi
from 98109
Huntersville, NC
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Huntington Beach, California 92647
987
mi
from 98109
Huntington Beach, CA
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Jasper, Alabama 35501
2044
mi
from 98109
Jasper, AL
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Kissimmee, Florida 34741
2556
mi
from 98109
Kissimmee, FL
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Lampasas, Texas 76550
1712
mi
from 98109
Lampasas, TX
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McKinney, Texas 75069
1670
mi
from 98109
McKinney, TX
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Medford, Oregon 97504
367
mi
from 98109
Medford, OR
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Meridian, Idaho 83642
399
mi
from 98109
Meridian, ID
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Miami, Florida 33136
2730
mi
from 98109
Miami, FL
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Minneapolis, Minnesota 55402
1391
mi
from 98109
Minneapolis, MN
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Minneapolis, Minnesota 55402
1391
mi
from 98109
Minneapolis, MN
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3200 Northline Avenue
Multiple Locations, Alabama 27408
2294
mi
from 98109
Multiple Locations, AL
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8115 East 4th Avenue
Multiple Locations, Arizona 67501
1399
mi
from 98109
Multiple Locations, AZ
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New Braunfels, Texas 78130
1786
mi
from 98109
New Braunfels, TX
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New Orleans, Louisiana 70115
2099
mi
from 98109
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...
2400
mi
from 98109
New York, NY
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Newport News, Virginia 23606
2412
mi
from 98109
Newport News, VA
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Pensacola, Florida 32504
2198
mi
from 98109
Pensacola, FL
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Pensacola, Florida 32504
2198
mi
from 98109
Pensacola, FL
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Philadelphia, Pennsylvania 19102
2373
mi
from 98109
Philadelphia, PA
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Plymouth, Minnesota 55441
1381
mi
from 98109
Plymouth, MN
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Port Orange, Florida 32127
2538
mi
from 98109
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...
146
mi
from 98109
Portland, OR
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Rancho Mirage, California 92270
1008
mi
from 98109
Rancho Mirage, CA
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Salt Lake City, Utah 84103
701
mi
from 98109
Salt Lake City, UT
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Slidell, Louisiana 70458
2096
mi
from 98109
Slidell, LA
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Sunset, Louisiana 70584
1993
mi
from 98109
Sunset, LA
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Tacoma, Washington 98405
27
mi
from 98109
Tacoma, WA
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Tempe, Arizona 85283
1124
mi
from 98109
Tempe, AZ
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Tipton, Pennsylvania 16684
2205
mi
from 98109
Tipton, PA
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Tucson, Arizona 85745
1214
mi
from 98109
Tucson, AZ
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Tucson, Arizona 85745
1214
mi
from 98109
Tucson, AZ
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Winston-Salem, North Carolina 27157
2274
mi
from 98109
Winston-Salem, NC
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