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

Use our guide to learn which trials are right for you!

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
Deland, Florida 32720
1124
mi
from
Deland, FL
Click here to add this to my saved trials
Altamonte Springs, Florida 32701
1136
mi
from
Altamonte Springs, FL
Click here to add this to my saved trials
Andalusia, Alabama 36420
783
mi
from
Andalusia, AL
Click here to add this to my saved trials
Anniston, Alabama 36207
728
mi
from
Anniston, AL
Click here to add this to my saved trials
Carrollton, Texas 75010
330
mi
from
Carrollton, TX
Click here to add this to my saved trials
Channelview, Texas 77530
572
mi
from
Channelview, TX
Click here to add this to my saved trials
Charlotte, North Carolina 28277
962
mi
from
Charlotte, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45229
727
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
386
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Maryland 21044
1134
mi
from
Columbia, MD
Click here to add this to my saved trials
Columbus, Ohio 43205
812
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43205
812
mi
from
Columbus, OH
Click here to add this to my saved trials
Conyers, Georgia 30013
823
mi
from
Conyers, GA
Click here to add this to my saved trials
Cornelius, North Carolina 28031
952
mi
from
Cornelius, NC
Click here to add this to my saved trials
Dublin, Ohio 43016
806
mi
from
Dublin, OH
Click here to add this to my saved trials
Duluth, Georgia 30096
807
mi
from
Duluth, GA
Click here to add this to my saved trials
Edina, Minnesota 55435
544
mi
from
Edina, MN
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
233
mi
from
Fayetteville, AR
Click here to add this to my saved trials
Fort Lauderdale, Florida 33313
1302
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
348
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fridley, Minnesota 55432
559
mi
from
Fridley, MN
Click here to add this to my saved trials
Gastonia, North Carolina 28054
940
mi
from
Gastonia, NC
Click here to add this to my saved trials
Henderson, Nevada 89014
957
mi
from
Henderson, NV
Click here to add this to my saved trials
Hickory, North Carolina 28601
921
mi
from
Hickory, NC
Click here to add this to my saved trials
High Point, North Carolina 27262
990
mi
from
High Point, NC
Click here to add this to my saved trials
Huntersville, North Carolina 28078
954
mi
from
Huntersville, NC
Click here to add this to my saved trials
Huntington Beach, California 92647
1162
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Jasper, Alabama 35501
649
mi
from
Jasper, AL
Click here to add this to my saved trials
Kissimmee, Florida 34741
1149
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Lampasas, Texas 76550
462
mi
from
Lampasas, TX
Click here to add this to my saved trials
Marion, Ohio 43302
810
mi
from
Marion, OH
Click here to add this to my saved trials
McKinney, Texas 75069
324
mi
from
McKinney, TX
Click here to add this to my saved trials
Medford, Oregon 97504
1357
mi
from
Medford, OR
Click here to add this to my saved trials
Meridian, Idaho 83642
1050
mi
from
Meridian, ID
Click here to add this to my saved trials
Miami, Florida 33136
1320
mi
from
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
551
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
551
mi
from
Minneapolis, MN
Click here to add this to my saved trials
3200 Northline Avenue
Multiple Locations, Alabama 27408
998
mi
from
Multiple Locations, AL
Click here to add this to my saved trials
8115 East 4th Avenue
Multiple Locations, Arizona 67501
21
mi
from
Multiple Locations, AZ
Click here to add this to my saved trials
New Braunfels, Texas 78130
556
mi
from
New Braunfels, TX
Click here to add this to my saved trials
New Orleans, Louisiana 70115
697
mi
from
New Orleans, LA
Click here to add this to my saved trials
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...
1290
mi
from
New York, NY
Click here to add this to my saved trials
Newport News, Virginia 23606
1167
mi
from
Newport News, VA
Click here to add this to my saved trials
Pensacola, Florida 32504
787
mi
from
Pensacola, FL
Click here to add this to my saved trials
Pensacola, Florida 32504
787
mi
from
Pensacola, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Plymouth, Minnesota 55441
550
mi
from
Plymouth, MN
Click here to add this to my saved trials
Port Orange, Florida 32127
1137
mi
from
Port Orange, FL
Click here to add this to my saved trials
Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1385
mi
from
Portland, OR
Click here to add this to my saved trials
Rancho Mirage, California 92270
1076
mi
from
Rancho Mirage, CA
Click here to add this to my saved trials
Salt Lake City, Utah 84103
779
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Slidell, Louisiana 70458
691
mi
from
Slidell, LA
Click here to add this to my saved trials
Sunset, Louisiana 70584
604
mi
from
Sunset, LA
Click here to add this to my saved trials
Tacoma, Washington 98405
1408
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tempe, Arizona 85283
847
mi
from
Tempe, AZ
Click here to add this to my saved trials
Tipton, Pennsylvania 16684
1061
mi
from
Tipton, PA
Click here to add this to my saved trials
Tucson, Arizona 85745
841
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tucson, Arizona 85745
841
mi
from
Tucson, AZ
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
974
mi
from
Winston-Salem, NC
Click here to add this to my saved trials