A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:10/3/2013
Start Date:July 2013
End Date:March 2014
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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Trial Summary
Trial Overview
Inclusion Criteria

A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in COPD Patients With Moderate to Severe Airflow Limitation


Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in
patients with moderate to severe airflow limitation.


Inclusion Criteria: - Age >= 40 years, patients with airflow limitation indicated by
post-bronchdilation FEV1 >=30% and <80% of predicted normal, current or ex-smokers with a
10 pack year smoking history, patients with a mMRC grade 2 or greater Exclusion Criteria:
- prolonged QTCF >450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type II
diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments not
allowed in the study, other concomitant pulmonary diseases.

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
18
sites
Novartis Investigative Site
Miami, Florida 33136
2730
mi
from 98109
Miami, FL
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Novartis Investigative Site
Ann Arbor, Michigan 48109
1903
mi
from 98109
Ann Arbor, MI
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Novartis Investigative Site
Birmingham, Alabama 35294
2072
mi
from 98109
Birmingham, AL
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Novartis Investigative Site
Bismark, North Dakota 58501
1010
mi
from 98109
Bismark, ND
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Novartis Investigative site
Boston, Massachusetts 02118
2485
mi
from 98109
Boston, MA
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Novartis Investigative Site
Brick, New Jersey 08724
2417
mi
from 98109
Brick, NJ
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Novartis Investigative site
Dallas, Texas 75216
1684
mi
from 98109
Dallas, TX
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Novartis Investigative site
Gainesville, Georgia 30501
2181
mi
from 98109
Gainesville, GA
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Novartis Investigative Site
Iowa City, Iowa 52242
1558
mi
from 98109
Iowa City, IA
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Novartis Investigative site
Los Angeles, California 90095
979
mi
from 98109
Los Angeles, CA
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Novartis Investigative Site
Louisville, Kentucky 40202
1938
mi
from 98109
Louisville, KY
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Novartis Investigative Site
Mineola, New York 11501
2417
mi
from 98109
Mineola, NY
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Novartis Investigative Site
Mt. Pleasant, South Carolina 29464
2425
mi
from 98109
Mt. Pleasant, SC
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Novartis Investigative Site
New Orleans, Louisiana 70115
2099
mi
from 98109
New Orleans, LA
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Novartis Investigative Site
Omaha, Nebraska 68144
1359
mi
from 98109
Omaha, NE
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Novartis Investigative Site
Phoenix, Arizona 85012
1112
mi
from 98109
Phoenix, AZ
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Novartis Investigative Site
Rochester, Minnesota 55905
1450
mi
from 98109
Rochester, MN
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Novartis Investigative Site
Tupelo, Mississippi 38801
1962
mi
from 98109
Tupelo, MS
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