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
20
sites
Novartis Investigative Site
Cincinatti, Ohio 45219
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Cincinatti, OH
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Novartis Investigative Site
Abingdon, Virginia 24210
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Abingdon, VA
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Novartis Investigative site
Aurora, Colorado 80010
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Aurora, CO
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Novartis Investigative Site
Brick, New Jersey 08724
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Brick, NJ
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Novartis Investigative site
Dallas, Texas 75216
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Dallas, TX
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Novartis Investigative site
Gainesville, Georgia 30501
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Gainesville, GA
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Novartis Investigative Site
Hartford, Connecticut 06106
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Hartford, CT
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Novartis Investigative Site
High Point, North Carolina 27262
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High Point, NC
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Novartis Investigative Site
Kalispell, Montana 59901
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Kalispell, MT
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Novartis Investigative Site
Knoxville, Tennessee 37934
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Knoxville, TN
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Novartis Investigative Site
Las Vegas, Nevada 89135
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Las Vegas, NV
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Novartis Investigative site
Los Angeles, California 90095
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Los Angeles, CA
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Novartis Investigative Site
Miami, Florida 33136
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Miami, FL
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Novartis Investigative Site
Mt. Pleasant, South Carolina 29464
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Mt. Pleasant, SC
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Novartis Investigative Site
Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Novartis Investigative Site
Omaha, Nebraska 68144
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Omaha, NE
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Novartis Investigative Site
Phoenix, Arizona 85012
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Phoenix, AZ
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Novartis
Portland, Oregon 97228
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Portland, OR
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Novartis Investigative Site
Spokane, Washington 99202
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Spokane, WA
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Novartis Investigative Site
St Louis, Missouri 63104
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St Louis, MO
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