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

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

sites

Novartis Investigative site

Gainesville, Georgia 30501

from

Gainesville, GA