PMS Registry
Company Name
Novartis (Taiwan) Co., Ltd.
Protocol Number
Title of Study
A 12-week treatment, multi-center, randomized, double-blind, double-dummy, parallel group study to assess the efficacy and safety of switching from salmeterol/fluticasone to QVA149 (indacaterol maleate/glycopyrronium bromide) in symptomatic COPD patients
Primary Objective
To demonstrate superiority of QVA149 110/50 µg o.d. compared to salmeterol/fluticasone 50/500 µg b.i.d. in trough pre-dose FEV1 at week 12
Number of Sites
Period of Study
From:July 1, 2015 to:June 30, 2017
Number of Patients
20/472 (Taiwan/Other countries)人
IRB Approval Date
May 21, 2015
Publication Plan / Date