| Company Name | Novartis (Taiwan) Co., Ltd. |
|---|---|
| Protocol Number | CQVA149A3405 |
| 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 | 4 |
| 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 | 2017 |
