This study compared the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B. This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus: 1. Indacaterol 150ug or 2. Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough FEV1) was assessed after 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Indacaterol 150µg capsules for inhalation daily
Matching placebo indacaterol capsules for inhalation daily
Novartis Investigative Site
Hong Kong, Hong Kong
Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
To compare the effects of indacaterol 150ug once dialy (od) to placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing.
Time frame: at week 12
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