Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, FEV1, indacaterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) arm 2: Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)

Interventions: intervention 1: Indacaterol intervention 2: Placebo
Intervention descriptions: intervention 1: Indacaterol 150µg capsules for inhalation daily intervention 2: Matching placebo indacaterol capsules for inhalation daily

Protocol document: