Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 186
Healthy volunteers: no

Brief summary:
This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.

Detailed description:

Arms:
arm 1: Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. arm 2: Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.

Interventions: intervention 1: Indacaterol 300 µg intervention 2: Salmeterol 50 µg
Intervention descriptions: intervention 1: Indacaterol 300 µg once daily (od) via SDDPI intervention 2: Salmeterol 50 µg twice daily (bid) via Diskus®

Protocol document: