Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD Japanese Phase 3 Safety OT Oxis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 251
Healthy volunteers: no

Brief summary:
This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 240 patients with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120 patients on standard COPD therapy).

Detailed description:

Arms:
arm 1: Formoterol 9 μg/dose

Interventions: intervention 1: Formoterol (OT)
Intervention descriptions: intervention 1: 9 μg/dose, Inhaled, twice daily for 52 weeks

Protocol document: