Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium bromide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 614
Healthy volunteers: no

Brief summary:
This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

Detailed description:

Arms:
arm 1: QVA149 27.5/12.5 μg capsules arm 2: QVA149 27.5/25 μg capsules arm 3: QAB149 75 μg capsules

Interventions: intervention 1: QVA149 intervention 2: QVA149 intervention 3: QAB149 intervention 4: Placebo
Intervention descriptions: intervention 1: QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI intervention 2: QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI intervention 3: QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI intervention 4: To mimic QAB149

Protocol document: