Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease COPD QVA149 QAB149 NVA237 indacaterol glycopyrronium bromide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 193
Healthy volunteers: no

Brief summary:
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description:
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).

Arms:
arm 1: QVA149 plus placebo once daily for 28 days. arm 2: Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.

Interventions: intervention 1: QVA149 intervention 2: NVA237 intervention 3: QAB149 intervention 4: Placebo
Intervention descriptions: intervention 1: QVA149 110/50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily intervention 2: NVA237 50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily intervention 3: QAB149 150 ug supplied as capsules in blister packs for inhalation via SDDPI , once daily intervention 4: Placebo capsules provided in blister packs for inhalation via SDDPI, once daily

Protocol document: