Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA149 indacaterol NVA237 COPD fluticasone/salmeterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 523
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Detailed description:

Arms:
arm 1: Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. arm 2: Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Interventions: intervention 1: indacaterol and glycopyrronium (QVA149) intervention 2: Placebo to fluticasone/salmeterol intervention 3: fluticasone/salmeterol intervention 4: Placebo to indacaterol and glycopyrronium (QVA149)
Intervention descriptions: intervention 1: QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily. intervention 2: Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily. intervention 3: Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily. intervention 4: Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily

Protocol document: