Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease, NVA 237, glycopyrronium, COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 773
Healthy volunteers: no

Brief summary:
This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.

Detailed description:

Arms:
arm 1: NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication. arm 2: Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication. arm 3: Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

Interventions: intervention 1: NVA237 50µg once daily intervention 2: Tiotropium 18µg once daily intervention 3: Flu/Sal intervention 4: NVA237 placebo + Tiotropium placebo.
Intervention descriptions: intervention 1: NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) intervention 2: Tiotropium 18 μg o.d. delivered via a proprietary inhalation device intervention 3: Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device intervention 4: Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Protocol document: