Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD NVA FEV1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1324
Healthy volunteers: no

Brief summary:
A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms:
arm 1: Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication. arm 2: Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.

Interventions: intervention 1: Glycopyrronium bromide intervention 2: Placebo
Intervention descriptions: intervention 1: Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI) intervention 2: Placebo inhalation capsules were provided for use via a SDDPI

Protocol document: