Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 657
Healthy volunteers: no

Brief summary:
This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.

Detailed description:
This was a randomized, blinded, double-dummy, parallel-group 12-week study to assess the efficacy, safety, and tolerability of NVA237 (50 μg o.d.) compared to tiotropium (18 μg o.d.) in patients with chronic obstructive pulmonary disease (COPD).

Arms:
arm 1: NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication. arm 2: Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.

Interventions: intervention 1: NVA237 intervention 2: Tiotropium intervention 3: Placebo to tiotropium intervention 4: Placebo to NVA237 intervention 5: salbutamol/albuterol
Intervention descriptions: intervention 1: NVA237 50 μg inhalation capsules once a day, delivered via SDDPI intervention 2: Tiotropium 18 μg once a day delivered via HandiHaler® device intervention 3: Placebo to tiotropium 18 μg o.d. once a day delivered via HandiHaler® device. intervention 4: Placebo to NVA237 50 μg once a day delivered via SDDPI intervention 5: salbutamol/albuterol given as a rescue medication via inhaler when needed

Protocol document: