Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 152
Healthy volunteers: no

Brief summary:
The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.

Detailed description:

Arms:
arm 1: Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication. arm 2: Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.

Interventions: intervention 1: NVA237 intervention 2: Tiotropium intervention 3: Placebo to NVA237 intervention 4: Placebo to tiotropium intervention 5: Salbutamol
Intervention descriptions: intervention 1: NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI) intervention 2: Tiotropium 18 μg once daily delivered via HandiHaler® device. intervention 3: Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI). intervention 4: Placebo to tiotropium once daily delivered via HandiHaler® device intervention 5: Used as resuce medication

Protocol document: