Conditions: Pulmonary Disease, Chronic Obstructive
Allocation:  | Intervention model: PARALLEL
Enrollment: 3991
Healthy volunteers: no

Brief summary:
The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

Detailed description:

Arms:
arm 1: Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded) arm 2: Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Interventions: intervention 1: Respimat intervention 2: Tiotropium
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: