Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 906
Healthy volunteers: no

Brief summary:
The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.

Detailed description:

Arms:
arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: High dose inhaled orally once daily from the Respimat inhaler arm 3: 12mcg inhaled twice daily from the Aerolizer inhaler arm 4: Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler

Interventions: intervention 1: Olodaterol (BI 1744) intervention 2: Olodaterol (BI 1744) intervention 3: Formoterol intervention 4: Placebo intervention 5: Placebo
Intervention descriptions: intervention 1: Comparison of low and high doses on efficacy and safety in COPD patients intervention 2: Comparison of low and high doses on efficacy and safety in COPD patients intervention 3: Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients intervention 4: Placebo for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients intervention 5: Placebo for comparison Formoterolon safety and efficacy in COPD patients

Protocol document: