Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 198
Healthy volunteers: no

Brief summary:
The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.

Detailed description:

Arms:
arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: Very low dose inhaled orally once daily from the Respimat inhaler arm 3: Medium dose inhaled orally once daily from the Respimat inhaler arm 4: High dose inhaled orally once daily from the Respimat inhaler arm 5: 12mcg inhaled twice daily from the Aerolizer inhaler arm 6: 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: Placebo intervention 2: Olodaterol (BI 1744) high intervention 3: Olodaterol (BI 1744) medium intervention 4: Olodaterol (BI 1744) very low intervention 5: Formoterol 12 mcg intervention 6: Olodaterol (BI 1744) low
Intervention descriptions: intervention 1: Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler intervention 2: Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat intervention 3: Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat intervention 4: Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat intervention 5: Determine efficacy and safety of 12 mcg Formoterol dose inhaled orally twice daily from the Aerolizer in comparison to other treatment groups intervention 6: Determine efficacy and safety of 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat

Protocol document: