Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 36
Healthy volunteers: no

Brief summary:
Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.

Detailed description:

Arms:
arm 1: solution for inhalation arm 2: solution for inhalation arm 3: solution for inhalation arm 4: solution for inhalation arm 5: solution for inhalation arm 6: solution for inhalation

Interventions: intervention 1: single dose of 5 mcg intervention 2: single dose of placebo intervention 3: single dose of 40 mcg intervention 4: single dose of 20 mcg intervention 5: single dose of 2 mcg intervention 6: single dose of 10 mcg
Intervention descriptions: intervention 1: solution for inhalation intervention 2: solution for inhalation intervention 3: solution for inhalation intervention 4: solution for inhalation intervention 5: solution for inhalation intervention 6: solution for inhalation

Protocol document: