Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 360
Healthy volunteers: no

Brief summary:
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 micrograms tiotropium bromide solution for inhalation, delivered by the Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms:
arm 1: BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation arm 2: BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation arm 3: BI 1744 CL high dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation arm 4: tiotropium bromide; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation

Interventions: intervention 1: BI 1744 CL/tiotropium bromide fixed dose combination intervention 2: tiotropium bromide intervention 3: Respimat® Inhaler
Intervention descriptions: intervention 1: BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation intervention 2: tiotropium bromide; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation intervention 3: None

Protocol document: