Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

• ECG [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
• The key secondary objective will be to compare once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device is superior to twice daily treatment with Foradil Aerolizer using FEV1 AUC values. [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
• Additional endpoints of FEV1, FVC, FEV1 AUC [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
• Adverse Events [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]
• Vital Signs [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]
• Clinical Chemistry [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

• Drug: BI 1744 (Olodaterol) Low Dose
  BI1744 Respimat low dose once daily and placebo Foradil
• Drug: BI 1744 (Olodaterol) Medium Dose
  BI1744 Respimat medium dose once daily and placebo Foradil
• Drug: Placebo
  Placebo Respimat once daily and placebo Foradil
• Drug: Foradil
  12 mcg twice daily and placebo Respimat

• Experimental: BI1744 (Olodaterol)
  Medium Dose once Daily
  Intervention: Drug: BI 1744 (Olodaterol) Medium Dose
• Experimental: BI 1744 (Olodaterol)
  Low Dose once Daily
  Intervention: Drug: BI 1744 (Olodaterol) Low Dose
• Placebo Comparator: Placebo
  Placebo once Daily
  Intervention: Drug: Placebo
• Active Comparator: Foradil
  12 mcg twice daily
  Intervention: Drug: Foradil

Inclusion Criteria:

• Patients willing to participate with confirmed diagnosis of COPD
• 40 years of age or older
• having a 10 pack year smoking history
• able to perform serial pulmonary function tests
• able to use both a DPI and Respimat device

Exclusion Criteria:

Significant other disease

• clinically relevant abnormal hematology, chemistry, or urinalysis
• history of asthma
• diagnosis of thyrotoxicosis
• paroxysmal tachycardia related to beta agonists
• history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
• active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
• significant alcohol or drug use
• pulmonary resection
• taking oral beta adrenergics
• taking unstable oral steroids
• daytime oxygen
• enrolled in rehabilitation program
• enrolled in another study or taking investigational products
• pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
• those who are not willing to comply with pulmonary medication washouts