Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD)

Inclusion Criteria:

1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior
to participation in the trial, which includes medication washout and restrictions

2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must
meet the following spirometric criteria:

Patients must have relatively stable airway obstruction with a post-bronchodilator
FEV1 greater or equal 30% of predicted normal and <80% of predicted normal and a
post-bronchodilator FEV1 / FVC <70% at Visit 1

3. Male or female patients, 40 years of age or older

4. Patients must be current or ex-smokers with a smoking history of more than 10 pack
years

5. Patients must be able to perform technically acceptable pulmonary function tests and
PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during
the study period as required in the protocol

6. Patients must be able to inhale medication in a competent manner from the Respimat
inhaler and from a metered dose inhaler (MDI).

Further inclusion criteria apply

Exclusion Criteria:

1. Patients with a significant disease other than COPD

2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or
urinalysis;

3. Patients with a history of asthma or a total blood eosinophil count >= 600/mm3.

4. Patients with any of the following conditions:a diagnosis of thyrotoxicosis, a
diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline
prolongation of QT/QTc interval (e.g. repeated demonstration of a QTcF* interval >
450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g.
heart failure, hypokalemia, family history of Long QT Syndrome)

5. Patients with any of the following conditions:a history of myocardial infarction
within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant
cardiac arrhythmia, known active tuberculosis, a malignancy for which patient has
undergone resection, radiation therapy or chemotherapy within last five years, a
history of life-threatening pulmonary obstruction, a history of cystic fibrosis,
clinically evident bronchiectasis, a history of significant alcohol or drug abuse

6. Patients who have undergone thoracotomy with pulmonary resection

7. Patients who regularly use daytime oxygen therapy for more than one hour per day and
in the investigator's opinion will be unable to abstain from the use of oxygen
therapy during clinic visits.

8. Pregnant or nursing women

9. Women of childbearing potential not using two effective method of birth control (one
barrier and one non-barrier). Female patients will be considered to be of
childbearing potential unless surgically sterilised by hysterectomy or bilateral
tubal ligation, or post-menopausal for at least two years

10. Patients who have previously been randomized in this study or are currently
participating in another study

11. Patients who are unable to comply with pulmonary medication restrictions prior to
randomization

12. Patients who have taken an investigational drug within one month or six half lives
(whichever is greater) prior to Screening Visit

Further exclusion criteria apply