A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)

You may be eligible if

• participation in the trial 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
• ? Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 =\< 70% of predicted normal\* and FEV1 =\< 70% of FVC (Visits 1 and 2).
• \*: Predicted normal values will be calculated according to the formulas for Japanese predicted normal values (R05-0607) (see below).
• Males: FEV1 predicted (L) = 0.036 x (height (cm)) ? 0.028 x age (years) ? 1.178 Females: FEV1 predicted (L) = 0.022 x (height (cm)) ? 0.022 x age (years) ? 0.005
• ? Patients must maintain stable COPD medications for 1 month prior to 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.
• Pack Years = \[Number of cigarettes/ day / 20\] x years of smoking 5. Patients must be able to perform technically acceptable pulmonary function tests.
• 6\. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and the HandiHaler.
• Patients with/who:
• 1. Significant diseases except COPD
• 2. Clinically relevant abnormal haematology, blood chemistry, or urinalysis
• 3. Recent history of MI
• 4. Any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past 3 yrs
• 5. Cancer within the last 5 yrs
• 6. Symptomatic prostatic hypertrophy or bladder neck obstruction
• 7. Narrow-angle glaucoma
• 8. History of asthma, allergic rhinitis, atopic disease, or who have a total blood eosinophil count \>= 600 mm3
• 9. History of life-threatening pulmonary obstruction, or cystic fibrosis or clinically evident bronchiectasis
• 10. Active tuberculosis
• 11. History of and/or active significant alcohol or drug abuse
• 12. Underwent thoracotomy with pulmonary resection
• 13. Completed a pulmonary rehabilitation program within the 6 weeks prior to the Scr. Visit or who are currently in a pulmonary rehabilitation program
• 14. Regularly use daytime oxygen for more than 1 h/day and in the investigator?s opinion unable to abstain from the use of oxygen
• 15. Took an investigational drug within 1 m or 6 half lives prior to Scr. Visit
• 16. Beta-blockers
• 17. Anti-allergic drugs or antihistamines for asthma, allergic rhinitis, atopic disease, or other allergic disease with a total blood eosinophil count \>= 600 mm3
• 18. Oral corticosteroids at unstable doses or at doses in excess of the equivalent of 10 mg of prednisone/day or 20 mg every other day
• 19. Hypersensitivity to anticholinergic drugs, or components of the Respimat delivery system, to lactose or any other component of the inhalation capsule deliver system
• 20. Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women
• 21. Who are currently participating in another study
• 22. The randomisation of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Scr. Visit or during the scr. period should be postponed