Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD

Exclusion Criteria

• •1. Significant diseases other than COPD
• •2. Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
• •3. Patients with a recent history of myocardial infarction.
• •4. Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the past year.
• •5. Hospitalisation for cardiac failure during the past year.
• •6. Malignancy within the last five years excluded basal cell carcinoma.
• •7. Patients with a history of asthma or who have a total blood eosinophil count 600/mm3.
• •8. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
• •9. Known active tuberculosis.
• •10. Patients with a history of alcohol or drug abuse.
• •11. Thoracotomy with pulmonary resection.
• •12. Rehabilitation program within the last six weeks
• •13. Patients who regularly use daytime oxygen therapy
• •14. Patients who have taken an investigational drug within 30 days
• •15. Use of not allowed medications
• •16. Known hypersensitivity to used drugs or other components of the study medication.
• •17. Pregnant or nursing women
• •18. Women of childbearing potential not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. 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.
• •19. Patients who are currently participating in another study.