Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD

Exclusion Criteria

• •1. a significant disease other than chronic obstructive pulmonary disease (COPD). (review contraindications for exercise testing),
• •2. a recent history of myocardial infarction within one year.
• •3. a recent history of heart failure, pulmonary oedema, or patients with cardiac arrhythmia or any contraindication to exercise described in the CTProtocol within the last 3.
• •4. daytime supplemental oxygen.
• •5. a diagnosis of known active tuberculosis.
• •6. a history of cancer within the last 5 years.
• •7. a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
• •8. thoracotomy with pulmonary resection.
• •9. an upper respiratory tract infection or an exacerbation of chronic obstructive pulmonary disease (COPD)
• •10. a known hypersensitivity to anticholinergic drug, ß-adrenergic or corticosteroids, lactose or any other component of the inhalation capsule delivery system.
• •11. a known symptomatic prostatic hypertrophy or bladder neck obstruction.
• •12. a known moderate or severe renal insufficiency.
• •13. a known narrow-angle glaucoma.
• •14. a known untreated hypokalemia.
• •15. a known untreated thyrotoxicosis.
• •16. a history of asthma, allergic rhinitis or atopy, or a total blood eosinophil count larger than 600/mm3.
• •17. treatment with cromolyn sodium or nedocromil sodium
• •18. treatment with antihistamines or antileukotrienes.
• •19. treatment with tiotropium for 1 month before Visit 1.
• •20. treatment with oral corticosteroid medication.
• •21. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
• •22. a history of or active alcohol or drug abuse.
• •23. an investigational drug within 1 month or 10 half lives
• •24. a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea.
• •25. participation in a rehabilitation program for chronic obstructive pulmonary disease (COPD).
• •26. treatment with monoamine oxidase inhibitors inhibitors or tricyclic antidepressants.
• •27. participation in another study.
• •28. more than eight puffs of salbutamol/day during the run-in period