A Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for Four Weeks in Patients With Moderate Persistent Asthma

Exclusion Criteria

• •1. Patients with a significant disease other than asthma.A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
• •2. Patients with a clinically relevant abnormal screening hematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion no. 1.
• •3. Patients with a recent history (i.e. six months or less) of myocardial infarction.
• •4. Patients who have been hospitalised for cardiac failure during the past year.
• •5. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
• •6. Patients with lung diseases other than asthma (e.g. Chronic Obstructive Lung Disease (COPD)).
• •7. Patients with known active tuberculosis.
• •8. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
• •9. Patients who have undergone thoracotomy with pulmonary resection.
• •10. Patients with significant alcohol or drug abuse within the past two years.
• •11. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to V 1.
• •12. Patients with known hypersensitivity to anticholinergic drugs, Benzalconiumchloride (BAC), Ethylenediaminetetraacetate (EDTA) or any other components of the study medication delivery systems.
• •13. Pregnant or nursing women.
• •14. Women of childbearing potential not using a highly effective method of birth control.
• •15. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 or during the screening period. Topical cardio-selective beta-blocker eye medications for non-arrow angle glaucoma are allowed.
• •16. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 or during the screening period.
• •17. Patients who have been treated with oral beta-adrenergics within four weeks prior to Visit 1 or during the screening period.
• •18. Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 or during the screening period.
• •19. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 or during the screening period.20. Patients who have been treated with cromolyn sodium or nedocromil sodium within two weeks prior to Visit 1 or during the screening period.
• •21\. Patients who have been treated with methylxanthines within two weeks prior to Visit 1 or during the screening period.
• •22\. Patients who have taken an investigational drug within four weeks prior to Visit 1.
• •23\. Patients who have been treated with other non-approved and according to international guidelines not recommended "experimental" drugs for routine asthma therapy (e.g. TNFalpha blockers, methotrexate, cyclosporin) within four weeks prior to Visit 1 or during the screening period.
• •24\. Patients with any asthma exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 or during the screening period. Visit 1 and/or Visit 2 should be postponed in case of an asthma exacerbation or respiratory tract infection.
• •25\. Patients who have previously been randomised in this trial or are currently participating in another trial.
• •26.Patients who have been treated with depot corticosteroids within six months prior to Visit 1 or during the screening period.
• •27.Patients who have been treated with leukotriene modifiers within two weeks prior to Visit 1 or during the screening period.