Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma

Exclusion Criteria

• •1. Significant disease other than asthma.
• •2. Abnormal haematology or blood chemistry.
• •3. History of heart disease, and/or hospitalised for cardiac syncope or failure.
• •4. Any unstable or life-threatening or requiring intervention or cardiac arrhythmia.
• •5. Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy.
• •6. Active tuberculosis.
• •7. Alcohol or drug abuse.
• •8. Thoracotomy with pulmonary resection.
• •9. Pulmonary rehabilitation program.
• •10. Hypersensitivity to anticholinergic drugs, or any components of the study medication delivery system.
• •11. Pregnant or nursing adolescent female patients.
• •12. Female patients of child-bearing potential not using a highly effective method of birth control.
• •13. Investigational drug within four weeks or six half lives prior to Visit 1.
• •14. Long-acting anticholinergics within four weeks prior to Visit 1.
• •15. Systemic corticosteroids at a high dose or at a not stable low dose within four weeks prior to Visit 1.
• •16. Leukotriene modifiers if not stabilised for at least four weeks prior to Visit 1.
• •17. Long-acting theophylline preparations if not stabilised for at least two weeks prior to Visit 1.
• •18. Anti Immunoglobulin E (Anti-IgE) treatment if not stabilised for at least six months prior to Visit 1.
• •19. Cromones if not stabilised within four weeks prior to Visit 1.
• •20. Oral beta-blocker medication within four weeks prior to Visit 1.
• •21. Systemic oral or i.v. or s.c. beta-adrenergics within four weeks prior to Visit 1.
• •22. Other non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1.
• •23. Any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.
• •24. Randomised in this trial or currently participating in another trial.
• •25. Narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
• •26. Moderate to severe renal impairment.
• •27. Patients requiring 10 or more puffs of rescue medication per day on more than 2 consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.