Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma

Inclusion criteria: * Diagnosis of COPD and diagnosis of asthma before the age of 30 * Current or ex-smokers with a cigarette smoking history of at least 10 pack-years * Treatment with inhaled steroids at least 1 year before study entry * FEV1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years * FEV1 increase of more than 200 mL 30 min. after 400 mcg salbutamol or documented increase of 200 mL after reversibility test within the last 5 years * Post bronchodilator FEV1 less than 80% predicted normal (ECCS) at visit 1 * Post bronchodilator FEV1 less than 70% of FVC at visit 1 Exclusion criteria: * Respiratory infection or exacerbation 6 weeks prior to Visit 1 or during run-in period. * Significant diseases other than COPD or asthma * Myocardial infarction within the last 6 months * Unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year * Hospitalisation for heart failure (NYHA Class III or IV) within the last year * History of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis * Known active tuberculosis * History of thoracotomy with pulmonary resection * History of cancer within the last 5 years (excluding treated basal cell carcinoma) * Patients requiring oxygen therapy for more than 1 hour per day * Patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before Visit 1 * Known hypersensitivity to anticholinergic drugs or lactose