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

A 12-week Randomised, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Efficacy and Safety of Inhaled Tiotropium 18μg q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma

The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a 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