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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tiotropium Bromide

Criteria

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