Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tiotropium Bromide

Criteria

Inclusion Criteria:

• Diagnosis of COPD

• FEV1 < 60% predicted

• FEV1 < 70% of FVC

• Smoking history of 10 pack-years

Exclusion Criteria:

• Significant other disease than COPD

• Recent history of MI (1 year or less)

• Cardiac arrhythmia requiring drug therapy

• History of asthma, allergic rhinitis or eosinophil count > 600 mm3

• Symptomatic prostatic hypertrophy or bladder neck obstruction

• Known narrow-angle glaucoma

• Abnormal baseline hematology, blood chemistry or urinalysis

• History of cancer within last 5 years

• Life-threatening pulmonary obstruction

• Cystic fibrosis or bronchiectasis

• Tuberculosis

• Pulmonary resection