A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

简要总结

主要结局

次要结局

• Trough FEV1 response(after 1, 4 and 8 weeks)
• Trough FVC response(after 1, 4, 8 and 12 weeks)
• FEV1 and FVC area under the curve (AUC)0-6h and peak response(after 0, 1, 4, 8 and 12 weeks)
• Individual FEV1 and FVC measurements(during 12 weeks)
• Onset and duration of therapeutic response and percentage of responders(after 0 and 12 weeks)
• Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)(up to 12 weeks)
• Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)(up to 12 weeks)
• COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)(up to 15 weeks)
• Physician's Global Evaluation(up to 15 weeks)
• Number of patients with at least one exacerbation of COPD(up to 15 weeks)
• Time to first exacerbation(up to 15 weeks)
• Number of exacerbations and exacerbation days(up to 15 weeks)