A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i

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)
• Therapeutic response and percentage of responders(after 0 and 12 weeks)
• Weekly mean pre-dose morning and evening PEFR(during study course of 12 weeks)
• Number of occasions of rescue therapy used per day (PRN salbutamol)(during study course of 12 weeks)
• Physician's Global Evaluation(during 15 weeks)
• time to first exacerbation(15 weeks)
• number of exacerbations(15 weeks)
• number of exacerbation days(15 weeks)
• Patient satisfaction and preference(12 weeks)
• FEV1 and FVC area under the curve and peak response(after 0, 1, 4, 8 and 12 weeks)
• Individual FEV1 and FVC measurements at each time point(during study course of 12 weeks)
• Number of patients with at least one exacerbation of COPD(15 weeks)
• COPD symptom scores(during 15 weeks)
• All adverse events(during 15 weeks, follow-up period included)
• Pulse rate and blood pressure for the first three hours following dosing(after 0, 1, 4, 8 and 12 weeks)
• Routine blood chemistry, haematology and urinalysis(after 12 weeks)
• 12-lead ECG(after 12 weeks)
• Physical examination(after 12 weeks)