A Randomized, Multiple-dose, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Study to Determine the Optimum Dose of BEA 2180 BR Delivered by the Respimat® Inhaler 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 and 2 weeks(after 1 and 2 weeks)
• Trough FVC response after 1, 2 and 4 weeks(after 1, 2 and 4 weeks)
• FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks(after 0, 1, 2 and 4 weeks)
• Individual FEV1 and FVC measurements at each time point(4 weeks)
• Weekly mean pre-dose morning and evening PEFR(4 weeks)
• Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol](4 weeks)
• COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)(4 weeks)
• Physician's Global Evaluation(4 weeks)
• All adverse events(7 weeks)
• Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT)(4 weeks)
• 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5)(4 weeks)
• drug plasma concentrations(4 or 7 weeks)
• drug urine concentrations(4 or 7 weeks)