A 12-week Randomised, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Efficacy and Safety of Inhaled Tiotropium 18μg q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma

简要总结

主要结局

次要结局

• Forced vital capacity (FVC)(12 weeks)
• AUC0-6hFVC defined in the same way as for FEV1.(Day 1, week 4)
• Trough FVC defined in the same way as for FEV1.(Day 1, week 4)
• Peak FVC defined in the same way as for FEV1(Day 1, week 4)
• Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement).(12 weeks)
• Weekly average number of puffs of rescue medication used(12 weeks)
• Occurrence of adverse events(12 weeks)
• Peak expiratory flow rate (PEFR)(12 weeks)
• Use of rescue medication(12 weeks)
• AUC0-6hFEV1(after first dose on Day 1 and after 4 weeks of treatment)
• Change in trough FEV1 (i.e. trough response) from baseline.(after 4 and 12 weeks of treatment)
• Change in peak FEV1 from baseline (=peak response) after first dose(after 4 and 12 weeks of treatment)
• Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry(12 weeks)
• Change from baseline in Physical examination(12 weeks)