NCT00152984已完成4 期
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
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 472
- 试验地点
- 68
- 主要终点
- AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose)
研究概览
简要总结
The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD and diagnosis of asthma before the age of 30
- •Current or ex-smokers with a cigarette smoking history of at least 10 pack-years
- •Treatment with inhaled steroids at least 1 year before study entry
- •FEV1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years
- •FEV1 increase of more than 200 mL 30 min. after 400 mcg salbutamol or documented increase of 200 mL after reversibility test within the last 5 years
- •Post bronchodilator FEV1 less than 80% predicted normal (ECCS) at visit 1
- •Post bronchodilator FEV1 less than 70% of FVC at visit 1
排除标准
- •Respiratory infection or exacerbation 6 weeks prior to Visit 1 or during run-in period.
- •Significant diseases other than COPD or asthma
- •Myocardial infarction within the last 6 months
- •Unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year
- •Hospitalisation for heart failure (NYHA Class III or IV) within the last year
- •History of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
- •Known active tuberculosis
- •History of thoracotomy with pulmonary resection
- •History of cancer within the last 5 years (excluding treated basal cell carcinoma)
- •Patients requiring oxygen therapy for more than 1 hour per day
- •Patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before Visit 1
- •Known hypersensitivity to anticholinergic drugs or lactose
结局指标
主要结局
AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose)
时间窗: after 12 weeks of treatment
次要结局
- Peak expiratory flow rate (PEFR)(12 weeks)
- 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)
- 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)
- 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)
研究者
研究点 (68)
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