Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 55
- 主要终点
- morning peak expiratory flow rate (PEFR)
研究概览
简要总结
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.
详细描述
This was a multicentre, randomised, double blind, parallel group, placebo-controlled, one year study. It was designed to determine the effect of inhaled tiotropium treatment on airflow obstruction (PEFR), incidence and severity of exacerbations in patients with COPD.
Following an initial 3-week screening period qualifying patients were randomized to either tiotropium or placebo at Visit 2. Patients returned to the clinic at weeks 6 (Visit 3), 12 (Visit 4), 24 (Visit 5), 36 (Visit 6), 48 (Visit 7) and at Week 50 for the conclusion of the trial (Visit 8). The patients received treatment daily for 48 weeks (336 days).
PEFR, as well as use of rescue medication and respiratory condition, were self-assessed by patients and recorded every morning on a graphical diary card every morning. The graphical presentation of these data was supposed to help investigators to detect exacerbations occurring between two consecutive visits.
Details on hospitalizations due to COPD exacerbations were recorded in a special hospitalization booklet.
Study Hypothesis:
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
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD according to the European Respiratory Society (ERS) (R95-3225) and matching the following criteria:
- •Stable moderate to severe airway obstruction
- •Baseline 30 % < FEV1 < 65 % of European Community of Coal and Steel (ECCS) predicted values (R94-1408).
- •Baseline FEV1/SVC< 70 %.
- •Smoking history > 10 pack-years (p.y.). A p.y. was defined as the equivalent of smoking
- •One pack of cigarettes per day for one year.
- •History of exacerbation in the past year.
排除标准
- 未提供
结局指标
主要结局
morning peak expiratory flow rate (PEFR)
时间窗: 50 weeks
次要结局
- spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC)(50 weeks)
- Adverse events, physical examination(50 weeks)
- incidence, severity and duration of exacerbations(50 weeks)
- number of patients with one or more exacerbation(50 weeks)
- rate of PEFR drops(50 weeks)
- number of lost working days(50 weeks)
- bacterial and viral characterisation of severe exacerbations(50 weeks)
- plethysmography (RV, TLC) (optional)(50 weeks)
- number of days of hospitalisation(50 weeks)
- use of rescue medications, type and duration(50 weeks)