Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,991
- 试验地点
- 334
- 主要终点
- Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
研究概览
简要总结
The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- •Male or female
- •At least 40 years old
- •Smoker or ex-smoker
- •Smoking history > 10 pack-years
- •Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted
排除标准
- •Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
- •History of asthma or allergic conditions.
- •Malignancy requiring treatment within past 5 years
- •Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
- •Known active tuberculosis
- •Known hypersensitivity to anticholinergic drugs.
研究组 & 干预措施
Tiotropium
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
干预措施: Tiotropium (Drug)
Placebo
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
干预措施: Respimat (Device)
结局指标
主要结局
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
时间窗: Baseline and Day 337
Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
时间窗: During actual study treatment period (planned Day 1 to Day 337)
Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.
次要结局
- Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29(Baseline and Day 29)
- Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169(Baseline and Day 169)
- Number of COPD Exacerbations Per Patient - Exposure Adjusted(During actual study treatment period (planned Day 1 to Day 337))
- Number of COPD Exacerbations Per Patient - naïve Estimate(During actual study treatment period (planned Day 1 to Day 337))
- Number of Patients With at Least One COPD Exacerbation(During actual study treatment period (planned Day 1 to Day 337))
- Time to First Hospitalisation for COPD Exacerbation(During actual study treatment period (planned Day 1 to Day 337))
- Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted(During actual study treatment period (planned Day 1 to Day 337))
- Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate(During actual study treatment period (planned Day 1 to Day 337))
- Number of Patients With at Least One Hospitalisation for a COPD Exacerbation(During actual study treatment period (planned Day 1 to Day 337))
- Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337(Baseline and Day 337)
- Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169(Baseline and Day 169)
- Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337(Baseline and Day 337)
- Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169(Baseline and Day 169)
- Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29(Baseline and Day 29)
- Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169(Baseline and Day 169)
- Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337(Baseline and Day 337)
- Marked Changes From Baseline in Vital Signs at End of Treatment(Baseline and end of treatment)
- Clinically Relevant Findings in Physical Examination and ECG(End of treatment)