NCT00168844已完成3 期
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 983
- 试验地点
- 1
- 主要终点
- TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)
研究概览
简要总结
To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.
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
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tiotropium Respimat 5mcg (Tio R5)
Other
干预措施: Tiotropium Inhalation Solution (Drug)
Tiotropium Respimat 10mcg (Tio R10)
Other
干预措施: Tiotropium Inhalation Solution (Drug)
Placebo
Other
干预措施: Placebo (Other)
结局指标
主要结局
TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)
时间窗: Week 48
Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9 For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined.
COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)
时间窗: 48 weeks
Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year. For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined.
Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)
时间窗: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Trough Forced Expiratory Volume in 1 second (FEV1)
Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)
时间窗: Week 48
Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0
次要结局
- Weekly Mean Evening PEFRs(Weeks 2, 8, 16, 24, 32, 40, 48)
- Weekly Mean Number of Puffs of Rescue Medication Per Day(Weeks 2, 8, 16, 24, 32, 40, 48)
- Mahler TDI Scores(Week 48)
- Saint George's Respiratory Questionnaire (SGRQ) Scores(Week 48)
- COPD Symptoms Scores(Week 48)
- PGE Scores(Week 48)
- PGR Score(Week 48)
- Change From Baseline in Heart Rate(Baseline to Week 40)
- Change From Baseline in PR Interval(Baseline to Week 40 pre-dose)
- Change From Baseline in QRS Interval(Baseline to Week 40 pre-dose)
- Change From Baseline in QT Interval(Baseline to Week 40 pre-dose)
- Change From Baseline in QT Interval (Bazett)(Baseline to Week 40 pre-dose)
- Change From Baseline in QT Interval (Fridericia)(Baseline to Week 40 pre-dose)
- Change From Baseline in Supraventricular Premature Beat (SVPB) Total(Baseline to Week 40)
- Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events(Baseline to Week 40)
- Change From Baseline in SVPB Pairs(Baseline to Week 40)
- Change From Baseline in Ventricular Premature Beat (VPB) Total(Baseline to Week 40)
- Change From Baseline in VPB Run Events(Baseline to Week 40)
- Change From Baseline in VPB Pairs(Baseline to Week 40)
- Change From Baseline in Haematocrit, Packed Cell Volume (PCV)(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Haemoglobin(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Red Blood Cell Count(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Neutrophils (Absolute)(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in White Blood Cell Count(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Platelets(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Neutrophils(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Eosinophils(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Basophils(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Lymphocytes(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Monocytes(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Lymphocytes (Absolute)(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Eosinophils (Absolute)(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Basophils (Absolute)(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Monocytes (Absolute)(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Calcium(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Phosphate(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Alkaline Phosphatase(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Lactic Dehydrogenase (LDH)(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Glucose(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Urea(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Blood Urea Nitrogen(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Creatinine(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Bilirubin, Total(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Uric Acid(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Protein, Total(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Albumin(Baseline to Week 48 or at premature discontinuation if before Week 48)
- Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks(10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication)
- Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks(10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication)
- Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks(10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication)
- Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks(10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication)
- Weekly Mean Morning Pre-dose PEFRs(Weeks 2, 8, 16, 24, 32, 40, 48)
研究者
研究点 (1)
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