1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 220
- 试验地点
- 72
- 主要终点
- Trough forced expiratory volume in one second (FEV1) response
研究概览
简要总结
The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index/Transition Dyspnoea Index (BDI/TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tiotropium/Salmeterol quaque die (QD, once daily)
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
干预措施: Tiotropium/Salmeterol QD (Drug)
Tiotropium quaque die (QD, once daily)
Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
干预措施: Tiotropium (Spiriva®) (Drug)
Salmeterol bis in die (BID, twice daily)
Salmeterol Inhalation Powder, hard PE capsule
干预措施: Salmeterol (Drug)
Tiotropium/Salmeterol quaque die (QD, once daily)+ Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
干预措施: Tiotropium/Salmeterol QD+ Salmeterol (Drug)
Placebo
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Trough forced expiratory volume in one second (FEV1) response
时间窗: 12 Weeks, 24 Weeks and 48 Weeks
FEV1 area under the curve (AUC) 0-8h response
时间窗: 12 Weeks, 24 Weeks and 48 Weeks
Mahler Transition Dyspnoea Index (TDI) focal score
时间窗: 12 Weeks, 24 Weeks and 48 Weeks
St George Respiratory Questionnaire (SGRQ) total score
时间窗: 12 Weeks, 24 Weeks and 48 Weeks
Time to first moderate to severe COPD exacerbation
时间窗: 12 Weeks, 24 Weeks and 48 Weeks
次要结局
- All adverse events(48 weeks)
- Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort)(4, 12, 24, 36 and 48 weeks)
- SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ(4, 12, 36 and 48 weeks)
- Routine blood chemistry, haematology and urinalysis(Baseline and 48 weeks)
- FEV1 AUC 0-8h response(4, 36 and 48 weeks)
- Trough FEV1 response(4, 36 and 48 weeks)
- Peak FEV1 response(12, 24, 36 and 48 weeks)
- Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time)(24 hours)
- Forced vital capacity (FVC) AUC0-8h and trough FVC response(48 weeks)
- Individual FEV1, FVC and peak expiratory flow (PEF) measurements(48 weeks)
- Weekly mean morning pre-dose and evening pre-dose PEFs and FEV1 (recorded by Asthma Monitor® 2 (AM2+)); PEFs determined by spirometry ](48 weeks)
- Weekly mean number of COPD related night time awakenings(1 week)
- Vital status of randomised patients(48 weeks)
- Mahler TDI focal score(4, 36 and 48 weeks)
- Vital signs: pulse rate and blood pressure(Baseline and 4 weeks)
- Number of days in hospital (including ambulance transportation(48 weeks)
- Number of unscheduled health care provider visits(48 weeks)
- Number of visits in emergency room (including ambulance transportation)(48 weeks)
- Number of days in intensive care unit(48 weeks)
- Concomitant medications (for instance antibiotics and systemic steroids).(48 weeks)