A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Tolerability of NVA237 (50µg o.d.) Using Tiotropium (18µg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events, Serious Adverse Events or Death
研究概览
简要总结
This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (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
- None
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
- •Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Gold Guideline
- •Current or ex-smokers who have a smoking history of at least 10 pack years.
- •Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7 at Visit 2 (day -7)
排除标准
- •Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
- •Patients requiring long term oxygen therapy
- •Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
- •Patients with concomitant pulmonary disease
- •Patients with a history of asthma
- •Any patient with lung cancer or a history of lung cancer
- •Patients with a history of certain cardiovascular comorbid conditions
- •Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
- •Patients in the active phase of a supervised pulmonary rehabilitation program
- •Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
NVA237
50µg once daily
干预措施: NVA237 (Drug)
Tiotropium
18µg once daily
干预措施: Tiotropium (Drug)
结局指标
主要结局
Number of Participants With Adverse Events, Serious Adverse Events or Death
时间窗: 52 weeks
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
次要结局
- Change in Pre-dose FEV1 From Baseline(Weeks 12, 24, 36 and 52)
- Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation(52 weeks)
- Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period(52 weeks)
- Change in Pre-dose FVC From Baseline(Weeks 12, 24, 36 and 52)
- Number of Patients With Moderate or Severe COPD Exacerbations(52 weeks)
- Change in St. George Respiratory Questionnaire From Baseline(Weeks 12, 24, 36, 52)
- Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period(52 weeks)
- Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period(52 weeks)
- Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period(52 weeks)
- Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period(52 weeks)