A 12-week Multi-center, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of NVA237 in Stable COPD Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Change From Baseline of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing
研究概览
简要总结
The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment.
The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.
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 (Participant, Investigator)
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
NVA237
NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
干预措施: NVA237 (Drug)
Placebo
Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing
时间窗: 12 weeks
The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) at week 12 of treatment. Serial lung function measurements are taken at various time points following dosing at week 12 to calculate the AUC.
次要结局
- Change From Baseline in Trough FEV1 and Pre-dose Trough FEV1 by Visit(Day 2, 86 (trough) Day 15, 29, 57, 85 (pre-dose trough))
- Change From Baseline in FEV1 AUC (0-12H) at Day 1 and FEV1 AUC (0-4h), AUC (4-8h), AUC (8-12h) at Day 1 and Week 12 (Day 85)(Day 1 and Week 12 (Day 85))
- Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire(Week 12)
- Breathlessness Assessed by Transition Dyspnea Index (TDI) Focal Score at Week 12(Week 12)
- Percentage of Nights With "no Nighttime Awakenings"(from Baseline up to 12 weeks)
- Percentage of Participants With a Clinically Important Improvement of >=4units in the SGRQ Total Score at Week 12(Week 12)
- Percentage of "Days Able to Perform Usual Daily Activities"(from Baseline up to 12 weeks)
- Percentage of Days With "no Daytime Symptoms"(from Baseline up to 12 weeks)
- Change From Baseline of Forced Expiratory Volume in One Second (FEV1) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)(Baseline, Day 1 and Week 12 (Day 85))
- Change From Baseline of Daily Symptom Scores(12 weeks)
- Change From Baseline of Morning and Nighttime Symptom Scores at Week 12(12 weeks)
- Percentage of Days Without Rescue Medication Use(12 weeks)
- The Average Number of Puffs of Rescue Medication Per Day(baseline and 12 weeks)
- Change From Baseline of Forced Vital Capacity (FVC) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)(Baseline, Day 1 and Week 12 (Day 85))