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
- 432
- 试验地点
- 1
- 主要终点
- Change From Baseline in Standardized Area Under the Curve for Forced Expiratory Volume in One Second 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 in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing
时间窗: Week 12
The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is measured at week 12 of treatment. Serial lung function measurements are taken at the following time points following dosing at week 12 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. The primary endpoint was the change from baseline in FEV1 AUC0-12h following the morning dose at Week 12 (defined as the mean FEV1 change from baseline (CFB) over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur
次要结局
- Change From Baseline in Mean Number of Puffs of Rescue Medication Per Day(Baseline and week 12)
- Change From Baseline in Daily Symptom Scores(day 1 to week 12)
- Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire(Week 12)
- Change From Baseline in the Percentage of Days Without Rescue Medication Use(Baseline and week 12)
- Change From Baseline in Standardized Area Under the Curve (AUC(0-12h)) for Forced Expiratory Volume in One Second Post Dosing(Day 1)
- Change From Baseline in Standardized Area Under The Curve for Forced Expiratory Volume in One Second for Different Time Spans Post Dosing(Day 1 and Week 12)
- Mean Trough Forced Expiratory Volume in One Second(Day 1 and week 12)
- Breathlessness Assessed by Transition Dyspnea Index(Week 12)
- Change From Baseline in Forced Expiratory Volume in One Second at All Individual Timepoints(Day 1 and week 12)
- Change From Baseline in the Percentage of Nights With "no Nighttime Awakenings"(Day 1 and week 12)
- Change From Baseline in the Percentage of Days With "no Daytime Symptoms"(Day 1 to week 12)
- Change From Baseline in Mean Trough Forced Vital Capacity(Day 1 and week 12)
- Change From Baseline in Morning and Nighttime Symptom Scores(Day 1 to week 12)
- Change From Baseline in Percentage of "Days Able to Perform Usual Daily Activities"(Day 1 to week 12)
- Change From Baseline in Forced Vital Capacity at All Individual Timepoints(Day 1 and week 12)