A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,324
- 试验地点
- 2
- 主要终点
- Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
研究概览
简要总结
A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:
- •Smoking history of at least 10 pack-years
- •Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value
- •Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
排除标准
- •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
Glycopyrronium bromide
Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
干预措施: Glycopyrronium bromide (Drug)
Placebo
Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
干预措施: Placebo (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
时间窗: 12 weeks
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
次要结局
- Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment(26 weeks)
- Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment(26 weeks)
- Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment(26 weeks)
- Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)(26 weeks)
- FEV1 at Each Time-point on Day 1 and Week 26(Day 1 and Week 26)
- Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26(Day 1 and Week 26)
- FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26(Day 1, Week 12 and Week 26)
- FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26(Week 12 and Week 26)
- Trough FEV1 and FVC at Day 1 and Week 26(Day 1 and Week 26)
- Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26(Baseline, Day 1, Week 12 and Week 26)
- Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations(26 Weeks and 30 Day follow-up)
- Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period(26 weeks)
- Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period(26 Weeks)
- Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period(26 Weeks)
- Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period(26 Weeks)
- Mean Daily Total Symptom Score Over the 26 Week Treatment Period(26 Weeks)