NCT01119950已完成2 期
A Randomized, Double-blind, Placebo-controlled, 2-period, Cross-over Study to Assess the Efficacy and Safety of Differing Doses of NVA237 Administered Either Once Daily or Twice Daily, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 2
- 主要终点
- Maximal Response of Incremental Once Daily and Twice Daily Doses of NVA237 That Each Dose Achieves in Relation to the Maximal Effect of NVA237 on Trough Forced Expiratory Volume in One Second at Day 28
研究概览
简要总结
This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Male and female patients age 40 years or more
- •Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified by the Global Initiative for COPD (GOLD) Guidelines, 2008
- •Smoking history of at least 10 pack-years
- •Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) <80% and ≥30% of the predicted normal value
- •Post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.7
- •Symptomatic patients, according to daily electronic diary data between visit 2 (Day -8) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3
排除标准
- •Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to the first visit
- •Patients who have had a respiratory tract infection within 4 weeks prior to the first visit
- •Patients with concomitant pulmonary disease
- •Patients with diabetes Type I or uncontrolled diabetes Type II
- •Any patient with lung cancer or a history of lung cancer
- •Patients with a history of certain cardiovascular co-morbid conditions
- •Patients with a history of asthma or a blood eosinophil count >600/mm3 or onset of symptoms prior to 40 years
- •Patients with eczema, known high IgE levels or a known positive skin prick test
- •Patients participating in the active phase of a pulmonary rehabilitation programme
- •Patients contraindicated for the treatment with anticholinergics, long and short-acting beta-2 agonists or sympathomimetic amines
- •Patients with a history of alpha-1 anti-trypsin deficiency
- •Patients on long term oxygen therapy (>15hr per day)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
NVA237 12.5 µg q.d.
Experimental
NVA237 12.5 µg once daily
干预措施: NVA237 12.5 µg once daily (Drug)
NVA237 25.0 µg q.d.
Experimental
NVA237 25.0 µg once daily
干预措施: NVA237 25.0 µg once daily (Drug)
NVA237 12.5 µg b.i.d.
Experimental
NVA237 12.5 µg twice daily
干预措施: NVA237 12.5 µg twice daily (Drug)
NVA237 50.0 µg q.d.
Experimental
NVA237 50.0 µg once daily
干预措施: NVA237 50.0 µg once daily (Drug)
NVA237 25.0 µg b.i.d.
Experimental
NVA237 25.0 µg twice daily
干预措施: NVA237 25.0 µg twice daily (Drug)
NVA237 100.0 µg q.d.
Experimental
NVA237 100.0 µg once daily
干预措施: NVA237 100.0 µg once daily (Drug)
NVA237 50.0 µg b.i.d.
Experimental
NVA237 50.0 µg twice daily
干预措施: NVA237 50.0 µg twice daily (Drug)
Placebo
Placebo Comparator
Placebo to NVA237 once daily
干预措施: Placebo to NVA237 once daily (Drug)
结局指标
主要结局
Maximal Response of Incremental Once Daily and Twice Daily Doses of NVA237 That Each Dose Achieves in Relation to the Maximal Effect of NVA237 on Trough Forced Expiratory Volume in One Second at Day 28
时间窗: Day 28
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. The maximal response of incremental once daily and twice daily doses of NVA237 that each dose achieves in relation to the maximal effect of NVA237 on Trough FEV1 was measured at Day 28. FEV1 was measured in response to all doses administered (see Outcome Measure #19). All trough FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All trough FEV1 data are reported as a percentage of the theoretical maximal response. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values.
次要结局
- Forced Expiratory Volume in One Second AUC 0-24 Hours for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237, After 28 Days of Treatment(-25 min,-15 min (predose); 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28)
- Trough Forced Expiratory Volume in One Second for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237(day 28)
- Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours at Day 28 of Treatment(5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28)
- Percentage of the Maximal Response of NVA237 Doses on Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14(Days 1, 7 and 14)
- Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours) on Day 28(5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28)
- Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-12 Hours at Day 1 and 14 of Treatment(5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14)
- Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours at Day 28 of Treatment(12 hours on day 28)
- Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second at Day 28 of Treatment(day 28)
- Percentage of the Maximal Response of NVA237 Doses on Forced Vital Capacity at Day 28 of Treatment(day 28)
- Percentage of the Maximal Effect of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours on Days 1 and 14 of Treatment(5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14)
- Percentage of the Maximal Response of NVA237 Doses on Trough Forced Vital Capacity on Days 1, 7 and 14(Days 1, 7 and 14)
- Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment(Days 1, 7, and 14)
- Mean Daily Use of Rescue Medication by Treatment at Different Time Points(Baseline, Weeks 1, 2, 3 and 4)
- Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-4 Hours on Days 1, 7 and 14 of Treatment(5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14)
- Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 0-8 Hours Days 1, 7, and 14(at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14)
- Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 12-24 Hours Over Days 1, and 14 of Treatment(11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14)
- Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment(Days 1 and 14)
研究者
研究点 (2)
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