NCT01443845已完成4 期
Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,354
- 试验地点
- 338
- 主要终点
- Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.
研究概览
简要总结
To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe 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
- Triple (Participant, 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 or female patients at least 40 years of age
- •History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
- •Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) < 70% at Screening (Visit 1)
- •FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
- •At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
- •Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
- •Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years
排除标准
- •Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
- •Known alpha-1-antitrypsin deficiency
- •Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
- •Body mass index (BMI) ≥ 45 kg/m2
- •Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer
研究组 & 干预措施
1
Experimental
Roflumilast
干预措施: Roflumilast (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.
时间窗: Baseline to Week 52
Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.
次要结局
- Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)(Week 0 (Visit 2) to Week 52)
- Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics(Week 0 (Visit 2) to Week 52)
- Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)(Week 0 (Visit 2) to Week 52)
研究者
研究点 (338)
Loading locations...
相似试验
已完成
2 期
Roflumilast Plus Montelukast in Adults With Severe AsthmaAsthmaNCT01765192AstraZeneca64
已完成
2 期
Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical StudyDiabetes Mellitus Type 2NCT01140542AstraZeneca487
终止
2 期
Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory ImagingPulmonary Disease, Chronic ObstructiveNCT02451540FLUIDDA nv13
进行中（未招募）
不适用
500 mcg roflumilast once daily in combination with 50 mcg salmeterol twice daily versus 50 mcg salmeterol twice daily alone over 52 weeks in patients with COPD. A double blind, parallel group, phase IIIb clinical study.Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 6.1Level: PTClassification code 10009026EUCTR2004-004442-40-ITALTANA PHARMA
进行中（未招募）
1 期
500µg roflumilast once daily in combination with 50µg salmeterol twice daily versus 50µg salmeterol twice daily alone over 52 weeks in patients with COPD. - ROCKETEUCTR2004-004442-40-ESALTANA Pharma AG876