A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol DISKUS® Inhaler Combination Product 250/50mcg Twice Daily With Salmeterol DISKUS® Inhaler 50mcg Twice Daily on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 740
- 试验地点
- 1
- 主要终点
- Rate of moderate/severe exacerbations over a 52 week treatment period.
研究概览
简要总结
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the FDA for use in patients with COPD.
详细描述
A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS® inhaler Combination Product 250/50mcg twice daily (BID) with Salmeterol DISKUS® inhaler 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with 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
- 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
- •Diagnosis of COPD (chronic obstructive pulmonary disease).
- •Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
- •History of a least 1 COPD exacerbation in the 12 months prior to screening.
- •Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.
排除标准
- •Current diagnosis of asthma.
- •Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
- •Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
- •Lung resection surgery within 1 year of screening.
- •Abnormal and clinically significant ECG findings at screening.
- •Other inclusion and exclusion criteria will be evaluated at the first study visit.
研究组 & 干预措施
Arm 1
干预措施: Salmeterol (Drug)
Arm 1
干预措施: Fluticasone Propionate/Salmeterol Combination Product (Drug)
结局指标
主要结局
Rate of moderate/severe exacerbations over a 52 week treatment period.
次要结局
- The time until the first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year.