NCT00361959已完成4 期
Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104-week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE*) 50/500mcg Delivered Twice Daily Via the DISKUS*/ACCUHALER* Inhaler With Tiotropium Bromide 18 mcg Delivered Once Daily Via the HandiHaler Inhalation Device on the Rate of Health Care Utilisation Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,270
- 试验地点
- 166
- 主要终点
- Rate of healthcare utilisation based exacerbations of COPD
研究概览
简要总结
This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.
详细描述
A Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104 Week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE) 50/500mcg with Tiotropium Bromide 18 mcg on the Rate of Exacerbations in Subjects with 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
- Double
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established clinical history of moderate to severe COPD.
- •Post bronchodilator FEV1 of < 50% of predicted normal.
- •FEV1 / FVC ratio <70%.
- •Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit
- •Free from exacerbation in the 6 weeks prior to screening.
- •Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations.
排除标准
- •Current asthma, eczema, atopic dermatitis and/or allergic rhinitis.
- •Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis).
- •Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study.
- •Has undergone lung transplantation and/or lung volume reduction.
- •Female who is a nursing mother.
- •Requires regular (daily) long-term oxygen therapy (LTOT).
- •Is receiving beta-blockers (except eye drops).
- •Has a serious, uncontrolled disease likely to interfere with the study.
- •Has received any other investigational drugs within the 4 weeks prior to Visit
- •Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
- •Has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids, anticholinergic agents or any components of the formulations (e.g. lactose or milk protein).
结局指标
主要结局
Rate of healthcare utilisation based exacerbations of COPD
次要结局
- Rates for exacerbations based on symptoms, treatment with oral corticosteroids and for antibioticsTime to next exacerbation, duration and difference between healthcare utilisation and symptom based exacerbation
研究者
研究点 (166)
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