Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), before and after treatment.
研究概览
简要总结
This study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
详细描述
Diagnosis and criteria for inclusion and exclusion:
Inclusion:
- Male or female outpatients aged 40 years≧
- Current or ex-smoker, with smoking history 10 pack≧- years
- COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator)
Exclusion:
- Diagnosis or suspicion of sleep apnea.
- Concurrent rhinitis, eczema, and asthma.
- Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
- A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
- Major disease abnormalities are uncontrolled on therapy.
- Alcohol or medication abuse.
- Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
- Unable or unwilling to comply with all protocol
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
- None
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
- •Male or female outpatients aged 40 years≧
- •Current or ex-smoker, with smoking history 10 pack≧- years
- •COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator)
排除标准
- •Diagnosis or suspicion of sleep apnea.
- •Concurrent rhinitis, eczema, and asthma.
- •Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
- •A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
- •Major disease abnormalities are uncontrolled on therapy.
- •Alcohol or medication abuse.
- •Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
- •Unable or unwilling to comply with all protocol
研究组 & 干预措施
Fluticasone/salmeterol high dose
COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)
干预措施: Fluticasone/Salmeterol high dose (Drug)
Fluticasone/Salmeterol medium dose
COPD patients treating with medium dose of ICS (Fluticasone 500ug/day) combined with Salmeterol (25ug/day)
干预措施: Fluticasone/Salmeterol high dose (Drug)
结局指标
主要结局
The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), before and after treatment.
时间窗: Lung function change in one year
We will compare the lung function changed in COPD patients treating with different doses of Fluticasone (500 and 1000ug)
次要结局
- Annual rate of acute exacerbations(percentage of acute exacerbation in one year)
研究者
Shih-Lung Cheng
Division of Pulmonary Medicine, Department of Internal Medicine
Far Eastern Memorial Hospital