NCT00291408撤回4 期
A Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Effect of Symbicort® and Pulmicort® on HAT and HDAC Expression and Activity in Induced Sputum Cells Obtained From COPD Patients.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- HDAC and HAT activity ratio
研究概览
简要总结
The purpose of the study is to compare histone acetyltransferase (HAT) and histone deacetylase (HDAC) expressions and activities in induced sputum macrophages obtained from patients with moderate to severe COPD and age-matched normal non-smokers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria-Healthy non-smokers
- •Non-smoking volunteer
- •aged 40 -75 years (age matched to COPD patients)
- •Normal spirometry (normal FEV1/FVC ratio >70% and FEV1>80% predicted)
- •Subjects are able to give informed consent
- •Inclusion Criteria-COPD patients (stage II-III according to the GOLD guidelines)
- •Current and/or ex-smokers with no less than 10 pack-year smoking history
- •aged 40 -75 years
- •FEV1 greater than or equal to 30% and less than 80% of predicted (the upper value is a prostbronchodilator value)
- •FEV1/FVC < 70%
- •Patients with stable COPD
- •Inhaled Corticosteroid (ICS) treatment, if exists, must be stopped for 2 weeks prior the study treatment
- •Long-acting beta2-agonists and theophylline need to be stopped at least 3 days before run-in , but anti-cholinergics will be allowed throughout the study
- •The subjects are able to give informed consent
排除标准
- •Exclusion Criteria-Healthy non-smokers
- •Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
- •Upper respiratory infection within the last 4 weeks
- •Subjects who have received research medication within the previous one month
- •Subjects unable to give informed consent
- •Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- •Exclusion Criteria-COPD patients
- •Evidence of asthma
- •Bronchodilator reversibility > 12%
- •Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
- •Patients who have had oral steroids within 8 weeks prior to the screening visit.
- •Patients who are already on ICS and in which it is considered unsafe (as judged by the Investigator) to stop this treatment for the study period.
- •Patients who have had an exacerbation which required treatment with oral steroids during the last 2 months prior to the screening visit.
- •Upper respiratory infection within the last 4 weeks
- •Subjects who have received research medication within the previous one month
- •Subjects unable to give informed consent
- •Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •Patients with significant co-morbidities as judged by the investigator
- •Any other respiratory disease, which is considered by the investigator to be clinically significant
结局指标
主要结局
HDAC and HAT activity ratio
次要结局
- Several inflammation and anti-inflammation markers and lung function will be evaluted as shown below.
研究者
研究点 (2)
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