Effeciency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of Asthma-chronic Obstructive Pulmonary Overlap: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- the frequency of ACO exacerbation
研究概览
简要总结
This study evaluates the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium) in the treatment of acute exacerbation of asthma-chronic obstructive pulmonary overlap. Half of participants will receive budesonide,formoterol and tiotropium in combination, while the other half will receive budesonide and formoterol only.
详细描述
ACO(asthma-chronic obstructive pulmonary overlap) is a relatively new proposed clinical form of chronic airway disease. Guideline or preferring therapy for ACO is still evolving. Current clinical solution is when ACO presents like asthma, initial treatment will accord to the guideline for asthma , while it presents like COPD, COPD recommendation treatment (not alone ICS,but ICS in addition of LABA with or without LAMA) will be chosen, which are subjective. Although present guidelines has recommended that ACO should be treated with at last two inhalant, but limited date have proven it.
A random controlled trial will be conducted to evaluate the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium bromide) in the treatment of acute exacerbation of ACO,compared with the control group receiving tiotropium bromide with formoterol only.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject has ACO
排除标准
- •acute exacerbation of ACO;
- •acute infection;
- •postbrochodilator FEV1/FVC> 0.7;
- •pulmonary complications: bronchiectasis, active tuberculosis, pulmonary fungal disease or lung cancer
- •history of other malignant tumor
- •with rheumatic diseases;
- •with some serious heart, cerebrovascular, liver, kidney or hematopoietic system diseases
- •with tachyarrhythmias；
- •mental patients;
- •with moderate to severe renal insufficiency (creatinine clearance ≤ 50ml / h)
- •allergic to the budesonide, formoterol or tiotropium bromide;
- •history of acute gastrointestinal bleeding within 3 months;
- •with severe angle closure glaucoma patients;
- •pregnancy,lactation;
- •have participated in other clinical trials in 3 months；
- •hospital staff and their relatives
研究组 & 干预措施
triple combinations
Budesonide/Fermotil inhalant 160ug/4.5ug bid; Tiotropium bromide inhalants 18ug qd
干预措施: triple combinations (Drug)
double combinations
Fermotil inhalants 4.5ug bid; Tiotropium bromide inhalants 18ug qd
干预措施: double combinations (Drug)
结局指标
主要结局
the frequency of ACO exacerbation
时间窗: 12 months
the frequency of ACO exacerbation
次要结局
- postbronchodilator FEV1(12 months)
- mMRC score(12 months)
- times of hospital readmission caused by exacerbation(12 months)
- CAT score(12 months)
- ACT score(12 months)
- other lung function parameters(12 months)
- CCQ score(12 months)
研究者
Shengqing Li
Chief physician, professor
Huashan Hospital