The Comparisons of the Efficacy and Safety of Inhaled LAMA or LAMA+LABA or ICS+LABA for Patients in COPD C Group With Bronchiectasis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Acute exacerbation
研究概览
简要总结
The purpose of this study is to determine which treatment is more effective and safer for the patients in COPD C group with bronchiectasis.The research results will help guide physicians to select appropriate individualized treatment and hopefully provide some evidence-based medicine proofs for revising guide.
详细描述
The diagnosis and treatment of COPD and bronchiectasis together seems to be more complicated than the diagnosis and treatment of either condition alone. According to the GOLD，there are three treatments for patients with COPD in group C: ICS combined with LABA or LAMA alone or LABA combined with LAMA. However, it has not yet been demonstrated about which method is more effective for the patients with COPD in group C and bronchiectasis.
This study is designed as a prospective, randomized, case-control trial. Patients are divided into three groups, one group inhaled with ICS and LABA (Symbicort), the second group inhaled with LAMA (Tiotropium Bromide) and the third group inhaled with LAMA(Tiotropium Bromide) and (Symbicort).The course of treatment is 12 months.
The investigators will also assess other relevant outcomes, including the quality of life (QOL) score, pulmonary function test and the incidence of adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are suitable for inclusion in the study when they are 18 years or older diagnosed with COPD C group and bronchiectasis.
排除标准
- •active tuberculosis
- •severe respiratory disease (such as Lung cancer, ARDS, pulmonary encephalopathy, respiratory failure)
- •uncontrollable diabetes
- •hypersensitivity to any components of ICS/LABA or LAMA.
研究组 & 干预措施
ICS/LABA Group
Symbicort，Inhalation，Individualized medication，12 months.
干预措施: Symbicort (Drug)
LAMA Group
Tiotropium Bromide，Inhalation,Individualized medication，12 months.
干预措施: Spiriva (Drug)
LAMA+LABA Group
Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.
干预措施: Symbicort (Drug)
LAMA+LABA Group
Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.
干预措施: Spiriva (Drug)
结局指标
主要结局
Acute exacerbation
时间窗: 12 months
The times of acute exacerbation during the trial.
次要结局
- SGRQ(12 months)
- LCQ(12 months)
- CAT(12 months)
- FEV1/FVC(12 months)
- mMRC(12 months)
- Number of patients with adverse events(12 months)
- FEV1(12 months)
- FVC(12 months)
研究者
Jin-Fu Xu
Department of Respiratory Medicine
Shanghai Pulmonary Hospital, Shanghai, China