Efficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 主要终点
- Actue exacerbation
研究概览
简要总结
Airflow limitation is common exist in idiopathic bronchiectasis patients. However, there are few evidence on the treatment of bronchodilator in bronchiectasis with airflow limitation. The efficacy and safety of dual bronchodilator in idiopathic bronchiectasis with airflow limitation are still unclear. Thus, the investigators conduct a multicenter, open-label randomized controlled trial to investigate the efficacy and safety of dual bronchodilator in idiopathic bronchiectasis with airflow limitation.
详细描述
Airflow limitation is common exist in idiopathic bronchiectasis patients. Our previous studies showed that FEV1<50% is one of the major risk factors for poor prognosis and high incidence of acute exacerbation in patients with bronchiectasis. However, there are few evidence on the treatment of bronchodilator in bronchiectasis with airflow limitation, and there is no recommendation in bronchiectasis guidelines. Moreover, because of the high risk of infection and bacterial colonization in bronchiectasis, there is still unclear whether inhaled corticosteroids or bronchodilators affect the parameters of bronchiectasis. Thus, there is urgent need to optimize the treatment of bronchiectasis with airflow limitation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic bronchiectasis with FEV1/FVC < 70%
排除标准
- •With Asthma
- •α-1 antitrypsin deficiency
- •Turculosis
- •Lung cancer
- •Sarcoidosis
- •Idiopathic pulmonary fibrosis
- •Primary pulmonary hypertension
- •Uncontrolled sleep apnea
- •Bronchiectasis accepted long-term low dose macrolides
- •Pulmonary surgery within 6 months
- •Lower respiratory tract infections require antibiotic treatment in 6 weeks
- •Upper respiratory tract infection did not recover for at least 7 days
- •With Glaucoma or severe prostate hyperplasia that can not use Indacaterol
- •Patients allergic to experimental drugs
- •Women pregnant, breast-feeding or who planned a pregnancy during the study
研究组 & 干预措施
Experimental group
Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.
干预措施: LABA/LAMA or Placebo inhalation (Drug)
Control group
Placebo treatment for the airway limitation.
干预措施: LABA/LAMA or Placebo inhalation (Drug)
结局指标
主要结局
Actue exacerbation
时间窗: One year
Times of acute exacerbation
次要结局
- Questionnaire of life-Bronchiectasis(Six months)
- Leicester Cough Questionnaire(Six months)
- FEV1%(Six months)
- FEV1, FVC(Six months)
- Incidence of atrial fibrillation(Six months)
- modified Medical Research Council score(Six months)
- Incidence of coronary artery disease(Six months)
研究者
Jin-Fu Xu
Chief of Department of Pulmonary and Critical Care Medicine
Shanghai Pulmonary Hospital, Shanghai, China