Randomised, Open-label, Parallel-group Study of Therapeutic Effect of Different Treatment Course With Inhaled Corticosteroids in Eosinophilic Bronchitis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- The primary outcome was the relapse rate of eosinophilic bronchitis in one year.
研究概览
简要总结
This study aims to observe the therapeutic effect of different treatment course with inhaled corticosteroids in eosinophilic bronchitis patients.
The investigators hypothesize:
- Cough score will be improved after treatment with longer treatment course with inhaled corticosteroids in EB patients.
- The sputum eosinophil percentage will be decreased and recovered to normal level (Eos%<2.5%) with longer treatment course with inhaled corticosteroids in EB patients.
- The rate of recurrence after treatment will be decrease with longer treatment course with inhaled corticosteroids in EB patients
详细描述
Study groups:
Patients diagnosed with EB will be randomised into three groups as follows:
Group 1(4-week treatment group):The patients with eosinophilic bronchitis received Pulmicourt Turbuhaler (Budesonide 100µg) 2puff Q12h for 4 weeks.
Group 2(8-week treatment group):The patients with eosinophilic bronchitis received Pulmicourt Turbuhaler (Budesonide 100µg) 2puff Q12h for 8 weeks.
Group 3(16-week treatment group):The patients with eosinophilic bronchitis received Pulmicourt Turbuhaler (Budesonide 100µg) 2puff Q12h for 16 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have a history of cough as sole or main symptom lasting more than 3 weeks.
- •Patients whose chest x-ray outcome was normal or without any active focus.
- •Patients who were diagnosed with the result of sputum eosinophil percentage (Eos%) over 2.5%, and the negative result in bronchial provocation test by methacholine inhalation challenge.
- •Patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).
排除标准
- •Patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history >10 pack-years or equivalence.
- •Patients with concomitance of GERC (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, ACEI induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
- •Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
- •Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
- •Subjects who have received any therapy in the previous 4 weeks, e.g.corticosteroids ,antihistamines, leukotriene receptor antagonist in previous 4 weeks
- •Subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
- •Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.
研究组 & 干预措施
Inhaled budesonide for 4 weeks
inhaled Budesonide 100µg , 2puff Q12h for 4 weeks
干预措施: Inhaled budesonide (Drug)
Inhaled budesonide for 8 weeks
inhaled Budesonide 100µg , 2puff Q12h for 8 weeks
干预措施: Inhaled budesonide (Drug)
Inhaled budesonide for 16 weeks
inhaled Budesonide 100µg , 2puff Q12h for 16 weeks
干预措施: Inhaled budesonide (Drug)
结局指标
主要结局
The primary outcome was the relapse rate of eosinophilic bronchitis in one year.
时间窗: 1 year
次要结局
- change in percentage of eosinophil in induced sputum from baseline to post-treatment(week 0,week 4,week 8,week 16)
- change in Cough visual analogue scale (VAS) and Cough Symptom Score (CSS) from baseline to post-treatment(week 0,week 4,week 8,week 16)
研究者
Kefang Lai
professor
The First Affiliated Hospital of Guangzhou Medical University