Clinical Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis:An Open-label Randomized Parallel Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement of Sputum volume and properties
研究概览
简要总结
The therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment of bronchiectasis developed in recent years.this study is aim to evaluate the Clinical Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients with Acute Exacerbation of Bronchiectasis.
详细描述
The aim of this study was to evaluate the efficacy and safety of The therapy of bronchoalveolar lavage and local amikacin injection through the observation of a large sample of clinical cases. During the observation, study visits will occur at the end of 30days, 60days, 90days.all the participants will be required to check the various efficacy and safety indicators.
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
- •Age≥18 years and ≤80 years;
- •Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT;
- •Are sensitive to amikacin;
- •Acute exacerbation of bronchiectasis;
- •Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc;
- •Willing to join in and sign the informed consent form.
排除标准
- •Active bleeding without control；
- •Receiving nasal or facial surgery recently；
- •With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc.
- •With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc.
- •Be allergic to amikacin
研究组 & 干预措施
The experimental group
fundamental treatment combining with the therapy of bronchoalveolar lavage and local Amikacin injection.(fundamental treatment including anti-infection,eliminating phlegm,oxygen therapy etc.)
干预措施: Bronchoalveolar Lavage and Local Amikacin Injection (Drug)
结局指标
主要结局
Improvement of Sputum volume and properties
时间窗: 90 days
Phlegm improvement will be measured by the reduction of the sputum volume and change of sputum properties in the first day,in admission,the first day before,in and after doing bronchoscopy ,the day in discharge and in 30 days/60 days/90 days
次要结局
- changes in lung function (including Forced expiratory volume in one second (FEV1) ,forced vital capacity(FVC) and forced vital capacity rate of one second(FEV1/FVC))(90 days)
- Dyspnea score according by Modified Medical Research Center(MMRC)(90 days)
- Cough score according by Leicester Cough Questionnaire(LCQ)(90 days)
- Life quality: assessed by St. George respiratory questionnaire (SGRQ)(90 days)
研究者
Jin-Fu Xu
Director, Head of respiratory medicine
Shanghai Pulmonary Hospital, Shanghai, China