Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Bronchiectasis

Intervention / Treatment
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* Drug: Bronchoalveolar Lavage and Local Amikacin Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The experimental group<br>fundamental treatment combining with the therapy of bronchoalveolar lavage and local Amikacin injection.(fundamental treatment including anti-infection,eliminating phlegm,oxygen therapy etc.) | Drug: Bronchoalveolar Lavage and Local Amikacin Injection<br>* injecting 0.4g of AK in 100 ml to 250 ml, not exceeding 300 ml. And generally, repeat it for 3 to 5 times.<br>* Other names: Amikin;AMK;|
| No Intervention: The controlled group<br>fundamental treatment(including anti-infection,eliminating phlegm,oxygen therapy etc.) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Sputum volume and properties | 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 | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)) | Lung function will be measured as improved/stabilized/exacerbated from baseline to 30 days/60 days/90 days | 90 days | 
| Dyspnea score according by Modified Medical Research Center(MMRC) | to measure rating dyspnea according by Medi Medical Research Center(MMRC) from baseline to 30 days/60 days/90 days | 90 days | 
| Cough score according by Leicester Cough Questionnaire(LCQ) | to measure rating cough according by Leicester Cough Questionnaire(LCQ) from baseline to 30 days/60 days/90 days | 90 days | 
| Life quality: assessed by St. George respiratory questionnaire (SGRQ) | Life quality will be assessed as improved if SGRQ single or total score increased >4% when completing the trial; stabilized if SGRQ single or total score changes within the range of 4% when completing the trial; exacerbated if SGRQ single or total score decreased >4% when completing the trial from baseline to 30 days/60 days/90 days | 90 days |