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

Shanghai Pulmonary Hospital, Shanghai, China100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Bronchiectasis

Interventions

Bronchoalveolar Lavage and Local Amikacin InjectionDRUG

injecting 0.4g of AK in 100 ml to 250 ml, not exceeding 300 ml. And generally, repeat it for 3 to 5 times.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age≥18 years and ≤80 years; 2. Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT; 3. Are sensitive to amikacin; 4. Acute exacerbation of bronchiectasis; 5. Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc; 6. Willing to join in and sign the informed consent form. Exclusion Criteria: 1. Active bleeding without control； 2. Receiving nasal or facial surgery recently； 3. With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc. 4. With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc. 5. Be allergic to amikacin

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 90 days

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 90 days

Central Contacts

Jin-Fu Xu, MD

CONTACT

+86 13321922898 13321922898@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.