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
Overview
- Phase
- Phase 4
- Intervention
- Bronchoalveolar Lavage and Local Amikacin Injection
- Conditions
- Bronchiectasis
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Improvement of Sputum volume and properties
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Jin-Fu Xu
Director, Head of respiratory medicine
Shanghai Pulmonary Hospital, Shanghai, China
Eligibility Criteria
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
Arms & Interventions
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.)
Intervention: Bronchoalveolar Lavage and Local Amikacin Injection
Outcomes
Primary Outcomes
Improvement of Sputum volume and properties
Time Frame: 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
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))(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)