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

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02509091
• Other study ID #: 20150616
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: June 2019

Study information

• Verified date: August 2018
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Jin-Fu Xu, MD
• Phone: +86 13321922898
• Email: 13321922898[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• Bronchoalveolar Lavage and Local Amikacin Injection
injecting 0.4g of AK in 100 ml to 250 ml, not exceeding 300 ml. And generally, repeat it for 3 to 5 times.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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