Brief Title
Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis
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
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Improvement of Sputum volume and properties
Secondary Outcome
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))
Condition
Bronchiectasis
Intervention
Bronchoalveolar Lavage and Local Amikacin Injection
Study Arms / Comparison Groups
The experimental group
Description: fundamental treatment combining with the therapy of bronchoalveolar lavage and local Amikacin injection.(fundamental treatment including anti-infection,eliminating phlegm,oxygen therapy etc.)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
December 2014
Completion Date
June 2019
Primary Completion Date
March 2019
Eligibility Criteria
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Jin-Fu Xu, MD, +86 13321922898, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02509091
Organization ID
20150616
Responsible Party
Principal Investigator
Study Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study Sponsor
Jin-Fu Xu, MD, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China
Verification Date
August 2018