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

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 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

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