Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation

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Brief Title

Airway Clearance and Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation

Official Title

Clinical Efficacy and Safety of Tran-bronchoscopy Airway Clearance and Bronchoalveolar Lavage in the Treatment of Moderate to Severe Bronchiectasis With Acute Exacerbation

Brief Summary

      No study have evaluated the efficacy and safety of airway clearance therapy (ACT) and
      bronchoalveolar lavage (BAL) under bronchoscope for bronchiectasis.

      This study aimed to evaluate the clinical efficacy and safety of tran-bronchoscopy airway
      clearance and bronchoalveolar lavage in the treatment of moderate to severe bronchiectasis
      with acute exacerbation:A randomized, prospective cohort study.
    

Detailed Description

      The aim of this study was to evaluate the efficacy and safety of ACT combined with BAL for
      bronchiectasis patients with acute exacerbation through the whole study process, which will
      provide a high quality of evidence-based strategies for the treatment, revision and
      optimization of international and domestic clinical guidelines for bronchiectasis. All the
      participants will be required to check the various efficacy and safety indicators.
    


Study Type

Observational


Primary Outcome

Time to the first acute exacerbation after treatment

Secondary Outcome

 The changes of mMRC score before and after treatment

Condition

Bronchiectasis Adult

Intervention

Version BF-1T26 electronic bronchoscope

Study Arms / Comparison Groups

 Therapy of bronchoalveolar lavage group
Description:  Patients with bronchiectasis exacerbations treat with fundamental treatment combining with the therapy of airway clearance and bronchoalveolar lavage.

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

Device

Estimated Enrollment

189

Start Date

February 1, 2018

Completion Date

March 18, 2019

Primary Completion Date

February 28, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Willing to join in and sign the informed consent form.

          2. The diagnosis of bronchiectasis need reference to the definition of "European
             Respiratory Society guidelines for the management of adult bronchiectasis." published
             by The European respiratory journal in 2017, defined by the presence of both permanent
             bronchial dilatation on computed tomography (CT) scanning and the clinical syndrome of
             cough, sputum production and/or recurrent respiratory infections.

          3. Pulmonary exacerbation in patients with bronchiectasis was required to meet three or
             more of the following key symptoms for at least 48h: Cough; Sputum volume and/or
             consistency; Sputum purulence; Breathlessness and/or exercise tolerance; Fatigue
             and/or malaise; Haemoptysis, and a clinician determines that a change in
             bronchiectasis treatment is required.

          4. According to the researchers, the subjects were willing and able to follow the
             protocol and were able to tolerate bronchoscopy.

          5. Patients with good compliance: the subject must be willing to follow the test plan
             requirements in the research center to complete all the assessment of the visit.

        Exclusion Criteria:

        1.Pregnant or lactating women; 2.Hypogammaglobulinemia or other autoimmune diseases;
        3.Clinical diagnosis of ABPA; 4.Non tuberculosis mycobacteria positive 2 years before;
        5.allergies or allergic to a variety of drugs; 6.poor compliance or can not cooperate
        judged by doctors; 7.participated in other clinical trials for nearly three months; 8.The
        researchers considered that the subject had other circumstances that were unfit to attend;
        9.Suffering from a significant disease or condition outside of bronchiectasis, as judged by
        the researchers, may lead to subjects at risk due to participate in the study,or the
        disease that have an impact on the research result and the ability of subjects to
        participate in this study; 10.Bronchoscopy contraindication; 11.Patients with heart, liver
        and kidney, nervous system, endocrine and other systemic diseases, may not be able to
        adhere to the completion of the study, or will affect the research process; 12.Patients who
        refused to sign informed consent after targeted explanation
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Jin-fu Xu, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03643302

Organization ID

20180717


Responsible Party

Principal Investigator

Study Sponsor

Shanghai Pulmonary Hospital, Shanghai, China


Study Sponsor

Jin-fu Xu, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China


Verification Date

June 2020