Have you or your loved ones been diagnosed with bronchiectasis adult?

You may be eligible to participate in a bronchiectasis adult clinical trial.

Have you or your loved ones been diagnosed with bronchiectasis adult? You may be eligible to participate in a bronchiectasis adult clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Bronchiectasis Adult Clinical Trial in Shanghai Shanghai

NCT03643302 | Observational

Have you or your loved ones been diagnosed with bronchiectasis adult?

You may be eligible to participate in a bronchiectasis adult clinical trial.

Have you or your loved ones been diagnosed with bronchiectasis adult? You may be eligible to participate in a bronchiectasis adult clinical trial.

Completed

Male & Female

18 - 80

Years old

This study has recruited 189 Participants

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.

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Details for the study

Population

Patients with bronchiectasis being suffering an acute exacerbation of this disease.

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.

Treatments and/or Procedures

Version BF 1T26 electronic bronchoscope

Interventions involving the therapy of airway clearance and bronchoalveolar lavage by Version BF-1T26 electronic bronchoscope

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Time to the first acute exacerbation after treatment

The median time to first acute exacerbation after discharge.We used GraphPad Prism 6.0 Kaplan-Meier survival curve and the log-rank test to compare the differences of the primary outcome between both groups

3 month

Secondary

The changes of mMRC score before and after treatment

Modified Medical Research Centre

7 days

Secondary

The changes of CAT score before and after treatment

COPD Assessment Test

7 days

Secondary

The changes of SGRQ before and after treatment

St. George respiratory questionnaire

7 days

Secondary

The changes of LCQ before and after treatment

Leicester Cough Questionnaire

7days

Secondary

The changes of 6MWD before and after treatment

6 Minute Walking Distance

1 days

Study Criteria

Inclusion Criteria:

  -  Willing to join in and sign the informed consent form;

  -  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;

  -  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;

  -  According to the researchers, the subjects were willing and able to follow the
     protocol and were able to tolerate bronchoscopy;

  -  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:

  -  Pregnant or lactating women;

  -  Hypogammaglobulinemia or other autoimmune diseases;

  -  Clinical diagnosis of ABPA;

  -  Non tuberculosis mycobacteria positive 2 years before;

  -  Allergies or allergic to a variety of drugs;

  -  Poor compliance or can not cooperate judged by doctors;

  -  Participated in other clinical trials for nearly three months;

  -  The researchers considered that the subject had other circumstances that were unfit to
     attend;

  -  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;

  -  Bronchoscopy contraindication;

  -  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;

  -  Patients who refused to sign informed consent after targeted explanation.