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Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation

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ClinicalTrials.gov Identifier: NCT03643302
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary:
The therapy of Bronchoalveolar Lavage as one of the treatment of Bronchiectasis developed in recent years. This study is aim to evaluate the Clinical Efficacy and Safety of Tran-bronchoscopy Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation:An Observational Prospective Study.

Condition or disease Intervention/treatment
Bronchiectasis Adult Device: Version BF-1T26 electronic bronchoscope

Detailed Description:
The aim of this study was to evaluate the efficacy and safety of bronchoalveolar lavage for bronchiectasis patients with exacerbation through the observation of a large sample of clinical cases, which will provide a high quality of evidence-based medicine for the development, 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Efficacy and Safety of Tran-bronchoscopy Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation:An Observational Prospective Study
Actual Study Start Date : January 15, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 1, 2019

Group/Cohort Intervention/treatment
Therapy of bronchoalveolar lavage group
Patients with bronchiectasis exacerbations treat with fundamental treatment combining with the therapy of bronchoalveolar lavage.
Device: Version BF-1T26 electronic bronchoscope
Interventions involving the therapy of bronchoalveolar lavage by Version BF-1T26 electronic bronchoscope

Fundamental treatment group
Patients with bronchiectasis exacerbations treat with fundamental treatment only.



Primary Outcome Measures :
  1. The changes of life quality score before and after treatment [ Time Frame: 15 days ]
    St. George respiratory questionnaire, Modified Medical Research Centre and COPD Assessment Test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with bronchiectasis being suffering an acute exacerbation of this disease.
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 "non-cystic fibrosis bronchiectasis guideline"published by British Thoracic Society in 2010 or 2012 China bronchiectasis expert consensus, clinical symptoms of cough and expectoration, with or without intermittent hemoptysis, and chest CT showed bronchiectasis there.
  3. The definition of acute exacerbation: if there is at least one symptoms (increased sputum volume or purulent sputum, increased dyspnea, increased cough, lung function decline, increased fatigue) or new symptoms (fever, pleurisy, hemoptysis, require antimicrobial therapy), then prompted acute exacerbation.
  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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643302


Contacts
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Contact: Jin-fu Xu, MD +86 13321922898 jfxucn@163.com

Locations
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China, Shanghai
Shanghai Pulmonary Hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Kai-xing Ai    021-65115006      
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China

Publications:
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Responsible Party: Jin-Fu Xu, Director, Head of respiratory medicine, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT03643302     History of Changes
Other Study ID Numbers: 20180717
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases