- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03643302
Airway Clearance and Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation
Clinical Efficacy and Safety of Tran-bronchoscopy Airway Clearance and Bronchoalveolar Lavage in the Treatment of Moderate to Severe Bronchiectasis With Acute Exacerbation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200000
- Shanghai pulmonary hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Therapy of bronchoalveolar lavage group
Patients with bronchiectasis exacerbations treat with fundamental treatment combining with the therapy of airway clearance and bronchoalveolar lavage.
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Interventions involving the therapy of airway clearance and bronchoalveolar lavage by Version BF-1T26 electronic bronchoscope
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Fundamental treatment group
In the control group,fundamental treatment was adopted according to the guidelines
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to the first acute exacerbation after treatment
Time Frame: 3 month
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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
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3 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The changes of mMRC score before and after treatment
Time Frame: 7 days
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Modified Medical Research Centre
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7 days
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The changes of CAT score before and after treatment
Time Frame: 7 days
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COPD Assessment Test
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7 days
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The changes of SGRQ before and after treatment
Time Frame: 7 days
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St. George respiratory questionnaire
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7 days
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The changes of LCQ before and after treatment
Time Frame: 7days
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Leicester Cough Questionnaire
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7days
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The changes of 6MWD before and after treatment
Time Frame: 1 days
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6 Minute Walking Distance
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1 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Jin-fu Xu, Shanghai Pulmonary Hospital, Shanghai, China
Publications and helpful links
General Publications
- Hill AT, Haworth CS, Aliberti S, Barker A, Blasi F, Boersma W, Chalmers JD, De Soyza A, Dimakou K, Elborn JS, Feldman C, Flume P, Goeminne PC, Loebinger MR, Menendez R, Morgan L, Murris M, Polverino E, Quittner A, Ringshausen FC, Tino G, Torres A, Vendrell M, Welte T, Wilson R, Wong C, O'Donnell A, Aksamit T; EMBARC/BRR definitions working group. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017 Jun 8;49(6):1700051. doi: 10.1183/13993003.00051-2017. Print 2017 Jun.
- McDonnell MJ, Aliberti S, Goeminne PC, Dimakou K, Zucchetti SC, Davidson J, Ward C, Laffey JG, Finch S, Pesci A, Dupont LJ, Fardon TC, Skrbic D, Obradovic D, Cowman S, Loebinger MR, Rutherford RM, De Soyza A, Chalmers JD. Multidimensional severity assessment in bronchiectasis: an analysis of seven European cohorts. Thorax. 2016 Dec;71(12):1110-1118. doi: 10.1136/thoraxjnl-2016-208481. Epub 2016 Aug 11.
- Liu Y, Lu HW, Gu SY, Wang WW, Ge J, Jie ZJ, Jia JG, Gao ZT, Li J, Shi JY, Liang S, Cheng KB, Bai JW, Qu JM, Xu JF. Bronchoscopic airway clearance therapy for acute exacerbations of bronchiectasis. EBioMedicine. 2021 Oct;72:103587. doi: 10.1016/j.ebiom.2021.103587. Epub 2021 Sep 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20180717
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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