Airway Clearance and Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation

NCT03643302 | Completed

• 1 other identifier: 20180717
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The changes of mMRC score before and after treatment

  7 days

• The changes of CAT score before and after treatment

  7 days

• The changes of SGRQ before and after treatment

  7 days

• The changes of LCQ before and after treatment

  7days

• The changes of 6MWD before and after treatment

  1 days

Study Arms (2)

Therapy of bronchoalveolar lavage group

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

Device: Version BF-1T26 electronic bronchoscope

Fundamental treatment group

In the control group,fundamental treatment was adopted according to the guidelines

Interventions

Version BF-1T26 electronic bronchoscope DEVICE

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

Therapy of bronchoalveolar lavage group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (3)

• 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.

  PMID: 27516225 BACKGROUND

• 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.

  PMID: 28596426 BACKGROUND

• 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.

  PMID: 34537448 DERIVED

Study Officials

• Jin-fu Xu

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of respiratory medicine

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: February 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 18, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

CN (1)