Airway Clearance and Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation

Shanghai Pulmonary Hospital, Shanghai, China

Status: Completed

Conditions: Bronchiectasis Adult

Treatments: Device: Version BF-1T26 electronic bronchoscope

Study type: Observational

Funder types: Other

Identifiers

NCT03643302

20180717

Details and patient eligibility

About

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.

Full 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.

Enrollment: 189 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

189 participants in 2 patient 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.

Treatment:

Device: Version BF-1T26 electronic bronchoscope

Fundamental treatment group

Description:

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