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The Establishment of China Bronchiectasis Registry and Research Collaboration

The Establishment of China Bronchiectasis Registry and the Optimal Treatment Research Collaboration for Bronchiectasis (BEChina)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03643653
Acronym
BEChina
Enrollment
10000
Registered
2018-08-23
Start date
2019-01-01
Completion date
2025-12-31
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Keywords

Bronchiectasis, multi-centered registry

Brief summary

The investigators meant to establish a multi-centered bronchiectasis patient registry for Chinese bronchiectasis patients. This would be the first bronchiectasis registry in China. Patients with all kinds of bronchiectasis would be enrolled.

Detailed description

A multi-centered bronchiectasis patient registry would be founded, which will include patients from three teaching hospital (Ruijin Hospital, Zhongshan Hospital and Shanghai Pulmonary Hospital) in Shanghai at the beginning. The network will be promoted to other cities and different places in China. Patients with bronchiectasis would be enrolled and detailed information would be recorded. Follow-up of patients would provide more information on the prognosis of disease. Optimal treatment studies for the patients will be initiated one by one based on the network. The investigators are committed to promoting clinical research and education in bronchiectasis, through sharing of protocols, research idea and expertise.

Interventions

None listed

Sponsors

Ruijin Hospital
CollaboratorOTHER
Shanghai Zhongshan Hospital
CollaboratorOTHER
Shanghai Pulmonary Hospital, Shanghai, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with bronchiectasis according to 'non-cystic fibrosis bronchiectasis guideline' published by British Thoracic Society in 2010. * Patients who are willing to sign the consent form and participate in the study.

Exclusion criteria

* Patients with incomplete essential information, which is needed for the integrity of data analysis. Essential information include CT images, respiratory sample cultures, spirometry and exacerbation history for at least one year. * Patients under 18 years old.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients enrolled in the registry3 yearsTo establish a multi-centered bronchiectasis registry in Shanghai

Secondary

MeasureTime frameDescription
Exacerbationup to 3 yearsExacerbation was defined as the use of antibiotics or even hospitalization due to the worsening of symptoms or emergence of new symptoms.
Aetiologyat baselineTo analysis the possible cause of bronchiectasis in Shanghai, China.
MicrobiologyAt least 1 year before enrollment and 3 years during the follow-upSputum or bronchoalveolar lavage fluid culture
ComorbidityAt baseline and updated every year for up to 3 yearsComorbidity would be recorded.
Lung Function (FEV1, FVC, FEV1% pred, FVC% pred etc.)recorded at baseline and re-tested every year, up to 3 years.Lung function would be tested by spirometry when patients visit the clinic.
Bronchiectasis severity Score (BSI)At baseline and updated once a year for 3 yearsThe scale is presented online. It consists of 9 items including Age, BMI(Body Mass Index), % FEV1 Predicted, Previous Hospital Admission in the past 2 years, number of exacerbations in previous year, MRC Breathlessness Score, Pseudomonas Colonisation, Colonisation with other organisms,affected lobes. 0-4 Mild Bronchiectasis. 5 - 8 Moderate Bronchiectasis. 9 + Severe Bronchiectasis.
E-FACED scoreAt baseline and updated once a year for 3 yearsIt consists of 6 items including exacerbation history in the past year, % FEV1 predicted, Age, Chronic colonization by Pseudomonas aeruginosa, n° of pulmonary lobes affected,and Dyspnea (measured by mMRC score) mild: 0-3 points, moderate: 4-6 points; and severe: 7-9 points
Mortality3 years
modified Medical Research Council (mMRC) dyspnea scoreAt baseline and updated once a year for 3 years1. \- Not troubled by breathlessness except on strenuous exercise 2. \- Short of breath when hurrying or walking up a slight hill 3. \- Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace 4. \- Stops due to breathlessness after walking 100m 5. \- House bound due to breathlessness, or breathless on dressing or undressing.
Quality of Life Questionnaire-BronchiectasisAt baseline and updated once a year for 3 yearsThe questionnaire asks patients questions about their current state of health. It could be downloaded from the website online.

Countries

China

Contacts

Primary ContactJin-Fu Xu, MD
jfxucn@163.com+86-13321922898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026