The Establishment of China Bronchiectasis Registry and Research Collaboration

Bronchiectasis Clinical Trial

— BEChina  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03643653
• Other study ID #: 20180814
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Jin-Fu Xu, MD
• Phone: +86-13321922898
• Email: jfxucn[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai
China	Shanghai Pulmonary Hospital , Tongji University	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China	Ruijin Hospital, Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Chalmers JD, Aliberti S, Polverino E, Vendrell M, Crichton M, Loebinger M, Dimakou K, Clifton I, van der Eerden M, Rohde G, Murris-Espin M, Masefield S, Gerada E, Shteinberg M, Ringshausen F, Haworth C, Boersma W, Rademacher J, Hill AT, Aksamit T, O'Donne — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients enrolled in the registry	To establish a multi-centered bronchiectasis registry in Shanghai	3 years
Secondary	Lung Function (FEV1, FVC, FEV1% pred, FVC% pred etc.)	Lung function would be tested by spirometry when patients visit the clinic.	recorded at baseline and re-tested every year, up to 3 years.
Secondary	Exacerbation	Exacerbation was defined as the use of antibiotics or even hospitalization due to the worsening of symptoms or emergence of new symptoms.	up to 3 years
Secondary	Aetiology	To analysis the possible cause of bronchiectasis in Shanghai, China.	at baseline
Secondary	Microbiology	Sputum or bronchoalveolar lavage fluid culture	At least 1 year before enrollment and 3 years during the follow-up
Secondary	Comorbidity	Comorbidity would be recorded.	At baseline and updated every year for up to 3 years
Secondary	Quality of Life Questionnaire-Bronchiectasis	The questionnaire asks patients questions about their current state of health. It could be downloaded from the website online.	At baseline and updated once a year for 3 years
Secondary	Bronchiectasis severity Score (BSI)	The 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.	At baseline and updated once a year for 3 years
Secondary	E-FACED score	It 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	At baseline and updated once a year for 3 years
Secondary	Mortality		3 years
Secondary	modified Medical Research Council (mMRC) dyspnea score	- Not troubled by breathlessness except on strenuous exercise; - Short of breath when hurrying or walking up a slight hill; - Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace; - Stops due to breathlessness after walking 100m; - House bound due to breathlessness, or breathless on dressing or undressing.	At baseline and updated once a year for 3 years