The Establishment of China Bronchiectasis Registry and Research Collaboration (BEChina)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Jin-Fu Xu, MD; Phone Number: +86-13321922898; Email: jfxucn@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital
    • Contact: Jie-ming Qu, MD
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Pulmonary Hospital , Tongji University
      • Contact: Kai-xing Ai; Phone Number: +86-021-65115006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with all-cause bronchiectasis would be included, such as those with tuberculosis history and genetic disorders.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients enrolled in the registry	To establish a multi-centered bronchiectasis registry in Shanghai	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Comorbidity	Comorbidity would be recorded.	At baseline and updated every year for up to 3 years
Mortality		3 years
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.
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
Aetiology	To analysis the possible cause of bronchiectasis in Shanghai, China.	at baseline
Microbiology	Sputum or bronchoalveolar lavage fluid culture	At least 1 year before enrollment and 3 years during the follow-up
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
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

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Collaborators: Shanghai Zhongshan Hospital; Ruijin Hospital
• Investigators: Study Chair: Jin-fu Xu, MD, Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

General Publications

• 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'Donnell A, Morgan L, Milenkovic B, Tramma L, Neves J, Menendez R, Paggiaro P, Botnaru V, Skrgat S, Wilson R, Goeminne P, De Soyza A, Welte T, Torres A, Elborn JS, Blasi F. The EMBARC European Bronchiectasis Registry: protocol for an international observational study. ERJ Open Res. 2016 Jan 20;2(1):00081-2015. doi: 10.1183/23120541.00081-2015. eCollection 2016 Jan.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Bronchiectasis; multi-centered registry
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 20180814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No