The Establishment of China Bronchiectasis Registry and Research Collaboration

Recruiting

• Conditions: Bronchiectasis

• Registration Number: NCT03643653
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Study Timeline

• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Study Start: 2019-01-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients enrolled in the registry	3 years	To establish a multi-centered bronchiectasis registry in Shanghai

Secondary Outcome Measures

Name	Time	Method
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.
Microbiology	At least 1 year before enrollment and 3 years during the follow-up	Sputum or bronchoalveolar lavage fluid culture
Mortality	3 years
Bronchiectasis severity Score (BSI)	At baseline and updated once a year for 3 years	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.
modified Medical Research Council (mMRC) dyspnea score	At baseline and updated once a year for 3 years	1. - 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.
Aetiology	at baseline	To analysis the possible cause of bronchiectasis in Shanghai, China.
Exacerbation	up to 3 years	Exacerbation was defined as the use of antibiotics or even hospitalization due to the worsening of symptoms or emergence of new symptoms.
Quality of Life Questionnaire-Bronchiectasis	At baseline and updated once a year for 3 years	The questionnaire asks patients questions about their current state of health. It could be downloaded from the website online.
E-FACED score	At baseline and updated once a year for 3 years	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
Comorbidity	At baseline and updated every year for up to 3 years	Comorbidity would be recorded.

Trial Locations

Locations (2)

Shanghai Pulmonary Hospital , Tongji University; 🇨🇳 Shanghai, Shanghai, China

Ruijin Hospital; 🇨🇳 Shanghai, China