The Establishment of China Bronchiectasis Registry and Research Collaboration
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|ClinicalTrials.gov Identifier: NCT03643653|
Recruitment Status : Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : July 31, 2019
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||The Establishment of China Bronchiectasis Registry and the Optimal Treatment Research Collaboration for Bronchiectasis (C-BROTH)|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
- Number of patients enrolled in the registry [ Time Frame: 3 years ]To establish a multi-centered bronchiectasis registry in Shanghai
- Lung Function (FEV1, FVC, FEV1% pred, FVC% pred etc.) [ Time Frame: recorded at baseline and re-tested every year, up to 3 years. ]Lung function would be tested by spirometry when patients visit the clinic.
- Exacerbation [ Time Frame: 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.
- Aetiology [ Time Frame: at baseline ]To analysis the possible cause of bronchiectasis in Shanghai, China.
- Microbiology [ Time Frame: At least 1 year before enrollment and 3 years during the follow-up ]Sputum or bronchoalveolar lavage fluid culture
- Comorbidity [ Time Frame: At baseline and updated every year for up to 3 years ]Comorbidity would be recorded.
- Quality of Life Questionnaire-Bronchiectasis [ Time Frame: 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.
- Bronchiectasis severity Score (BSI) [ Time Frame: 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.
- E-FACED score [ Time Frame: 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
- Mortality [ Time Frame: 3 years ]
- modified Medical Research Council (mMRC) dyspnea score [ Time Frame: At baseline and updated once a year for 3 years ]
- - 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643653
|Contact: Jin-Fu Xu, MDemail@example.com|
|Shanghai Pulmonary Hospital , Tongji University|
|Shanghai, Shanghai, China, 200000|
|Ruijin Hospital||Not yet recruiting|
|Contact: Jie-Ming Qu, MD|
|Zhongshan Hospital||Not yet recruiting|
|Contact: Yuan-Lin Song|
|Study Chair:||Jin-Fu Xu, MD||Shanghai Pulmonary Hospital, Shanghai, China|
|Study Chair:||Jie-Ming Qu, MD||Ruijin Hospital|
|Study Chair:||Yuan-Lin Song, MD||Shanghai Zhongshan Hospital|