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The Establishment of China Bronchiectasis Registry and Research Collaboration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03643653
Recruitment Status : Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : July 31, 2019
Ruijin Hospital
Shanghai Zhongshan Hospital
Information provided by (Responsible Party):
Jin-Fu Xu, 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.

Condition or disease

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. Number of patients enrolled in the registry [ Time Frame: 3 years ]
    To establish a multi-centered bronchiectasis registry in Shanghai

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Aetiology [ Time Frame: at baseline ]
    To analysis the possible cause of bronchiectasis in Shanghai, China.

  4. Microbiology [ Time Frame: At least 1 year before enrollment and 3 years during the follow-up ]
    Sputum or bronchoalveolar lavage fluid culture

  5. Comorbidity [ Time Frame: At baseline and updated every year for up to 3 years ]
    Comorbidity would be recorded.

  6. 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.

  7. 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.

  8. 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

  9. Mortality [ Time Frame: 3 years ]
  10. modified Medical Research Council (mMRC) dyspnea score [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
Whole blood would be drawn and stored at - 80℃

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03643653

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Contact: Jin-Fu Xu, MD +86-13321922898

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China, Shanghai
Shanghai Pulmonary Hospital , Tongji University
Shanghai, Shanghai, China, 200000
Ruijin Hospital Not yet recruiting
Shanghai, China
Contact: Jie-Ming Qu, MD         
Zhongshan Hospital Not yet recruiting
Shanghai, China
Contact: Yuan-Lin Song         
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Ruijin Hospital
Shanghai Zhongshan Hospital
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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

Additional Information:

Publications of Results:
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Responsible Party: Jin-Fu Xu, Chief of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, Shanghai, China Identifier: NCT03643653     History of Changes
Other Study ID Numbers: 20180814
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China:
multi-centered registry
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases