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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04987827
Other study ID # ICON
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date June 30, 2023

Study information

Verified date July 2021
Source Ruijin Hospital
Contact Jieming Qu
Phone 86-021-64370045
Email jmqu0906@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis.The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Different from overseas, bronchiectasis is common disease in China. This study will collect data from the real-world bronchiectasis database and follow up for one year, describe the bronchiectasis exacerbation rate and proportions for frequent exacerbation, clinical features and prognosis of bronchiectasis exacerbation, the treatment pattern (when clinically stable) during follow-up period; and describe characteristics of bronchiectasis at baseline. This study will also explore potential baseline risk factors for bronchiectasis exacerbation during follow-up period.


Description:

Bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis, its main clinical symptoms are cough, dyspnea, hemoptysis and recurrent respiratory tract infections. The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Different from overseas, bronchiectasis is common disease in China. In 2013, the prevalence rate of bronchiectasis in Chinese residents over 40 years old was 1,200/100,000. As lack of large epidemiological data in China, the prevalence rate may still be underestimated, which needs more attention and research. Bronchiectasis has heavy disease burden, characterized by recurrent acute exacerbations, high mortality, poor prognosis and heavy economic burden. The key points of bronchiectasis treatment strategy include exacerbation prevention, number of exacerbations reduction, prognosis improvement and then the quality of patients' life improvement. Therefore, it is important to describe the clinical features and prognosis of bronchiectasis (especially the incidence of acute exacerbations and the proportion of frequent exacerbations), and it would be helpful to understand the characteristics of bronchiectasis and standardize related diagnosis and treatment strategy. This study will collect data from the real-world bronchiectasis database and follow up for one year, describe the bronchiectasis exacerbation rate and proportions for frequent exacerbation, clinical features and prognosis of bronchiectasis exacerbation, the treatment pattern (when clinically stable) during follow-up period; and describe characteristics of bronchiectasis at baseline. This study will also explore potential baseline risk factors for bronchiectasis exacerbation during follow-up period.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1250
Est. completion date June 30, 2023
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis). - Patients with age =18 years old. Exclusion Criteria: - Bronchiectasis due to known cystic fibrosis. - With acute bronchiectasis exacerbation within 4 weeks before enrolment. - Participated in any interventional clinical trial within 6 months before enrolment. - Patients who are unable or unwilling to provide informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
China Ruijin Hospital, Medical School of Shanghai Jiaotong University Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Ruijin Hospital AstraZeneca Investment (China) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bronchiectasis exacerbation times Bronchiectasis exacerbation times (per person per year) during one year follow up. one year
Secondary Proportions of different bronchiectasis exacerbations Proportions of different bronchiectasis exacerbations(0, 1, 2, 3, =4 exacerbations per person per year) during one year follow-up. one year
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