Investigating the Clinical Features and Prognosis of Bronchiectasis Adult Patients

• Conditions: Bronchiectasis Adult

• Registration Number: NCT04987827
• Lead Sponsor: Ruijin Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-08-01
• Last Update Submitted: 2021-08-01
• Study First Posted: 2021-08-03
• Last Update Posted: 2021-08-03
• Study Start: 2021-11-01
• Primary Completion: 2022-04-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bronchiectasis exacerbation times	one year	Bronchiectasis exacerbation times (per person per year) during one year follow up.

Secondary Outcome Measures

Name	Time	Method
Proportions of different bronchiectasis exacerbations	one year	Proportions of different bronchiectasis exacerbations(0, 1, 2, 3, ≥4 exacerbations per person per year) during one year follow-up.

Trial Locations

Locations (1)

Ruijin Hospital, Medical School of Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China