Investigating the Clinical Features and Prognosis of Bronchiectasis Adult Patients
1 other identifier
observational
1,250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedAugust 3, 2021
July 1, 2021
6 months
July 9, 2021
August 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bronchiectasis exacerbation times
Bronchiectasis exacerbation times (per person per year) during one year follow up.
one year
Secondary Outcomes (1)
Proportions of different bronchiectasis exacerbations
one year
Interventions
No intervention
Eligibility Criteria
It is designed that from 2021 Q4 to 2022 Q2, 1,250 bronchiectasis patients will be enrolled from 30 participating sites in China. \*Bronchiectasis exacerbation defined as patients have three or more of the following six symptoms including cough, expectoration, purulent sputum, dyspnoea, fatigue, haemoptysis, and these symptoms persist more than 48 hours, and physicians prescribe systemic antibiotics due to these symptoms.
You may qualify if:
- Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis).
- Patients with age ≥18 years old.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- AstraZenecacollaborator
Study Sites (1)
Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2021
First Posted
August 3, 2021
Study Start
November 1, 2021
Primary Completion
April 30, 2022
Study Completion
June 30, 2023
Last Updated
August 3, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share