CClinicalTrials.gg
Status unknownNCT04987827Updated Aug 3, 2021

Investigating the Clinical Features and Prognosis of Bronchiectasis Adult Patients

An observational study in Bronchiectasis Adult, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-03.

Sponsored by Ruijin Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,250
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Bronchiectasis Adult

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Keywords

  • Bronchiectasis
  • Non-Interventional Study
03

In context

Bronchiectasis

368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.

This study's planned enrollment of 1,250 is above the median of 160 across 132 observational studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,250 participants (estimated)
Patient registry
No

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. Bronchiectasis exacerbation times

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

    Time frame: one year

Secondary outcomes

  1. 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.

    Time frame: one year

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Study locations

1 site
  • Ruijin Hospital, Medical School of Shanghai Jiaotong University
    Shanghai, Shanghai 200025, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04987827
Lead sponsor
Ruijin Hospital
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Aug 3, 2021
Start date
Nov 1, 2021 (estimated)
Primary completion
Apr 30, 2022 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Aug 3, 2021

Study contacts

Jieming Qu
Contact
jmqu0906@163.com
86-021-64370045

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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