Bronchiectasis AdultNCT04987827
Investigating the Clinical Features and Prognosis of Bronchiectasis Adult Patients
An observational study of Bronchiectasis Adult, run by Ruijin Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis Adult
- How many people
- 1,250 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis).
- Patients with age ≥18 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Investigating the Clinical Features and Prognosis of Bronchiectasis Adult Patients: a Multi-center, Primary Data, Cohort Study (ICON)
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.
- Conditions
- Bronchiectasis Adult
- Being tested
- No intervention
- Keywords
- Bronchiectasis, Non-Interventional Study
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchiectasis exacerbation times
Bronchiectasis exacerbation times (per person per year) during one year follow up.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Nov 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987827
- Sponsor's protocol ID
- ICON
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Clinical Features and Prognosis of Bronchiectasis Adult Patients: a Multi-center, Primary Data, Cohort Study (ICON)
- ClinicalTrials.gov ID
- NCT04987827
- Acronym / sponsor ID
- ICON
- Conditions
- Bronchiectasis Adult
- Keywords
- Bronchiectasis, Non-Interventional Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis).
- Patients with age ≥18 years old.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Bronchiectasis exacerbation times
Time frame: one year
Bronchiectasis exacerbation times (per person per year) during one year follow up.
1 secondary outcome
Proportions of different bronchiectasis exacerbations
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis Adult, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jieming Qu (86-021-64370045, jmqu0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchiectasis exacerbation times (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.